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Mrad R, Al Annan K, Sayegh L, Abboud DM, Razzak FA, Kerbage A, Murad MH, Abu Dayyeh B, Brunaldi VO. Comparative effectiveness of balloons, adjustable balloons, and endoscopic sleeve gastroplasty: a network meta-analysis of randomized trials. Gastrointest Endosc 2025; 101:527.e1-527.e19. [PMID: 39490693 DOI: 10.1016/j.gie.2024.10.039] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/31/2024] [Revised: 08/17/2024] [Accepted: 10/18/2024] [Indexed: 11/05/2024]
Abstract
BACKGROUND AND AIMS Individual randomized controlled trials (RCTs) and pairwise meta-analyses do not compare all commercially available endoscopic bariatric therapies (EBTs) head-to-head. Therefore, the choice among them is currently made by inference or indirect data. We therefore assessed the comparative efficacy and safety of EBTs through a network meta-analysis. METHODS We searched MEDLINE, EMBASE, and Cochrane CENTRAL from inception for intragastric balloons (IGBs) and from 2013 for endoscopic sleeve gastroplasty (ESG) until May 2023. Only RCTs comparing any of the currently commercially available EBTs with controls were considered eligible. Outcomes included percentage of total weight loss (%TWL), serious adverse events (SAEs), and intolerability. RESULTS We identified 821 citations, of which 10 and 8 were eligible for the qualitative and quantitative analysis, respectively. Considering %TWL at the time of IGB removal, all EBTs were associated with statistically higher %TWL than controls. There were no significant differences among EBTs. However, considering the %TWL at the follow-up closest to 12 months, both ESG and the Spatz3 gastric balloon (Spatz Medical, Fort Lauderdale, Fla, USA) were more effective than the Orbera gastric balloon (Apollo Endosurgery, Austin, Tex, USA), with no statistical difference between ESG and Spatz3. For both outcomes, P score and ranking score suggested that ESG was probably associated with a greater weight loss (.889272 and .899469, respectively), followed by Spatz3 (.822894 and .842773, respectively), and Orbera (.536968 and .507165, respectively). CONCLUSIONS All currently available EBTs approved by the U.S. Food and Drug Administration are more effective than both diet plus lifestyle intervention and sham procedures with an acceptable safety profile. ESG seems the most effective and may be prioritized for patients fit for both ESG and IGBs. Direct controlled trials between EBTs are warranted to confirm these findings.
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Affiliation(s)
- Rudy Mrad
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Karim Al Annan
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Lea Sayegh
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Donna Maria Abboud
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Farah Abdul Razzak
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Anthony Kerbage
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Mohammad Hassan Murad
- Division of Public Health, Infectious Diseases and Occupational Medicine, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota, USA
| | - Barham Abu Dayyeh
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Vitor Ottoboni Brunaldi
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA; Surgery and Anatomy Department, Ribeirao Preto Medical School, University of São Paulo, São Paulo, Brazil; Gastrointestinal Endoscopy Unit, University of São Paulo Medical School, São Paulo, Brazil
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Ghusn W, Zeineddine J, Betancourt RS, Gajjar A, Yang W, Robertson AG, Ghanem OM. Advances in Metabolic Bariatric Surgeries and Endoscopic Therapies: A Comprehensive Narrative Review of Diabetes Remission Outcomes. MEDICINA (KAUNAS, LITHUANIA) 2025; 61:350. [PMID: 40005466 PMCID: PMC11857516 DOI: 10.3390/medicina61020350] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/21/2024] [Revised: 01/29/2025] [Accepted: 02/07/2025] [Indexed: 02/27/2025]
Abstract
Background and Objectives: Type 2 diabetes (T2D), closely associated with obesity, contributes to increased morbidity and mortality due to complications such as cardiometabolic disease. This review aims to evaluate the effectiveness of metabolic and bariatric surgeries (MBS) and endoscopic bariatric therapies (EBTs) in achieving diabetes remission and to examine key predictors influencing remission outcomes. Materials and Methods: This review synthesizes data from studies on MBS and EBT outcomes, focusing on predictors for diabetes remission such as preoperative insulin use, diabetes duration, HbA1c, and C-peptide levels. Additionally, predictive scoring systems, including the Individualized Metabolic Surgery (IMS), DiaRem, Advanced-DiaRem, ABCD, and Robert et al. scores, were analyzed for their utility in forecasting remission likelihood. Results: Key predictors of T2D remission include shorter diabetes duration, lower HbA1c, and higher C-peptide levels, while prolonged insulin use, and higher insulin doses are associated with lower remission rates. Scoring models like IMS and DiaRem demonstrate that lower scores correlate with a higher likelihood of remission, especially for procedures such as Roux-En-Y gastric bypass (RYGB). RYGB generally shows higher remission rates compared to sleeve gastrectomy (SG), particularly among patients with mild disease severity, while EBTs like ESG and IGBs contribute 5-20% total weight loss (TWL) and moderate glycemic control improvements. Conclusions: Both MBS and EBTs are effective for T2D management, with predictive scoring models aiding in individualized patient selection to optimize remission outcomes. Further research to validate these predictive tools across diverse populations could enhance treatment planning for both surgical and endoscopic interventions.
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Affiliation(s)
- Wissam Ghusn
- Department of Internal Medicine, Boston Medical Center, Boston, MA 02118, USA;
- Division of Gastroenterology and Hepatology, Department of Medicine, Mayo Clinic, Rochester, MN 55905, USA
| | - Jana Zeineddine
- Department of Colorectal Surgery, Massachusetts General Hospital, Boston, MA 02114, USA;
| | - Richard S. Betancourt
- Department of Surgery, Endocrine and Metabolic Surgery, Mayo Clinic, Rochester, MN 55905, USA; (R.S.B.); (A.G.)
| | - Aryan Gajjar
- Department of Surgery, Endocrine and Metabolic Surgery, Mayo Clinic, Rochester, MN 55905, USA; (R.S.B.); (A.G.)
| | - Wah Yang
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou 510632, China;
| | - Andrew G. Robertson
- Clinical Department of Surgery, University of Edinburgh, Royal Infirmary, Edinburgh EH8 9YL, UK
| | - Omar M. Ghanem
- Department of Surgery, Endocrine and Metabolic Surgery, Mayo Clinic, Rochester, MN 55905, USA; (R.S.B.); (A.G.)
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Matar RH, Abu Dayyeh BK. Advances in Endoscopic Bariatric and Metabolic Therapies. Gastroenterol Clin North Am 2024; 53:731-745. [PMID: 39489584 DOI: 10.1016/j.gtc.2024.08.017] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/05/2024]
Abstract
This article presents an overview of endoscopic bariatric and metabolic therapies (EBMTs) as emerging minimally invasive interventions for obesity and its related comorbidities. It explores various gastric and small-bowel endoscopic procedures, including their mechanisms, clinical outcomes, and safety profiles.
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Affiliation(s)
- Reem H Matar
- Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA
| | - Barham K Abu Dayyeh
- Division of Gastroenterology and Hepatology, Mayo Clinic, 200 First Street Southwest, Rochester, MN, USA.
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De Luca M, Zese M, Bandini G, Zappa MA, Bardi U, Carbonelli MG, Carrano FM, Casella G, Chianelli M, Chiappetta S, Iossa A, Martinino A, Micanti F, Navarra G, Piatto G, Raffaelli M, Romano E, Rugolotto S, Serra R, Soricelli E, Vitiello A, Schiavo L, Zani ICM, Ragghianti B, Lorenzoni V, Medea G, Antognozzi V, Bellini R, Berardi G, Campanile FC, Facchiano E, Foletto M, Gentileschi P, Olmi S, Petrelli M, Pilone V, Sarro G, Ballardini D, Bettini D, Costanzi A, Frattini F, Lezoche G, Neri B, Porri D, Rizzi A, Rossini R, Sessa L, D'Alessio R, Di Mauro G, Tolone S, Bernante P, Docimo L, Foschi D, Angrisani L, Basso N, Busetto L, Di Lorenzo N, Disoteo O, Forestieri P, Musella M, Paolini B, Silecchia G, Monami M. SICOB Italian clinical practice guidelines for the surgical treatment of obesity and associated diseases using GRADE methodology on bariatric and metabolic surgery. Updates Surg 2024:10.1007/s13304-024-01996-z. [PMID: 39419949 DOI: 10.1007/s13304-024-01996-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 09/09/2024] [Indexed: 10/19/2024]
Abstract
Obesity is a chronic disease associated with increased morbidity and mortality and reduced quality of life. Pharmacotherapy can be associated with life style changes in increasing and maintaining weight loss and ameliorating obesity-related complications and comorbidities. In patients affected by obesity and uncontrolled obesity-associated complications or high degrees of BMI (> 40 Kg/m2), metabolic bariatric surgery can be a valid therapeutic option. Many different types of surgical procedures have been developed in last decades, mainly performed via laparoscopic approaches. However, clinical indications for metabolic and bariatric surgery (MBS) and the choice of the most appropriate type of procedure have not been clarified so far.The Italian Society of Bariatric and Metabolic Surgery for Obesity (Società Italiana di Chirurgia dell'Obesità e delle Malattie Metaboliche-SICOB) decided to design and develop the updated version of the Italian guidelines aimed at assisting healthcare professionals in the choice of the surgical option for the treatment of obesity and related conditions. Between June and October 2022, a panel of 24 experts and an evidence review team (ERT, 10 members), participated in the definition of clinical questions, outcomes, and recommendations and collected and analyzed all the available evidence on the basis of pre-specified search strategies. GRADE methodology and PICO (Patient, Intervention, Comparison, Outcome) conceptual framework have been adopted for the development of the present guidelines. Aim of the present guideline is to verify indications to surgery with respect to the presence of comorbid conditions, evaluate the different types of surgical approaches and endoscopic bariatric procedure and revise indication to revision surgery and postoperative procedures.
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Affiliation(s)
- Maurizio De Luca
- Rovigo Hospital, ULSS5 Polesana, Viale Tre Martini, Rovigo, Italy
| | - Monica Zese
- Rovigo Hospital, ULSS5 Polesana, Viale Tre Martini, Rovigo, Italy.
| | - Giulia Bandini
- Azienda Ospedaliero Universitaria Careggi and University of Florence, Florence, Italy
| | | | - Ugo Bardi
- Casa Di Cura Privata Salus SpA, Salerno, Italy
| | | | | | - Giovanni Casella
- Università Degli Studi Di Roma La Sapienza, AOU Policlinico Umberto I, Rome, Italy
| | | | | | - Angelo Iossa
- Sapienza Università Di Roma, Polo Ospedaliero Integrato Università Ausl Lt Latina, Latina, Italy
| | | | - Fausta Micanti
- Università Degli Studi Di Napoli "Federico II", Naples, Italy
| | | | | | - Marco Raffaelli
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Rome, Italy
| | | | - Simone Rugolotto
- Rovigo Hospital, ULSS5 Polesana, Viale Tre Martini, Rovigo, Italy
| | | | | | | | - Luigi Schiavo
- Università Degli Studi Di Salerno A.O.U. San Giovanni Di Dio E Ruggi D'Aragona Ospedale G. Fucito, Salerno, Italy
| | | | - Benedetta Ragghianti
- Azienda Ospedaliero Universitaria Careggi and University of Florence, Florence, Italy
| | | | | | | | | | | | | | | | | | | | | | | | - Vincenzo Pilone
- Università Degli Studi Di Salerno A.O.U. San Giovanni Di Dio E Ruggi D'Aragona, Salerno, Italy
| | - Giuliano Sarro
- Istituto Ad Alta Specializzazione - San Gaudenzio, Novara, Italy
| | | | - Dario Bettini
- Azienda AUSL Della Romagna Ospedale G.B.Morgagni-L.Pierantoni, Forlì Cesena, Italy
| | | | | | | | | | | | | | | | - Luca Sessa
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Università Cattolica del Sacro Cuore, Rome, Italy
| | | | - Gianluca Di Mauro
- Azienda Ospedaliero Universitaria "G. Rodolico- San Marco", Catania, Italy
| | | | - Paolo Bernante
- Centro Interaziendale Chirurgia Metabolica e obesità IRCCS Policlinico Sant'Orsola Ausl Bentivoglio, Bologna, Italy
| | | | | | - Luigi Angrisani
- Ospedale Santa Maria La Bruna, Torre del Greco, Naples, Italy
| | | | - Luca Busetto
- Policlinico Universitario Di Padova, Padua, Italy
| | | | - Olga Disoteo
- ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy
| | | | - Mario Musella
- Università Degli Studi Di Napoli "Federico II", Naples, Italy
| | | | | | - Matteo Monami
- Azienda Ospedaliero Universitaria Careggi and University of Florence, Florence, Italy
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Domènech E, Ciudin A, Balibrea JM, Espinet-Coll E, Cañete F, Flores L, Ferrer-Márquez M, Turró R, Hernández-Camba A, Zabana Y, Gutiérrez A. Recommendations on the management of severe obesity in patients with inflammatory bowel disease of the Spanish Group on Crohn's Disease and Ulcerative Colitis (GETECCU), Spanish Society of Obesity (SEEDO), Spanish Association of Surgery (AEC) and Spanish Society of Digestive Endoscopy (SEED). GASTROENTEROLOGIA Y HEPATOLOGIA 2024; 47:906-923. [PMID: 38290648 DOI: 10.1016/j.gastrohep.2023.12.008] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/18/2023] [Accepted: 12/19/2023] [Indexed: 02/01/2024]
Abstract
Obesity is a multifactorial, chronic, progressive and recurrent disease considered a public health issue worldwide and an important determinant of disability and death. In Spain, its current prevalence in the adult population is about 24% and an estimated prevalence in 2035 of 37%. Obesity increases the probability of several diseases linked to higher mortality such as diabetes, cardiovascular disease, hyperlipidemia, arterial hypertension, non-alcoholic fatty liver disease, several types of cancer, or obstructive sleep apnea. On the other hand, although the incidence of inflammatory bowel disease (IBD) is stabilizing in Western countries, its prevalence already exceeds 0.3%. Paralleling to general population, the current prevalence of obesity in adult patients with IBD is estimated at 15-40%. Obesity in patients with IBD could entail, in addition to its already known impact on disability and mortality, a worse evolution of the IBD itself and a worse response to treatments. The aim of this document, performed in collaboration by four scientific societies involved in the clinical care of severe obesity and IBD, is to establish clear and concise recommendations on the therapeutic possibilities of severe or typeIII obesity in patients with IBD. The document establishes general recommendations on dietary, pharmacological, endoscopic, and surgical treatment of severe obesity in patients with IBD, as well as pre- and post-treatment evaluation.
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Affiliation(s)
- Eugeni Domènech
- Servicio de Aparato Digestivo, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, España; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD); Departament de Medicina, Universitat Autònoma de Barcelona, Barcelona, España.
| | - Andreea Ciudin
- Departament de Fisiologia i Immunologia, Universitat Autònoma de Barcelona, Barcelona, España; Servicio de Endocrinología y Nutrición, Hospital Universitari Vall d'Hebron, Barcelona, España; Diabetes and Metabolism Research Unit, Vall d'Hebron Institut de Recerca (VHIR), Barcelona, España
| | - José María Balibrea
- Servicio de Cirugía General y Digestiva, Hospital Universitari Germans Trias i Pujol; Departamento de Cirugía, Universitat Autònoma de Barcelona, Badalona, Barcelona, España
| | - Eduard Espinet-Coll
- Unidad de Endoscopia Bariátrica, Hospital Universitario Dexeus y Clínica Diagonal, Barcelona, España
| | - Fiorella Cañete
- Servicio de Aparato Digestivo, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, España; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD)
| | - Lilliam Flores
- Centro de Investigación Biomédica en Red de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM); Unidad de Obesidad, Servicio de Endocrinología y Nutrición, Hospital Clínic, Barcelona, España
| | - Manuel Ferrer-Márquez
- Servicio de Cirugía General y Digestiva, Hospital Universitario Torrecárdenas, Almería, España
| | - Román Turró
- Unidad de Endoscopia Digestiva, Bariátrica y Metabólica, Servicio de Aparato Digestivo, Centro Médico Teknon y Hospital Quirón, Barcelona, España
| | - Alejandro Hernández-Camba
- Servicio de Aparato Digestivo, Hospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife, España
| | - Yamile Zabana
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD); Servicio de Aparato Digestivo, Hospital Universitari Mútua de Terrassa, Terrassa, Barcelona, España
| | - Ana Gutiérrez
- Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD); Servicio de Aparato Digestivo, Hospital General Universitario Dr. Balmis, ISABIAL, Instituto de Investigación Sanitaria y Biomédica de Alicante, Alicante, España
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Jirapinyo P, Hadefi A, Thompson CC, Patai ÁV, Pannala R, Goelder SK, Kushnir V, Barthet M, Apovian CM, Boskoski I, Chapman CG, Davidson P, Donatelli G, Kumbhari V, Hayee B, Esker J, Hucl T, Pryor AD, Maselli R, Schulman AR, Pattou F, Zelber-Sagi S, Bain PA, Durieux V, Triantafyllou K, Thosani N, Huberty V, Sullivan S. American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity. Gastrointest Endosc 2024; 99:867-885.e64. [PMID: 38639680 DOI: 10.1016/j.gie.2023.12.004] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/07/2023] [Accepted: 12/07/2023] [Indexed: 04/20/2024]
Abstract
This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥ 30 kg/m2, or with a BMI of 27.0-29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.
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Affiliation(s)
- Pichamol Jirapinyo
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
| | - Alia Hadefi
- Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Hôpital Universitaire de Bruxelles, Brussels, Belgium
| | - Christopher C Thompson
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
| | - Árpád V Patai
- Department of Surgery, Transplantation and Gastroenterology, Semmelweis University, Budapest, Hungary
| | - Rahul Pannala
- Department of Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, Arizona, USA
| | - Stefan K Goelder
- Department of Gastroenterology, University Hospital Augsburg, Augsburg, Germany
| | - Vladimir Kushnir
- Department of Medicine-Division of Gastroenterology, Washington University, Washington University School of Medicine in St Louis, St Louis, Missouri, USA
| | - Marc Barthet
- Department of Hepatogastroenterology, Faculty of Medicine, Aix-Marseille University, Chemin des Bourrely, Marseille, France
| | - Caroline M Apovian
- Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
| | - Ivo Boskoski
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, and Centre for Endoscopic Research Therapeutics and Training, Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, Italy
| | - Christopher G Chapman
- Center for Interventional and Therapeutic Endoscopy, Division of Digestive Diseases and Nutrition, Rush University, Chicago, Illinois USA
| | - Paul Davidson
- Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Gianfranco Donatelli
- Unité d'Endoscopie Interventionnelle, Hôpital Privé des Peupliers, Ramsay Générale de Santé, Paris, France and Department of Clinical Medicine and Surgery, University of Naples "Federico II," Naples, Italy
| | - Vivek Kumbhari
- Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA
| | - Bu Hayee
- Division of Gastroenterology, Kings College London, London, United Kingdom
| | - Janelle Esker
- Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Aurora, Colorado, USA
| | - Tomas Hucl
- Department of Gastroenterology and Hepatology, Institute of Clinical and Experimental Medicine, Prague, Czech Republic
| | - Aurora D Pryor
- Department of Surgery, Long Island Jewish Medical Center, Queens, New York, USA
| | - Roberta Maselli
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy and Humanitas Clinical and Research Center IRCCS, Endoscopy Unit, Rozzano, Italy
| | - Allison R Schulman
- Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA
| | - Francois Pattou
- Department of Endocrine and Metabolic Surgery, CHU Lille, University of Lille, Inserm, Institut Pasteur Lille, Lille, France
| | - Shira Zelber-Sagi
- School of Public Health, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel and Department of Gastroenterology, Tel Aviv Medical Center, Tel Aviv, Israel
| | - Paul A Bain
- Countway Library of Medicine, Harvard Medical School, Boston, Massachusetts, USA
| | - Valérie Durieux
- Bibliothèque des Sciences de la Santé, Université Libre de Bruxelles, Brussels, Belgium
| | - Konstantinos Triantafyllou
- Hepatogastroenterology Unit, Second Department of Internal Medicine-Propaedeutic, Medical School, National and Kapodistrian University of Athens, "Attikon" University General Hospital, Athens, Greece
| | - Nirav Thosani
- Center for Interventional Gastroenterology at UTHealth, Division of Gastroenterology Hepatology and Nutrition, McGovern Medical School, Houston, Texas, USA
| | - Vincent Huberty
- Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Hôpital Universitaire de Bruxelles, Brussels, Belgium
| | - Shelby Sullivan
- Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Aurora, Colorado, USA
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Papakostas P, Tzikos G, Pyankova G, Menni AE, Pourtoulidou DF, Shrewsbury AD, Lidoriki I, Stelmach V, Fyntanidou B, Grosomanidis V, Stavrou G, Kotzampassi K. Changes in Food Preferences Before and After Intragastric Balloon Placement. Obes Surg 2024; 34:2091-2100. [PMID: 38703243 DOI: 10.1007/s11695-024-07233-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/18/2023] [Revised: 04/08/2024] [Accepted: 04/16/2024] [Indexed: 05/06/2024]
Abstract
BACKGROUNDS In recent years, numerous studies have tried to decode the way bariatric surgery works toward weight reduction by the use of food preference questionnaires. The intragastric balloon has gained popularity, mainly due to its limited invasiveness, in patients with obesity not fulfilling criteria for bariatric surgery. However, there is no study assessing the changes in food preferences [FP]. We decided to analyze the FP of individuals prior to intragastric balloon insertion and following its removal, on the strict condition that participants must complete the 6-month treatment period and attend at least 4 of the 7 follow-up interviews. METHODS Patients were asked to rate the frequency of consumption of 63 food items before balloon insertion, at monthly intervals and after balloon removal. The food categories were protein, carbohydrates, fruit and vegetables, and sweets and fats. RESULTS The questionnaires of 320 participants were analyzed. A reduced frequency in consumption of meat and meat products, high-fat, and high-carbohydrate/sugary products and an increase in raw vegetables and fruit was found in all individuals. CONCLUSION The intragastric balloon seems to exert analogically similar mechanisms to bariatric surgery for weight loss, both functioning through alterations in FP. These are dictated by the anatomical re-configuration of the stomach, but mainly by counseling of dieticians and the self-education of the patient after experiencing unpleasant postprandial discomfort.
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Affiliation(s)
- Pyrros Papakostas
- Department of Surgery, Aristotle Univesity of Thessaloniki, 54636, Thessaloniki, Greece
| | - Georgios Tzikos
- Department of Surgery, Aristotle Univesity of Thessaloniki, 54636, Thessaloniki, Greece
| | - Gerry Pyankova
- Department of Surgery, Aristotle Univesity of Thessaloniki, 54636, Thessaloniki, Greece
| | | | | | - Anne D Shrewsbury
- Department of Surgery, Aristotle Univesity of Thessaloniki, 54636, Thessaloniki, Greece
| | - Irene Lidoriki
- First Department of Surgery, National & Kapodistrian University of Athens, Athens, Greece
| | - Veroniki Stelmach
- Department of Surgery, Aristotle Univesity of Thessaloniki, 54636, Thessaloniki, Greece
| | - Barbara Fyntanidou
- Department of Surgery, Aristotle Univesity of Thessaloniki, 54636, Thessaloniki, Greece
| | - Vasilis Grosomanidis
- Department of Surgery, Aristotle Univesity of Thessaloniki, 54636, Thessaloniki, Greece
| | - George Stavrou
- Department of Surgery, Aristotle Univesity of Thessaloniki, 54636, Thessaloniki, Greece
| | - Katerina Kotzampassi
- Department of Surgery, Aristotle Univesity of Thessaloniki, 54636, Thessaloniki, Greece.
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Jirapinyo P, Hadefi A, Thompson CC, Patai ÁV, Pannala R, Goelder SK, Kushnir V, Barthet M, Apovian CM, Boskoski I, Chapman CG, Davidson P, Donatelli G, Kumbhari V, Hayee B, Esker J, Hucl T, Pryor AD, Maselli R, Schulman AR, Pattou F, Zelber-Sagi S, Bain PA, Durieux V, Triantafyllou K, Thosani N, Huberty V, Sullivan S. American Society for Gastrointestinal Endoscopy-European Society of Gastrointestinal Endoscopy guideline on primary endoscopic bariatric and metabolic therapies for adults with obesity. Endoscopy 2024; 56:437-456. [PMID: 38639680 DOI: 10.1055/a-2292-2494] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 04/21/2024]
Abstract
This joint ASGE-ESGE guideline provides an evidence-based summary and recommendations regarding the role of endoscopic bariatric and metabolic therapies (EBMTs) in the management of obesity. The document was developed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) framework. It evaluates the efficacy and safety of EBMT devices and procedures that currently have CE mark or FDA-clearance/approval, or that had been approved within five years of document development. The guideline suggests the use of EBMTs plus lifestyle modification in patients with a BMI of ≥30 kg/m2, or with a BMI of 27.0-29.9 kg/m2 with at least 1 obesity-related comorbidity. Furthermore, it suggests the utilization of intragastric balloons and devices for endoscopic gastric remodeling (EGR) in conjunction with lifestyle modification for this patient population.
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Affiliation(s)
- Pichamol Jirapinyo
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
| | - Alia Hadefi
- Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Hôpital Universitaire de Bruxelles, Brussels, Belgium
| | - Christopher C Thompson
- Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
| | - Árpád V Patai
- Department of Surgery, Transplantation and Gastroenterology, Semmelweis University, Budapest, Hungary
| | - Rahul Pannala
- Department of Gastroenterology and Hepatology, Mayo Clinic, Scottsdale, Arizona, USA
| | - Stefan K Goelder
- Department of Gastroenterology, University Hospital Augsburg, Augsburg, Germany
| | - Vladimir Kushnir
- Department of Medicine-Division of Gastroenterology, Washington University, Washington University School of Medicine in St Louis, St Louis, Missouri, USA
| | - Marc Barthet
- Department of Hepatogastroenterology, Faculty of Medicine, Aix-Marseille University, Chemin des Bourrely, Marseille, France
| | - Caroline M Apovian
- Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA
| | - Ivo Boskoski
- Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, and Centre for Endoscopic Research Therapeutics and Training, Department of Translational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, Italy
| | - Christopher G Chapman
- Center for Interventional and Therapeutic Endoscopy, Division of Digestive Diseases and Nutrition, Rush University, Chicago, Illinois USA
| | - Paul Davidson
- Department of Surgery, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Gianfranco Donatelli
- Unité d'Endoscopie Interventionnelle, Hôpital Privé des Peupliers, Ramsay Générale de Santé, Paris, France and Department of Clinical Medicine and Surgery, University of Naples "Federico II," Naples, Italy
| | - Vivek Kumbhari
- Division of Gastroenterology and Hepatology, Mayo Clinic, Jacksonville, Florida, USA
| | - Bu Hayee
- Division of Gastroenterology, Kings College London, London, United Kingdom
| | - Janelle Esker
- Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Aurora, Colorado, USA
| | - Tomas Hucl
- Department of Gastroenterology and Hepatology, Institute of Clinical and Experimental Medicine, Prague, Czech Republic
| | - Aurora D Pryor
- Department of Surgery, Long Island Jewish Medical Center, Queens, New York, USA
| | - Roberta Maselli
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Italy and Humanitas Clinical and Research Center IRCCS, Endoscopy Unit, Rozzano, Italy
| | - Allison R Schulman
- Division of Gastroenterology and Hepatology, University of Michigan, Ann Arbor, Michigan, USA
| | - Francois Pattou
- Department of Endocrine and Metabolic Surgery, CHU Lille, University of Lille, Inserm, Institut Pasteur Lille, Lille, France
| | - Shira Zelber-Sagi
- School of Public Health, Faculty of Social Welfare and Health Sciences, University of Haifa, Haifa, Israel and Department of Gastroenterology, Tel Aviv Medical Center, Tel Aviv, Israel
| | - Paul A Bain
- Countway Library of Medicine, Harvard Medical School, Boston, Massachusetts, USA
| | - Valérie Durieux
- Bibliothèque des Sciences de la Santé, Université Libre de Bruxelles, Brussels, Belgium
| | - Konstantinos Triantafyllou
- Hepatogastroenterology Unit, Second Department of Internal Medicine-Propaedeutic, Medical School, National and Kapodistrian University of Athens, "Attikon" University General Hospital, Athens, Greece
| | - Nirav Thosani
- Center for Interventional Gastroenterology at UTHealth, Division of Gastroenterology Hepatology and Nutrition, McGovern Medical School, Houston, Texas, USA
| | - Vincent Huberty
- Department of Gastroenterology, Hepatopancreatology, and Digestive Oncology, CUB Hôpital Erasme, Université Libre de Bruxelles, Hôpital Universitaire de Bruxelles, Brussels, Belgium
| | - Shelby Sullivan
- Division of Gastroenterology and Hepatology, University of Colorado School of Medicine, Aurora, Colorado, USA
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Martins MF, De la Hoz Gomez A, Manivannan A, Shapira‐Daniels A, Campbell Reardon CL. Gastric outlet obstruction due to an intragastric balloon in a patient returning from the Caribbean. Clin Case Rep 2024; 12:e8509. [PMID: 38333653 PMCID: PMC10849985 DOI: 10.1002/ccr3.8509] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/13/2023] [Revised: 01/17/2024] [Accepted: 01/19/2024] [Indexed: 02/10/2024] Open
Abstract
Key Clinical Message Gastric outlet obstruction can be a dangerous complication of intragastric balloons, as it can result in severe metabolic alkalosis. As weight loss procedures and medical tourism become more popular, physicians should have a high index of suspicion for complications of invasive procedures, particularly in returning travelers. Abstract Intragastric balloons for weight loss have decreased in frequency in the United States. However, they are still frequent in low- and middle-income countries. Severe complications occur in less than 3% of patients who undergo this procedure. Herein, we present a case of gastric outlet obstruction, severe metabolic alkalosis, and refeeding syndrome in a patient returning from the Dominican Republic. She presented with 2 weeks of emesis and obstipation, followed by a pre-syncope and altered mental status. An intragastric mass was observed on computerized tomography, which was characterized as an intragastric balloon and retrieved endoscopically. All metabolic derangements were corrected, and the patient improved without sequelae. As weight loss procedures and medical tourism become more popular, physicians should have a high index of suspicion for complications of invasive procedures, particularly in returning travelers.
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10
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Weitzner ZN, Phan J, Begashaw MM, Mak SS, Booth MS, Shekelle PG, Maggard-Gibbons M, Girgis MD. Endoscopic therapies for patients with obesity: a systematic review and meta-analysis. Surg Endosc 2023; 37:8166-8177. [PMID: 37730854 PMCID: PMC10615978 DOI: 10.1007/s00464-023-10390-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/05/2023] [Accepted: 08/12/2023] [Indexed: 09/22/2023]
Abstract
BACKGROUND Obesity is a major threat to public health and traditional bariatric surgery continues to have low utilization. Endoscopic treatments for obesity have emerged that offer less risk, but questions remain regarding efficacy, durability, and safety. We compared the efficacy of endoscopic bariatric procedures as compared to other existing treatments. METHODS A literature search of Embase, Cochrane Central, and Pubmed was conducted from January 1, 2014 to December 7, 2021, including endoscopic bariatric therapies that were FDA or CE approved at the time of search to non-endoscopic treatments. Thirty-seven studies involving 15,639 patients were included. Primary outcomes included % total body weight loss (%TBWL), % excess body weight loss (%EBWL), and adverse events. Secondary outcomes included quality of life data and differences in hemoglobin A1C levels. Strength of clinical trial and observational data were graded according to the Cochrane methods. RESULTS Intragastric balloons achieved greater %TBWL with a range of 7.6-14.1% compared to 3.3-6.7% with lifestyle modification at 6 months, and 7.5-14.0% compared to 3.1-7.9%, respectively, at 12 months. When endoscopic sleeve gastroplasty (ESG) was compared to laparoscopic sleeve gastrectomy (LSG), ESG had less %TBWL at 4.7-14.4% compared to 18.8-26.5% after LSG at 6 months, and 4.5-18.6% as compared to 28.4-29.3%, respectively, at 12 months. For the AspireAssist, there was greater %TBWL with aspiration therapy compared to lifestyle modification at 12 months, 12.1-18.3% TBWL versus 3.5-5.9% TBWL, respectively. All endoscopic interventions had higher adverse events rates compared to lifestyle modification. CONCLUSION This review is the first to evaluate various endoscopic bariatric therapies using only RCTs and observational studies for evaluation of weight loss compared with conservative management, lifestyle modification, and bariatric surgery. Endoscopic therapies result in greater weight loss compared to lifestyle modification, but not as much as bariatric surgery. Endoscopic therapies may be beneficial as an alternative to bariatric surgery.
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Affiliation(s)
- Zachary N Weitzner
- Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, 757 Westwood Plaza, Los Angeles, CA, 90095, USA
| | - Jennifer Phan
- Department of Gastroenterology, Keck School of Medicine, University of Southern California, Los Angeles, USA
| | - Meron M Begashaw
- Veterans Health Administration, Greater Los Angeles Healthcare System, Los Angeles, USA
| | - Selene S Mak
- Veterans Health Administration, Greater Los Angeles Healthcare System, Los Angeles, USA
| | | | - Paul G Shekelle
- Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, 757 Westwood Plaza, Los Angeles, CA, 90095, USA
- Veterans Health Administration, Greater Los Angeles Healthcare System, Los Angeles, USA
| | - Melinda Maggard-Gibbons
- Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, 757 Westwood Plaza, Los Angeles, CA, 90095, USA
- Veterans Health Administration, Greater Los Angeles Healthcare System, Los Angeles, USA
| | - Mark D Girgis
- Department of Surgery, David Geffen School of Medicine, University of California Los Angeles, 757 Westwood Plaza, Los Angeles, CA, 90095, USA.
- Veterans Health Administration, Greater Los Angeles Healthcare System, Los Angeles, USA.
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11
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Swei E, Almuhaidb A, Sullivan S, Al-Shahrani A, D'Souza FR, Altayar O, Bell S, Maday R, Wagh MS, Mullady D, Bennett M, Early D, Kushnir V. Comparison of the Efficacy and Safety of the FDA-approved Intragastric Balloon Systems in a Clinical Setting. J Clin Gastroenterol 2023; 57:578-585. [PMID: 35604348 DOI: 10.1097/mcg.0000000000001718] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/11/2021] [Accepted: 03/30/2022] [Indexed: 12/10/2022]
Abstract
BACKGROUND AND AIMS The gas-filled intragastric balloon (IGB) system (Obalon) and the fluid-filled IGB system (Orbera) are the current FDA-approved IGB systems to treat obesity; however, they have not been previously compared in clinical practice. The aims of this study were to compare their efficacy, tolerance, and safety in a clinical setting. MATERIALS AND METHODS This is a retrospective cohort study of consecutive patients treated with the gas-filled IGB or fluid-filled IGB between October 2015 and May 2020 at 2 academic centers. The primary endpoints included percent total body weight loss at balloon removal in patients who completed at least 20 weeks of therapy, the difference in adverse events that required urgent evaluation or hospitalization, and early removal in the 2 groups. RESULTS A total of 87 patients underwent successful IGB placement (gas-filled IGB n=57, age 48.9±8.8, body mass index 35.5±5 kg/m 2 ; fluid-filled IGB n=30, age 49.2±14.3, body mass index 38.8±6 kg/m 2 ). Eleven patients underwent early device removal. There were no differences in percent total body weight loss at balloon removal and 12 months between the balloon systems ( P =0.39). Patients who received the fluid-filled IGB were more likely to require urgent evaluation or treatment, require hospital stay >24 hours, and need early balloon system removal compared with patients treated with the gas-filled IGB. CONCLUSION In this 2-center cohort, both FDA-approved gastric balloon systems had the same effectiveness, but the gas-filled IGB had fewer serious adverse events and better tolerability than the fluid-filled IGB.
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Affiliation(s)
- Eric Swei
- Division of Gastroenterology, University of Colorado School of Medicine, Aurora, CO
| | | | - Shelby Sullivan
- Division of Gastroenterology, University of Colorado School of Medicine, Aurora, CO
| | | | - Felicia R D'Souza
- Division of Hospital Medicine, Washington University School of Medicine in St. Louis, St. Louis, MO
| | | | | | | | - Mihir S Wagh
- Division of Gastroenterology, University of Colorado School of Medicine, Aurora, CO
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12
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Jerez J, Cabrera D, Cisneros C, Moreno M, Guaitara D, Benavides C, Fors M, Falcon K. INTRAGASTRIC BALLOON AND IMPACT ON WEIGHT LOSS: EXPERIENCE IN QUITO, EQUADOR. ARQUIVOS BRASILEIROS DE CIRURGIA DIGESTIVA : ABCD = BRAZILIAN ARCHIVES OF DIGESTIVE SURGERY 2023; 36:e1731. [PMID: 37255102 DOI: 10.1590/0102-672020230002e1731] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 01/16/2022] [Accepted: 01/30/2023] [Indexed: 06/01/2023]
Abstract
BACKGROUND Obesity is associated with different medical conditions, such as cardiologic, respiratory, gastrointestinal, and genitourinary, and constitutes a severe health problem. AIMS This study aimed to evaluate the use of intragastric fluid-filled balloon in the reduction of weight and other measurements related to body composition. METHODS This is a retrospective, monocentric study involving all patients who opted for the intragastric balloon Spatz® placement from January 2018 to July 2019, with fulfillment of inclusion and exclusion criteria. The patients were analyzed after 6 and 12 months after the intragastric fluid-filled balloon placed. RESULTS A total of 121 subjects were included in this study, with 83 (68.6%) females and 38 (31.4%) males. The mean age was 36 years and height was 1.64±0.09. Weight mean and standard deviation was 89.85±14.65 kg, and body mass index was 33.05±4.03; body mass index decreased to 29.4 kg/m2 with a mean weight of 79.83 kg, after 12 months of follow-up. There were statistical differences between body mass index and the 12 months in fat percentage, fat-free mass (kg), visceral fat area, and basal metabolic rate. There was a significant variation according to gender, with males having highest reduction. The percentage of excess weight loss was 46.19, and the total weight loss was 9.24 at the end of the study. CONCLUSIONS The study demonstrated a benefit of intragastric fluid-filled balloon on weight loss after 12 months. At the end of treatment, body mass index and the measurements of body composition were significantly lower. Men benefited more than women from the treatment.
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Affiliation(s)
| | | | | | | | | | | | - Martha Fors
- Universidad de las Américas, Faculty of Health Sciences - Quito, Equador
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13
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Dave N, Dawod E, Simmons OL. Endobariatrics: a Still Underutilized Weight Loss Tool. CURRENT TREATMENT OPTIONS IN GASTROENTEROLOGY 2023; 21:172-184. [PMID: 37284352 PMCID: PMC10163575 DOI: 10.1007/s11938-023-00420-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Accepted: 03/08/2023] [Indexed: 06/08/2023]
Abstract
Purpose of review Bariatric and metabolic endoscopic therapies provide an option for patients seeking clinically significant weight loss with fewer adverse events than conventional bariatric surgery. Our aims are to provide an overview of the current state of primary endoscopic treatment options for weight loss and to emphasize the importance of including these therapies when presenting weight loss options to qualified patients. Recent findings Bariatric endoscopy procedures are associated with a lower adverse event rate when compared to bariatric surgery and result in more weight loss than most existing pharmacotherapies approved by the Food and Drug Administration. Summary Sufficient evidence exists to implement bariatric endoscopic therapies-namely, the intragastric balloon and endoscopic sleeve gastroplasty-as safe and effective treatment options for weight loss when used in combination with lifestyle changes. However, bariatric endoscopy remains an underutilized option by weight management providers. Future studies are needed to identify patient and provider-level barriers to adopting endoscopic bariatric therapies as an option for the treatment of obesity.
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Affiliation(s)
- Niel Dave
- Division of Gastroenterology at HCA Florida Aventura Hospital, 20900 Biscayne Blvd, Aventura, FL 33180 USA
| | - Enad Dawod
- Division of Gastroenterology, Weill Cornell Medicine, New York Presbyterian Hospital, 1305 York Avenue, 4th Floor, New York, NY 10021 USA
| | - Okeefe L. Simmons
- Simmons MD Advanced Weight Loss Solutions, 2820 NE 214th Street, Suite 1002, Miami, FL 33180 USA
- Division of Gastroenterology, Miami Veterans Affairs Healthcare System, 1201 NW 16th Street, Miami, FL 33125 USA
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14
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Vijayaraghavan R, Sarin SK, Bharadwaj A, Anand L, Maiwall R, Choudhury A, Benjamin J, Kanal U, Jamwal KD. Intragastric Balloon in Obese Compensated Nonalcoholic Steatohepatitis Cirrhosis Patients Is Safe and Achieves Significant Weight Reduction at 6-Months. Dig Dis Sci 2023; 68:1035-1041. [PMID: 35763235 DOI: 10.1007/s10620-022-07596-4] [Citation(s) in RCA: 6] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/11/2021] [Accepted: 05/31/2022] [Indexed: 12/09/2022]
Abstract
BACKGROUND AND STUDY AIMS Weight reduction is the mainstay treatment for Nonalcoholic steatohepatitis (NASH). intragastric balloon (IGB) placement has proven benefit in terms of weight reduction. The aim of the present study is to assess the safety and efficacy of IGB placement in compensated NASH cirrhosis. PATIENTS AND METHODS Nonalcoholic steatohepatitis cirrhosis patients with CTP ≤ 7, BMI of > 30, and who were unable to achieve weight reduction with lifestyle modification in past 3 months were prospectively enrolled. Spatz3™ adjustable gastric balloon was placed endoscopically. Primary objective was to determine efficacy in weight loss at 6 months, with secondary objectives of reduction in hepatic venous pressure gradient (HVPG), liver fat (controlled attenuation parameter, CAP), liver stiffness measurement (LSM) and clinical events as well as the tolerability and adverse events due to IGB placement. RESULTS Altogether 56 cirrhosis patients, with a baseline BMI of 35.24 ± 3.92 and a CTP score of 6.27 ± 1.28 underwent IGB placement. The absolute weight reduction achieved was 15.88 kg (- 16.46%) and reduction in BMI was - 10.1% at 6 months. The percentage total body weight loss of ≥ 10% was achieved in 31 (55.35%) patients. The reduction in HVPG at 6-months was 11.12% (n = 16, 14.18 ± 2.12 to 12.60 ± 1.67 mmHg). The mean reduction in LSM was 28.6% and in CAP was 10.09%. Three (5.36%) patients required removal of IGB before 6-months due to persisting vomiting. No patient developed new-onset decompensation or any serious adverse event. CONCLUSION IGB placement is a safe, well tolerated and effective option for reduction in weight and portal pressure in compensated obese cirrhosis patients. TRIAL REGISTRY Clinicaltrails.gov identifier no: NCT03753438.
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Affiliation(s)
- Rajan Vijayaraghavan
- Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India
| | - Shiv K Sarin
- Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India.
- Department of Hepatology, Institute of Liver and Biliary Sciences, D-1 Vasant Kunj, New Delhi, 110070, India.
| | - Ankit Bharadwaj
- Department of Epidemiology and Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, India
| | - Lovkesh Anand
- Department of Gastroenterology, Manipal Hospital, New Delhi, India
| | - Rakhi Maiwall
- Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India
| | - Ashok Choudhury
- Department of Hepatology, Institute of Liver and Biliary Sciences, New Delhi, India
| | - Jaya Benjamin
- Department of Clinical Nutrition, Institute of Liver and Biliary Sciences, New Delhi, India
| | - Uma Kanal
- Department of Clinical Nutrition, Institute of Liver and Biliary Sciences, New Delhi, India
| | - Kapil Dev Jamwal
- Department of Gastroenterology, Artemis Hospitals, Gurugram, Haryana, India
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15
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Genco A, Ernesti I, Watanabe M. Intragastric Balloon Treatment for Obesity. OBESITY, BARIATRIC AND METABOLIC SURGERY 2023:927-938. [DOI: 10.1007/978-3-030-60596-4_50] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/03/2025]
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AL M. Comparison of The Short-Term Effects of Intragastric Balloon and Botulinum Toxin Injection On Weight Loss. ARCHIVES OF CLINICAL AND EXPERIMENTAL MEDICINE 2022. [DOI: 10.25000/acem.1168617] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/28/2022] Open
Abstract
Aim: To compare the effects of endoscopic intragastric balloon (IGB) placement and intragastric botulinum toxin-A (BTX-A) injection in terms of weight loss among patients with non-morbid obesity.
Methods: This retrospective single center study was conducted between 01.08.2020 and 01.01.2022. A total of 39 patients with a body mass index (BMI) of <40 without comorbidities were included in the study. Nineteen underwent intragastric BTX-A injection and 20 underwent IGB placement. Patients were evaluated 1 month and 6 months after the procedures.
Results: Mean age was 39.4 ± 8.6 in the BTX-A group and 37.3 ± 10.4 in the IGB group (p = 0.496). 78.9% of the BTX-A group and 75.0% of the IGB group were female (p = 1.000). In both groups, the median weight 1 month after the procedure was significantly lower than before the procedure, and the median weight 6 months after the procedure was significantly lower than 1 month after the procedure (p<0.001 for both groups). The median weight loss in the IGB group at both the 1st and 6th months was significantly greater than the corresponding values of the BTX-A group (p < 0.001 for both).
Conclusion: IGB insertion appears to be a more successful endoscopic bariatric procedure than intragastric BTX-A injection, as measured by weight loss at post-intervention 1 month and 6 months. IGB may be preferred in patients with a BMI below 40 without obesity-related comorbidity.
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17
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Muacevic A, Adler JR, de Souza TF, Galvão Neto MDP, Grecco E, Waisberg J. Gastric Emptying and Its Correlation With Weight Loss and Body Mass Index in Patients With an Intragastric Balloon: A Prospective Study With Six Years of Follow-Up. Cureus 2022; 14:e32599. [PMID: 36654650 PMCID: PMC9840869 DOI: 10.7759/cureus.32599] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 12/16/2022] [Indexed: 12/23/2022] Open
Abstract
Background Obesity is the most well-established and prolonged pandemic in modern society. Having a better understanding of the available tools is important to improve weight loss and make the strategies more productive. This study aims to evaluate the effect of intragastric balloon (IGB) on gastric emptying time, its relationship with weight loss after IGB removal, and weight maintenance after six years. Methodology This prospective study analyzed data from patients undergoing IGB placement. A six-years follow-up was performed and data about weight maintenance were collected. We analyzed the impact of the IGB on gastrointestinal motility and its correlation with weight loss. Results Of the 20 patients included in the study, 52.4% were diagnosed with class I obesity and 47.6% with class II obesity. The mean weight of the patients was 96.5 ± 11.9 kg at baseline, 79.6 ± 11.4 kg at the time of IGB removal, 81.8 ± 9.1 kg at six months, and 93.2 ± 14.3 kg six years after IGB removal. The mean difference between the initial weight and that measured immediately after IGB removal was 16.68 ± 5.71 kg. Regarding gastric emptying time, there was a difference in retention on comparing the measurement before balloon placement to that after the balloon was in place (72.9% vs. 86.8%) after one hour of food intake. Comparing two hours after food intake, patients before IGB placement had a 30.6% food retention, while patients with IGB in place had a 69.2% retention. Conclusions In patients with class I or II obesity, the use of an IGB delayed gastric emptying of foods but showed no direct correlation with weight loss. Weight loss achieved after IGB placement was maintained in half of the patients at a six-year follow-up.
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18
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Effects on physiologic measures of appetite from intragastric balloon and endoscopic sleeve gastroplasty: results of a prospective study. Chin Med J (Engl) 2022; 135:1234-1241. [PMID: 35788090 PMCID: PMC9337251 DOI: 10.1097/cm9.0000000000002097] [Citation(s) in RCA: 14] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022] Open
Abstract
Background: Endoscopic bariatric therapies can help address widening management gaps in obesity. Their ability to facilitate weight loss is largely tied to influences on appetite through perturbations of gastric emptying and accommodation. As these tools gain traction in obesity therapy, their physiologic underpinnings require exploration, which may enhance efficacy, tolerance, and patient-tailored care. Methods: We prospectively assessed consecutive subjects with fluid-filled intragastric balloons (IGBs) (n = 18) placed between October 2016 and June 2017 or underwent endoscopic sleeve gastroplasty (ESG) (n = 23) from March 2018 to June 2018. Patients underwent physiologic appraisal at 3 months with 13C-spirulina-based gastric emptying breath test to determine time to half emptying (T50), as well as maximum tolerated volume (MTV) of a standard nutrient drink test. Changes in T50 and MTV at 3 months were compared with percent total body weight loss (%TBWL) at 3 and 6 months using best-fit linear regression. Results: The change in T50 at 3 months correlated with %TBWL at 3 months for IGB (P = 0.01) and ESG (P = 0.01) but with greater impact on %TBWL in IGB compared to ESG (R2 = 0.42 vs. 0.26). Change in T50 at 3 months was predictive of weight loss at 6 months for IGB (P = 0.01) but not ESG (P = 0.11). ESG was associated with greater decrease in MTV compared to IGB (340.25 ± 297.97 mL vs. 183.00 ± 217.13 mL, P = 0.08), indicting an enhanced effect on satiation through decreased gastric accommodation. Changes in MTV at 3 months did not correlate with %TBWL for either IGB (P = 0.26) or ESG (P = 0.49) but trended toward significance for predicting %TBWL at 6 months for ESG (P = 0.06) but not IGB (P = 0.19). Conclusion: IGB and ESG both induce weight loss but likely through distinct gastric motor function phenotypes, and gastric emptying may predict future weight loss in patients with IGB.
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Lee SY, Lai H, Chua YJ, Wang MX, Lee GH. Endoscopic Bariatric and Metabolic Therapies and Their Effects on Metabolic Syndrome and Non-alcoholic Fatty Liver Disease - A Systematic Review and Meta-Analysis. Front Med (Lausanne) 2022; 9:880749. [PMID: 35615095 PMCID: PMC9124896 DOI: 10.3389/fmed.2022.880749] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/21/2022] [Accepted: 04/12/2022] [Indexed: 11/13/2022] Open
Abstract
BackgroundEndoscopic bariatric and metabolic therapies (EBMTs) are procedures that utilize instruments that require flexible endoscopy or placement of devices for inducing weight loss. We perform a systematic review and meta-analysis to evaluate four modalities – intragastric balloon (IGB), endoscopic sleeve gastroplasty (ESG), duodeno-jejunal bypass liner (DJBL), and duodenal mucosa resurfacing (DMR), for their efficacy and safety on weight loss, non-alcoholic fatty liver disease, and metabolic syndrome.MethodsDatabases MEDLINE via PubMed, and EMBASE are searched and relevant publications up to January 26, 2022 are assessed. Studies are included if they involved human participants diagnosed with obesity and obesity-related comorbid conditions who are treated with any of the 4 EBMTs. IGB and DJBL were chosen as the interventions for the meta-analysis with weight loss (percentage total body weight loss or body mass index) and glycemic control (fasting plasma glucose or HbA1c) as the two main outcomes analyzed.ResultsSix hundred and forty-eight records are reviewed, of which 15 studies are found to be duplicates. Of the 633 records screened, 442 studies are excluded. One hundred and ninety-one articles are assessed for eligibility, for which 171 are excluded. A total of 21 publications are included. Twelve studies are on IGB, two studies on ESG, five studies on DJBL, and two studies on DMR. In these studies with appropriate control, IGB, ESG, and DJBL showed promising benefits on weight loss reduction compared to standard medical therapy (SMT), while DMR appeared to have the least weight reduction benefit. However, the impact on glycemic control featured more prominently in DMR as compared to the rest of the modalities. Different EBMTs have different adverse effect profiles, although device-related adverse events are featured more prominently in DJBL. In the IGB group, there was a significant reduction in 6-month %TBWL [weighted mean difference (WMD) 5.45 (3.88, 7.05)] and FPG WMD −4.89 mg/dL (−7.74, −2.04) compared to the SMT group. There was no significant reduction in BMI between the DJBL and SMT group WMD −2.73 (−5.52, 0.07) kg/m2.ConclusionEBMTs have demonstrated a significant impact on weight loss and metabolic comorbidities, and reasonable safety profiles in the studies reviewed. Some data is available to demonstrate reduction of hepatic steatosis, but there is no high-quality data supporting benefits on hepatic lobular inflammation or fibrosis.
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Affiliation(s)
- Shi-Yan Lee
- Gastroenterology & Hepatology, National University Hospital, Singapore, Singapore
| | - Haoxing Lai
- Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Yang Jie Chua
- Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
| | - Min Xian Wang
- Saw Swee Hock School of Public Health, National University of Singapore and National University Health System, Singapore, Singapore
- Centre of Infectious Disease Epidemiology and Research, National University of Singapore, Singapore, Singapore
| | - Guan-Huei Lee
- Gastroenterology & Hepatology, National University Hospital, Singapore, Singapore
- Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore
- *Correspondence: Guan-Huei Lee
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Jamal MH, Al-Kanawati N, ElAbd R, Al-Haddad M, AlKhadher T, Hamshari F, Akrouf S. A Study Examining the Orbera365 Intragastric Balloon Safety and Effects on Weight Loss. Obes Surg 2021; 31:5342-5347. [PMID: 34591263 PMCID: PMC8482955 DOI: 10.1007/s11695-021-05729-8] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/20/2021] [Revised: 09/16/2021] [Accepted: 09/22/2021] [Indexed: 11/28/2022]
Abstract
INTRODUCTION The Orbera365 is a new balloon that can stay in the stomach for up to 12 months. The aim of this study is to investigate the safety and effect of Orbera365. METHOD Prospective study on our initial experience with a consecutive group of patients who underwent the insertion of Orbera365 in the period between September 2019 and August 2020. The patients were followed up to assess, pain, nausea, and vomiting after procedure, weight loss, and the complication rate. RESULTS A total of 97 patients underwent Orbera365 placement. Mean weight and BMI before the procedure were 93.8 ± 15.2 kg and 35.2 ± 4.4 kg/m2, respectively, which dropped to 80.6 ± 13.1 kg and 29.8 ± 4.0 kg/m2 by 8.2 months and were 82.4 ± 16.1 and 30.4 ± 4.6 at the last day of follow-up of 12.9 months. Fourteen patients did not tolerate the balloon, and had to have it removed, six of them in the first week, and eight within the first 8 months of insertion. Other than intolerance, two patients had balloon rupture, three patients had leakage at time of insertion requiring balloon replacement, two patient had pancreatitis, one patient had spontaneous balloon hyperinflation, and one patient had balloon deflation and vomited the balloon. At day of last follow-up, total body weight loss % (TBWL%) was 16.2 ± 10.1 and %EWL was 54.6 ± 38.3. CONCLUSION Orbera365 is safe and effective for weight loss.
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Affiliation(s)
- Mohammad H Jamal
- Department of Surgery, Faculty of Medicine, Health Sciences Center, Kuwait University, Kuwait City, Kuwait. .,Obesity and Metabolic Unit, The Clinic, Kuwait City, Kuwait.
| | | | - Rawan ElAbd
- Department of Surgery, Faculty of Medicine, Health Sciences Center, Kuwait University, Kuwait City, Kuwait
| | | | | | | | - Shehab Akrouf
- Department of Surgery, Amiri Hospital, Kuwait City, Kuwait
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21
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Watt KD, Heimbach JK, Rizk M, Jaruvongvanich P, Sanchez W, Port J, Venkatesh SK, Bamlet H, Tiedtke K, Malhi H, Acosta Cardenas A, Grothe K, Clark M, Mundi MS, Abu Dayyeh BK. Efficacy and Safety of Endoscopic Balloon Placement for Weight Loss in Patients With Cirrhosis Awaiting Liver Transplantation. Liver Transpl 2021; 27:1239-1247. [PMID: 33866660 DOI: 10.1002/lt.26074] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/14/2021] [Revised: 03/25/2021] [Accepted: 04/02/2021] [Indexed: 12/13/2022]
Abstract
The efficacy and safety of a fluid-filled intragastric balloon (IGB) for weight loss in patients with cirrhosis on the liver transplantation (LT) waiting list is unknown. We enrolled stable compensated patients with body mass index >35 kg/m2 and on the waiting list for IGB placement endoscopically for a maximum of 6 months. A total of 8 patients (7 men) aged mean ± SD, 56 ± 4.6 years with Model for End-Stage Liver Disease-sodium (MELD-Na) scores 14.1 ± 3.4 experienced weight reduction (146 ± 22.2 kg versus 127 ± 21.6 kg [P = 0.005] with IGB in place and 130 ± 24.6 kg [P = 0.014] at 6 months), with a total body weight loss of 12.2% ± 8.8% with IGBs in place and 10.9% ± 8.9% at 6 months. Body fat decreased from 48.6% ± 5.8% to 40.6% ± 6.4% (P = 0.001) and lean mass increased from 51.3% ± 6% to 59.4% ± 6.4% (P = 0.001). No change in MELD-Na scores occurred (P = 0.770). Early balloon retrieval was attributed to accommodative symptoms (n = 2) and liver decompensation (n = 1). Mallory Weiss tears (n = 3), but no portal hypertensive bleeding, occurred. Liver decompensation and/or hepatocellular carcinoma (HCC) developed in 3 patients. A total of 4 patients with LT ± sleeve gastrectomy maintained overall weight loss. Of 4 patients who did not receive transplants, 2 experienced weight regain. IGB results in short-term weight loss in patients with cirrhosis awaiting LT, with body fat loss without lean mass loss. Adverse effects were common. Decompensation and HCC did occur, with uncertainty of the relation to weight loss, and thus careful patient selection and close follow-up are required.
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Affiliation(s)
- Kymberly D Watt
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN
| | | | - Monika Rizk
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN
| | | | - William Sanchez
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN
| | - John Port
- Department of Radiology, Mayo Clinic, Rochester, MN
| | | | - Heather Bamlet
- Department of Clinical Nutrition, Mayo Clinic, Rochester, MN
| | - Kathryn Tiedtke
- Department of Clinical Nutrition, Mayo Clinic, Rochester, MN
| | - Harmeet Malhi
- Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN
| | | | - Karen Grothe
- Department of Psychology, Mayo Clinic, Rochester, MN
| | - Matthew Clark
- Department of Psychology, Mayo Clinic, Rochester, MN
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Mehta A, Sharaiha RZ. Bariatric and metabolic endoscopy: impact on obesity and related comorbidities. Ther Adv Gastrointest Endosc 2021; 14:26317745211019156. [PMID: 34179778 PMCID: PMC8193659 DOI: 10.1177/26317745211019156] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/21/2020] [Accepted: 04/16/2021] [Indexed: 12/26/2022] Open
Abstract
The global obesity pandemic is among the most significant public health crises today. Furthermore, obesity remains a major risk factor for many weight-related comorbid conditions including cardiovascular disease, type 2 diabetes mellitus, liver disease, and cancer. Endoscopic bariatric therapies are currently on the rise as a new tool in the fight against the obesity epidemic, offering patients an alternative to more invasive surgery and a more effective option than diet and lifestyle modifications. The aim of this review article is to summarize the current literature regarding endoscopic bariatric therapies and their impact on obesity and its associated metabolic complications.
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Affiliation(s)
- Amit Mehta
- Division of Gastroenterology and Hepatology, Weill Cornell Medicine and NewYork-Presbyterian Hospital, New York, NY, USA
| | - Reem Z Sharaiha
- Associate Professor of Medicine, Division of Gastroenterology and Hepatology, Weill Cornell Medicine and NewYork-Presbyterian Hospital, New York, NY 10021, USA
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23
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Safety and Effectiveness of an Intragastric Balloon as an Adjunct to Weight Reduction in a Post-Marketing Clinical Setting. Obes Surg 2021; 30:4267-4274. [PMID: 32617919 DOI: 10.1007/s11695-020-04798-5] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
BACKGROUND AND OBJECTIVES Obesity and its related comorbidities are associated with serious health risks. This trial evaluated the safety and effectiveness of the ORBERA® Intragastric Balloon System (IGB) as an adjunct to lifestyle intervention in a post-marketing clinical setting. METHODS AND MATERIALS In this multicenter study, 258 adults with a body mass index of 30-40 kg/m2 were treated with the IGB as an adjunct to weight reduction and followed for up to 12 months. The primary objective was to demonstrate in a post-marketing clinical setting that the incidence of device and procedure-related serious adverse events (SAEs) after 26 weeks of IGB treatment is no greater than 15%. RESULTS The incidence of device and procedure-related SAEs was 8.9% with a 1-sided upper limit confidence interval of 12.4%, compared with the 9.6% overall SAE rate seen in the US pivotal study; therefore, the primary safety endpoint was met. The key secondary effectiveness endpoint was also met with a mean maximum %TBWL of 12.5 being achieved at the time of IGB removal (26 weeks). CONCLUSIONS The post-marketing safety and effectiveness profile of the IGB are consistent with what was observed in the US pivotal study. No new risks were identified. CLINICAL TRIAL REGISTRATION CLINICAL TRIALS.GOV NCT02828657.
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24
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Singh S, de Moura DTH, Khan A, Bilal M, Chowdhry M, Ryan MB, Bazarbashi AN, Thompson CC. Intragastric Balloon Versus Endoscopic Sleeve Gastroplasty for the Treatment of Obesity: a Systematic Review and Meta-analysis. Obes Surg 2021; 30:3010-3029. [PMID: 32399847 DOI: 10.1007/s11695-020-04644-8] [Citation(s) in RCA: 31] [Impact Index Per Article: 7.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
BACKGROUND We aimed to individually evaluate IGB and ESG procedures and compare the efficacy, durability, and safety of these procedures. METHODS Bibliographic databases were systematically searched for studies investigating the use of IGB and ESG for the treatment of obesity. Studies reporting percent total weight loss (%TWL) or percent excess weight loss (%EWL) with at least 12 months of follow-up were included. RESULTS A total of 28 studies were included in the final analysis. Only 1 study directly compared ESG to IGB, 9 studies evaluated ESG alone, while 18 studies evaluated IGB. At 12-month follow-up after ESG, mean %TWL was 17.51 (95% CI 16.44-18.58), and %EWL was 60.51 (95% CI 54.39-66.64). Mean %TWL and %EWL after IGB at 12 months was 10.35 (95% CI 8.38-12.32) and 29.65 (95% CI 25.40-33.91), respectively. Mean %TWL and %EWL after IGB were significantly decreased at 18 or 24 months compared to 6 months indicating weight regain after IGB removal. ESG achieved significantly superior weight loss compared to IGB, the difference in mean %TWL was 7.33 (95% CI 5.22-9.44, p value = 0.0001) at 12 months. Serious adverse events were observed in < 5% for both procedures. CONCLUSION Although ESG and IGB are safe and effective for weight loss, our study suggests that ESG results in more significant and sustained weight loss. Nevertheless, a variety of approaches are essential to care for this underserved population, and there are several factors other than weight loss that should be considered in selecting the ideal therapy for individual patients.
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Affiliation(s)
- Shailendra Singh
- Division of Gastroenterology, West Virginia University Health Sciences Center Charleston Division, Charleston, WV, USA.
| | | | - Ahmad Khan
- Department of Medicine, West Virginia University Health Sciences Center Charleston Division, Charleston, WV, USA
| | - Mohammad Bilal
- Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA
| | - Monica Chowdhry
- Department of Medicine, West Virginia University Health Sciences Center Charleston Division, Charleston, WV, USA
| | - Michele B Ryan
- Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
| | - Ahmad Najdat Bazarbashi
- Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
| | - Christopher C Thompson
- Division of Gastroenterology, Hepatology, and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA
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25
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Shah R, Davitkov P, Abu Dayyeh BK, Saumoy M, Murad MH. AGA Technical Review on Intragastric Balloons in the Management of Obesity. Gastroenterology 2021; 160:1811-1830. [PMID: 33832658 DOI: 10.1053/j.gastro.2021.02.043] [Citation(s) in RCA: 13] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
Several strategies are available to address the obesity epidemic and range from noninvasive lifestyle interventions to medications and bariatric surgical procedures. Endoscopic bariatric techniques, such as intragastric balloons, have become an attractive alternative as a tool for weight loss that can augment the effect of lifestyle interventions. This technical review includes multiple systematic reviews performed to support a clinical practice guideline by the American Gastroenterological Association on the role of intragastric balloons as a tool for weight loss. The systematic reviews targeted a priori selected clinical questions about the effectiveness and periprocedural care of intragastric balloons and concomitant and subsequent weight-loss strategies.
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Affiliation(s)
- Raj Shah
- Case Western Reserve University School of Medicine, Cleveland, Ohio; Veterans Affairs, Northeast Ohio Healthcare System, Cleveland, Ohio; University Hospitals Cleveland Medical Center, Cleveland, Ohio
| | - Perica Davitkov
- Case Western Reserve University School of Medicine, Cleveland, Ohio; Veterans Affairs, Northeast Ohio Healthcare System, Cleveland, Ohio
| | - Barham K Abu Dayyeh
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota
| | - Monica Saumoy
- Division of Gastroenterology and Hepatology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania
| | - M Hassan Murad
- Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, Minnesota
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26
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Cho JH, Bilal M, Kim MC, Cohen J. The Clinical and Metabolic Effects of Intragastric Balloon on Morbid Obesity and Its Related Comorbidities. Clin Endosc 2021; 54:9-16. [PMID: 33684281 PMCID: PMC7939781 DOI: 10.5946/ce.2020.302] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/18/2020] [Revised: 01/10/2021] [Accepted: 01/12/2021] [Indexed: 12/16/2022] Open
Abstract
Obesity is becoming increasingly prevalent worldwide, and its metabolic sequelae lead to a significant burden on healthcare resources. Options for the management of obesity include lifestyle modification, pharmacological treatment, surgery, and endoscopic bariatric therapies (EBTs). Among these, EBTs are more effective than diet and lifestyle modification and are less invasive than bariatric surgery. In recent years, there have been significant advances in technologies pertaining to EBTs. Of all the available EBTs, there is a significant amount of clinical experience and published data regarding intragastric balloons (IGBs) because of their comparatively long development period. Currently, the United States Food and Drug Administration (FDA) has approved three IGBs, including Orbera (Apollo Endosurgery, Austin, TX, USA), ReShape Duo (ReShape Medical, San Clemente, CA, USA), and Obalon (Obalon Therapeutics, Carlsbad, CA, USA). The aim of this review is to summarize the available literature on the efficacy of IGBs in weight loss and their impact on obesity-related metabolic diseases.
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Affiliation(s)
- Joon Hyun Cho
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea
| | - Mohammad Bilal
- Center for Advanced Endoscopy, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA
| | - Min Cheol Kim
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea
| | - Jonah Cohen
- Center for Advanced Endoscopy, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA
| | - The Study Group for Endoscopic Bariatric and Metabolic Therapies of the Korean Society of Gastrointestinal Endoscopy
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea
- Center for Advanced Endoscopy, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA
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Affiliation(s)
- Dana A Telem
- Department of Surgery, University of Michigan, Ann Arbor
- Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor
| | - Amir A Ghaferi
- Department of Surgery, University of Michigan, Ann Arbor
- Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor
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28
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Phan PT, Tiong AMH, Miyasaka M, Cao L, Kaan HL, Ho KY, Phee SJ. EndoPil: A Magnetically Actuated Swallowable Capsule for Weight Management: Development and Trials. Ann Biomed Eng 2020; 49:1391-1401. [PMID: 33215368 DOI: 10.1007/s10439-020-02692-w] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/02/2020] [Accepted: 11/11/2020] [Indexed: 01/17/2023]
Abstract
Intragastric balloons (IGBs), by occupying the stomach space and prolonging satiety, is a promising method to treat obesity and consequently improves its associated comorbidities, e.g. coronary heart disease, diabetes, and cancer. However, existing IGBs are often tethered with tubes for gas or liquid delivery or require endoscopic assistance for device delivery or removal, which are usually uncomfortable, costly, and may cause complications. This paper presents a novel tetherless, magnetically actuated capsule (EndoPil) which can deploy an IGB inside the stomach after being swallowed and being activated by an external magnet. The external magnet attracts a small magnet inside the EndoPil to open a valve, triggering the chemical reaction of citric acid and potassium bicarbonate to produce carbon dioxide gas, which inflates a biocompatible balloon (around 120 mL). A prototype, 13 mm in diameter and 35 mm in length, was developed. Simulations and bench-top tests were conducted to test the force capability of the magnetic actuation mechanism, the required force to activate the valve, and the repeatability of balloon inflation. Experiments on animal and human were successfully conducted to demonstrate the safety and feasibility of inflating a balloon inside the stomach by an external magnet.
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Affiliation(s)
- Phuoc Thien Phan
- School of Mechanical & Aerospace Engineering, Nanyang Technological University, Singapore, Singapore
| | - Anthony Meng Huat Tiong
- School of Mechanical & Aerospace Engineering, Nanyang Technological University, Singapore, Singapore
| | - Muneaki Miyasaka
- School of Mechanical & Aerospace Engineering, Nanyang Technological University, Singapore, Singapore
| | - Lin Cao
- School of Mechanical & Aerospace Engineering, Nanyang Technological University, Singapore, Singapore.
| | - Hung Leng Kaan
- Department of General Surgery, National University Hospital, Singapore, Singapore
| | - Khek Yu Ho
- Department of Medicine, National University of Singapore, Singapore, Singapore
| | - Soo Jay Phee
- School of Mechanical & Aerospace Engineering, Nanyang Technological University, Singapore, Singapore
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Jung SH, Yoon JH, Choi HS, Nam SJ, Kim KO, Kim DH, Kim JW, Sohn W, Hyun YS, Park CH, Lee HL. Comparative efficacy of bariatric endoscopic procedures in the treatment of morbid obesity: a systematic review and network meta-analysis. Endoscopy 2020; 52:940-954. [PMID: 32325513 DOI: 10.1055/a-1149-1862] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
BACKGROUND The comparative efficacy of bariatric endoscopic procedures has not been completely elucidated. We aimed to comprehensively evaluate the efficacy of bariatric endoscopic procedures. METHODS We searched for randomized controlled trials investigating the efficacy of bariatric endoscopic procedures, including the use of an intragastric balloon, duodenal-jejunal bypass liner (DJBL), aspiration therapy, primary obesity surgery endoluminal (POSE) procedure, and botulinum toxin injection to the stomach. Network meta-analyses were performed to determine the percentage of weight loss (%weight loss) and percentage of excess weight loss (%EWL). RESULTS 22 studies with 2141 patients were included in the meta-analysis. Most endoscopic procedures showed superior efficacy in terms of %weight loss compared with the control (mean difference [MD] [95 % confidence interval (CI)]: aspiration therapy 10.4 % [7.0 % to 13.7 %]; fluid-filled balloon 5.3 % [3.4 % to 7.2 %]; POSE 4.9 % [1.7 % to 8.2 %]; and DJBL 4.5 % [1.4 % to 7.7 %]). In terms of %EWL, aspiration therapy, fluid-filled balloon, POSE, and DJBL were superior to the control (MD [95 %CI]: 27.3 % [15.3 % to 39.3 %]; 22.4 % [15.4 % to 29.4 %]; 15.3 % [2.5 % to 28.0 %]; and 13.0 % [4.9 % to 21.2], respectively). The gas-filled balloon and botulinum toxin injection did not show a significant difference in %weight loss or %EWL compared with the control. For the fluid-filled balloon, the %EWL and %weight loss tended to decrease after balloon removal at 6 months after the procedure. CONCLUSION All bariatric endoscopic procedures, except for gas-filled balloon and botulinum toxin injection to the stomach, showed superior short-term efficacy in terms of %weight loss or %EWL compared with lifestyle modification.
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Affiliation(s)
- Sung Hoon Jung
- Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
| | - Jai Hoon Yoon
- Division of Gastroenterology, Department of Internal Medicine, Hanyang University Hospital, Hanyang University College of Medicine, Seoul, Korea
| | - Hyuk Soon Choi
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea
| | - Seung-Joo Nam
- Department of Internal Medicine, Kangwon National University School of Medicine, Chuncheon, Korea
| | - Kyoung Oh Kim
- Division of Gastroenterology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea
| | - Do Hoon Kim
- Department of Gastroenterology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
| | - Jung-Wook Kim
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kyung Hee University School of Medicine, Seoul, Korea
| | - Won Sohn
- Division of Gastroenterology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Yil Sik Hyun
- Division of Gastroenterology, Department of Internal Medicine, Seoul Chuk Hospital, Seoul, Korea
| | - Chan Hyuk Park
- Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Korea
| | - Hang Lak Lee
- Division of Gastroenterology, Department of Internal Medicine, Hanyang University Hospital, Hanyang University College of Medicine, Seoul, Korea
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Taha O, Abdelaal M, Asklany A, Alaa M, Belal S, El Assal I, Shahin M, Abubasha A, Elbanhawy D. Outcomes of a Swallowable Intragastric Balloon (Elipse™) on 96 Overweight and Obese Patients. Obes Surg 2020; 31:965-969. [PMID: 33118134 DOI: 10.1007/s11695-020-05086-y] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/15/2020] [Revised: 10/15/2020] [Accepted: 10/21/2020] [Indexed: 02/06/2023]
Abstract
BACKGROUND The traditional gastric balloons have been used for several years to reduce weight in overweight and obese patients, but the need for sedation and upper endoscopy leading to several limitations. The current series is the first study that evaluates the safety and effectiveness of the swallowable gastric (Elipse™) balloon in our population on the national level. METHODS Ninety-six patients (mean BMI was 33.6 ± 4.3 kg/m2) participated in this study. All patients swallowed one Elipse™ balloon intended to remain in the stomach for 4 months, self-empty, and then pass. Each balloon was filled with 550 mL of filling fluid. Anti-emetics and anti-spasmodic drugs were prescribed for 2-3 days after insertion; proton pump inhibitor was prescribed twice daily 1 week before the procedure and continued until the end of residence time (16-20 weeks). RESULTS In the current series, at end of the procedure (after 4 months), the overall mean weight loss (WL) was 11.2 ± 5.1 kg, mean waist circumference reduction was 10.9 ± 2.1 cm, and a mean BMI reduction was 4.9 ± 2.0 kg/m2. The percentage of total body weight loss (TBWL%) was 12.1 ± 5.2%. The Elipse™ therapy reported improvements in the metabolic parameters investigated. CONCLUSION This swallowable gastric balloon (Elipse™) can be safely and successfully swallowed, filled, imaged, and passed with accepted weight loss and clinical improvement in factors related to the metabolic syndrome.
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Affiliation(s)
- Osama Taha
- Bariatric Unit, Plastic and Obesity Surgery Department, Assiut University Hospital, Assiut, Egypt
- Osama Taha Group Clinics, Cairo, Egypt
| | - Mahmoud Abdelaal
- Bariatric Unit, Plastic and Obesity Surgery Department, Assiut University Hospital, Assiut, Egypt.
- Osama Taha Group Clinics, Cairo, Egypt.
| | - Awny Asklany
- Bariatric Unit, Plastic and Obesity Surgery Department, Assiut University Hospital, Assiut, Egypt
- Osama Taha Group Clinics, Cairo, Egypt
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Do Endoscopic Bariatric Procedures Improve Postprocedural Quality of Life and Mental Health? A Systematic Review and Meta-analysis. Obes Surg 2020; 30:4091-4100. [PMID: 32761319 DOI: 10.1007/s11695-020-04860-2] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/13/2020] [Revised: 07/08/2020] [Accepted: 07/11/2020] [Indexed: 02/08/2023]
Abstract
Quality of life and mental health are important outcomes of bariatric therapy. This review aimed to determine endoscopic bariatric procedures' impact on postprocedural quality of life and mental health. Four electronic databases were systematically searched. Studies with adults > 18 years who underwent an endoscopic bariatric procedure and reported pre- and postprocedural quality of life and/or mental health using a validated tool were included. Meta-analyses were conducted using RevMan and study quality was assessed. Twenty studies evaluating five different endoscopic procedures were included (N = 876 total sample size). Intragastric balloon placement was associated with a large improvement in postprocedural quality of life and mental health. Endoscopic bariatric therapies may improve short-term quality of life and mental health alongside weight loss and comorbidity improvement.
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Kahan S, Saunders KH, Kaplan LM. Combining obesity pharmacotherapy with endoscopic bariatric and metabolic therapies. ACTA ACUST UNITED AC 2020. [DOI: 10.1016/j.tige.2020.05.002] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
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Abstract
Obesity poses a significant health care concern in the United States, with 39.8% of adults being classified as obese. Several different methods have been introduced to combat obesity, from medical therapy to surgical options. Bariatric surgery has been demonstrated to be superior to medical therapy alone for weight loss in obese patients. Despite this information, only about 1% of eligible patients undergo bariatric surgery per year. The reason for this treatment gap is multifactorial, but patient apprehension to undergo surgery is a major driving force. Many patients perceive bariatric surgery as dangerous, and believe that living with their current weight is safer than undergoing surgery. To combat this treatment gap, endoscopic therapies have been developed to reach more patients in a less invasive way. This article will review endoscopic treatment options currently available and approved by the Food and Drug Administration, as well as other treatment modalities that are currently in development.
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Affiliation(s)
- Leena Khaitan
- University Hospitals Cleveland Medical Center, Department of Surgery, Cleveland, OH
| | - Brian Shea
- University Hospitals Cleveland Medical Center, Department of Surgery, Cleveland, OH.
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Wojciechowska-Kulik A, Blus E, Kowalczyk Z, Baj Z, Majewska E. The Effect of Noninvasive Bariatric Surgery on the Levels of Certain Adipokines and Atherosclerosis Risk Factors in Patients with Metabolic Syndrome. J Am Coll Nutr 2019; 39:481-487. [DOI: 10.1080/07315724.2019.1695017] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/13/2023]
Affiliation(s)
| | - Edyta Blus
- Department of Pathophysiology and Clinical Immunology, Medical University of Lodz, Lodz, Poland
| | | | - Zbigniew Baj
- Department of Pathophysiology and Clinical Immunology, Medical University of Lodz, Lodz, Poland
| | - Ewa Majewska
- Department of Pathophysiology and Clinical Immunology, Medical University of Lodz, Lodz, Poland
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The Impact of Dietician Support and Behavioural Therapy in Addition to Concomitant Treatment with Intragastric Balloon in Obese Patients. Obes Surg 2019; 30:612-617. [PMID: 31650406 DOI: 10.1007/s11695-019-04228-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/25/2022]
Abstract
INTRODUCTION AND AIMS Patients treated with intragastric balloon (IGB) may benefit from treatment and follow-up by a multidisciplinary team, where the dietician is considered the only essential professional besides the endoscopist. The aim of this study is to evaluate the impact of dietician support and behavioral therapy in terms of weight loss in patients concomitantly treated with IGB while the device is in situ. METHODS Patients with IGB in situ, in period 2005-2018, were invited to undergo a dietician check-up (DC) every 1.5 months, accompanied by cognitive behavioral therapy. Considering their attendance at the dietician check-ups (DCs), patients were categorized as non-compliant (0 DC), partially compliant (1-2 DCs), and highly compliant (≥ 3 DCs). A comparison was made among the three groups regarding % of total body weight loss (%TBWL) and ΔBMI at 180 ± 15 days when the IGB was in situ. RESULTS One hundred eighty-three obese patients treated with fluid-filled IGB were included. Body weight data at 180 ± 15 days during the IGB in situ, as well as attendance at the DCs, were available for 170 out of 183 patients. There was no difference among compliant, partially compliant, and non-compliant patients to DCs regarding %TBWL at 180 ± 15 days (p = 0.17). However, non-compliant patients had a higher ΔBMI at 180 ± 15 days in comparison to those compliant or partially compliant to DCs (p = 0.03). CONCLUSION Despite its undisputed educational role, attendance at DCs does not seem to correlate with an additional weight loss while the IGB is in situ.
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Fluid-Filled Versus Gas-Filled Intragastric Balloons as Obesity Interventions: a Network Meta-analysis of Randomized Trials. Obes Surg 2019; 28:2617-2625. [PMID: 29663250 DOI: 10.1007/s11695-018-3227-7] [Citation(s) in RCA: 40] [Impact Index Per Article: 6.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
BACKGROUND Four commercially available intragastric balloons have been used for the management of obesity and underwent randomized controlled trials (RCTs), and we aimed to compare them using a network meta-analysis approach. METHODS Several databases were queried from inception to May 26, 2017, and we included RCTs enrolling patients treated with Orbera, Heliosphere, ReShape Duo, and Obalon compared with another balloon, sham, or open-label control group. Two investigators independently abstracted data. A random effects frequentist network meta-analysis and relative ranking of agents using surface under the cumulative ranking probabilities were performed. RESULTS We included 15 trials at low risk of bias (only two were head-to-head). Compared to control groups, the two fluid-filled devices were associated with significant outcome (% total body weight loss) at 6 months: Orbera, 6.72% (95% CI, 5.55, 7.89) and ReShape Duo 4% (95% CI 2.69, 5.31). Only one of the two gas-filled devices was associated with significant outcome at 6 months: Obalon 3.3% (95% CI 2.30, 4.30), and not the second: Heliosphere 6.71% (95% CI - 0.82, 14.23). Fluid-filled devices had the highest likelihood of superiority in achieving the outcome at 6 months (96.8%) and at 12 months (96.6%). The quality of evidence was high for comparisons against control. CONCLUSIONS Fluid-filled balloons are more likely to produce weight loss compared to gas-filled balloons or lifestyle intervention. However, they may be associated with a higher rate of intolerance and early removal. This information will aid clinicians in device selection and engaging patients in shared decision-making.
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Displacement of the Intragastric Balloon from the Fundus to the Antrum Results in Enhanced Weight Loss. Obes Surg 2019; 28:2374-2378. [PMID: 29504052 DOI: 10.1007/s11695-018-3168-1] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/26/2022]
Abstract
BACKGROUND The BioEnterics Intragastric Balloon [BIB] is a reliable, non-invasive technique to manage obesity for subjects who refuse or are unsuitable for bariatric surgery. In a prior study, BIB placed in the antrum [A] was found to have significantly better results on weight loss in relation to that in fundus [F], but many balloons initially placed in the F were eventually found in the A. The aim of the present analysis was to evaluate whether the balloon position [firmly in F, firmly in A, or transient from F to A [FA]] influences the 3- and 6-month weight loss. MATERIAL Six hundred sixty-eight patients that underwent successful BIB treatment were assigned into three groups: group F [n = 354], group A [n = 159], and group AF [n = 155]. Weight loss parameters were recorded and analyzed at 3 and 6 months. RESULTS In all three groups, there was a significant, progressive reduction of BMI at 3 and 6 months. At 6 months, BMI reduction between groups F and A, and F and FA [p = 0.001] and groups A and FA [p = 0.018] was prominent. CONCLUSION The position of the BIB affects its effectiveness: better results when antrum is involved. This observation seems to give a great perspective to newly established gastric space-occupying devices, which aim to have a compartment constantly present in the antrum. However, further studies have to be performed in order to validate the results and more importantly to clarify the mechanisms implied.
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Albert Pérez E, Poveda González M, Martínez-Espinosa RM, Molina Vila MD, Reig García-Galbis M. Practical Guidance for Interventions in Adults with Metabolic Syndrome: Diet and Exercise vs. Changes in Body Composition. INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH 2019; 16:E3481. [PMID: 31540536 PMCID: PMC6765968 DOI: 10.3390/ijerph16183481] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 05/30/2019] [Revised: 08/29/2019] [Accepted: 09/02/2019] [Indexed: 12/12/2022]
Abstract
(1) Objective: to establish practical guidance for the design of future clinical trials in MS (metabolic syndrome) patients aged 18 and older, based on a systematic review of randomized clinical trials connecting diet, physical exercise and changes in body composition. (2) Method: this systematic review of randomized clinical trials (RCT) is based on the guidelines recommended by PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses). Criteria of selection: ≥18 years of age; patients diagnosed with MS; intervention programs including diet, physical exercise and/or modifications in the style of life as treatment, as well as the magnitude of changes in body composition (BC); randomized clinical trial published between 2004 and 2018. (3) Results: the multidisciplinary interventions describe major changes in BC, and the recurring pattern in these clinical trials is an energy reduction and control in the percentage of intake of macronutrients along with the performance of regularly structured exercise; the most analyzed parameter was waist circumference (88.9% of the trials), followed by body weight (85.2%), BMI (77.8%) and body fat (55.6%). (4) Conclusions: The analysis of the information here reported sheds light for the design of future clinical trials in adults with MS. The best anthropometric parameters and units of measurement to monitor the interventions are related to dietary and physical exercise interventions. A list of practical advice that is easy to implement in daily practice in consultation is here proposed in order to guarantee the best results in changes of body composition.
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Affiliation(s)
- Enrique Albert Pérez
- Faculty of Health Sciences, University of Alicante, 03690 Alicante, Spain; (E.A.P.); (M.P.G.)
| | - Marina Poveda González
- Faculty of Health Sciences, University of Alicante, 03690 Alicante, Spain; (E.A.P.); (M.P.G.)
| | - Rosa María Martínez-Espinosa
- Division of Biochemistry and Molecular Biology, Department of Agrochemistry and Biochemistry, Faculty of Sciences. University of Alicante, 03690 Alicante, Spain;
| | - Mariola D Molina Vila
- Department of Mathematics, Faculty of Sciences, University of Alicante, 03690 Alicante, Spain;
| | - Manuel Reig García-Galbis
- Department of Nutrition and Dietetics, Faculty of Health Sciences, University of Atacama, Avda. Copayapu 2862, III Region, Copiapó 1530000, Chile
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Abstract
Intragastric balloons (IGBs) are the most widely available endoscopic bariatric therapy for class I and II obesity in the United States. Although simple in application and reversible by nature, these devices may help patients initiate the important first steps in weight loss maintenance, provided that parallel efforts are in motion to prevent weight recidivism. Too often, therapeutic nihilism stems from unrealistic expectations of a given therapy. In the case of IGBs, this sentiment may occur when these interventions are applied in a vacuum and not within the purview of a multidisciplinary program that actively involves dieticians, endocrinologists, gastroenterologists, and surgeons. There is a clear and present need to apply different tactics in the remissive strategy to control the obesity pandemic, more so in a struggling landscape of an ever-widening gap in bridging interventions. With such demand, the IGB is an available tool that could be helpful when correctly implemented. In this exposition, we summarize the current state of IGBs available worldwide, discuss their mechanism of action, relay evidence for their short- and long-term efficacy, address safety profile concerns, and suggest procedural considerations in the real-world quotidian application.
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Finkelstein EA, Verghese NR. Incremental cost-effectiveness of evidence-based non-surgical weight loss strategies. Clin Obes 2019; 9:e12294. [PMID: 30677252 DOI: 10.1111/cob.12294] [Citation(s) in RCA: 20] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/04/2018] [Revised: 12/13/2018] [Accepted: 12/19/2018] [Indexed: 11/29/2022]
Abstract
Recent medical advancements have led to new modes of treatment for non-surgical weight loss, including several new medications. Our aim was to conduct an incremental cost-effectiveness analysis for all commercially available, evidence-based non-surgical weight loss interventions for people with excess weight. We identified interventions through a systematic review of randomized controlled trials that reported weight loss 12 months from baseline. We then meta-analysed the results, sourced costs and performed an incremental cost-effectiveness analysis from the payer perspective. Cost-effectiveness was presented in terms of cost per kilogram lost and quality-adjusted life years (QALY) gained. We further performed sensitivity analyses on costs and duration of benefits, and a probabilistic sensitivity analysis. Ten interventions were identified for inclusion: six pharmaceutical products (Alli, Xenical, Qsymia, Contrave, Belviq and Saxenda), two lifestyle modification programmes (Weight Watchers Meetings and Online), one food replacement and lifestyle programme (Jenny Craig) and one intragastric balloon system (Orbera). At an incremental cost-effectiveness ratio of $30 071 per additional QALY gained, only Weight Watchers Meetings was cost-effective. Sensitivity analyses revealed that for the medications to become incrementally cost-effective, costs would have to decrease by as much as 91%. Results are highly dependent on duration that benefits are maintained. Despite several newly available interventions, Weight Watchers Meetings is currently the only evidence-based, commercially available, cost-effective option for non-surgical weight loss. Other interventions, specifically medications, are more effective but priced too high to be cost-effective.
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Affiliation(s)
- Eric A Finkelstein
- Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore
- Global Health Institute, Duke University, Durham, North Carolina
| | - Naina R Verghese
- Health Services and Systems Research, Duke-NUS Medical School, Singapore, Singapore
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Espinet Coll E, López-Nava Breviere G, Nebreda Durán J, Marra-López Valenciano C, Turró Arau R, Esteban López-Jamar JM, Muñoz-Navas M. Spanish consensus document on bariatric endoscopy. Part 2: specific endoscopic treatments. REVISTA ESPANOLA DE ENFERMEDADES DIGESTIVAS 2019; 111:140-154. [PMID: 30654612 DOI: 10.17235/reed.2019.4922/2017] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
Abstract
During the last years we have been witnessing a significant increase in the number and type of bariatric endoscopic techniques: we have different types of balloons, suture systems, injection of substances and malabsorptive prosthesis, etc. Also, some endoscopic revisional procedures for patients with weight regain after bariatric surgery have been incorporated. This makes it necessary to protocolize, position and regularize all these techniques, through a consensus that allows their clinical application with the maximum medical rigor and scientific evidence available.
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Brito HP, Ribeiro IB, de Moura DTH, Bernardo WM, Chaves DM, Kuga R, Maahs ED, Ishida RK, de Moura ETH, de Moura EGH. Video capsule endoscopy vs double-balloon enteroscopy in the diagnosis of small bowel bleeding: A systematic review and meta-analysis. World J Gastrointest Endosc 2018; 10:400-421. [PMID: 30631404 PMCID: PMC6323498 DOI: 10.4253/wjge.v10.i12.400] [Citation(s) in RCA: 24] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/25/2018] [Revised: 08/31/2018] [Accepted: 11/15/2018] [Indexed: 02/06/2023] Open
Abstract
AIM To compare the diagnostic accuracy of video capsule endoscopy (VCE) and double-balloon enteroscopy (DBE) in cases of obscure gastrointestinal bleeding (OGIB) of vascular origin. METHODS MEDLINE (via PubMed), LILACS (via BVS) and Cochrane/CENTRAL virtual databases were searched for studies dated before 2017. We identified prospective and retrospective studies, including observational, cohort, single-blinded and multicenter studies, comparing VCE and DBE for the diagnosis of OGIB, and data of all the vascular sources of bleeding were collected. All patients were subjected to the same gold standard method. Relevant data were then extracted from each included study using a standardized extraction form. We calculated study variables (sensitivity, specificity, prevalence, positive and negative predictive values and accuracy) and performed a meta-analysis using Meta-Disc software. RESULTS In the per-patient analysis, 17 studies (1477 lesions) were included. We identified 3150 exams (1722 VCE and 1428 DBE) in 2043 patients and identified 2248 sources of bleeding, 1467 of which were from vascular lesions. Of these lesions, 864 (58.5%) were diagnosed by VCE, and 613 (41.5%) were diagnosed by DBE. The pretest probability for bleeding of vascular origin was 54.34%. The sensitivity of DBE was 84% (95%CI: 0.82-0.86; heterogeneity: 78.00%), and the specificity was 92% (95%CI: 0.89-0.94; heterogeneity: 92.0%). For DBE, the positive likelihood ratio was 11.29 (95%CI: 4.83-26.40; heterogeneity: 91.6%), and the negative likelihood ratio was 0.20 (95%CI: 0.15-0.27; heterogeneity: 67.3%). Performing DBE after CE increased the diagnostic yield of vascular lesion by 7%, from 83% to 90%. CONCLUSION The diagnostic accuracy of detecting small bowel bleeding from a vascular source is increased with the use of an isolated video capsule endoscope compared with isolated DBE. However, concomitant use increases the detection rate of the bleeding source.
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Affiliation(s)
- Hélcio Pedrosa Brito
- Department of Endoscopy of Clinics Hospital of São Paulo University, São Paulo 05403-00, Brazil
| | - Igor Braga Ribeiro
- Department of Endoscopy of Clinics Hospital of São Paulo University, São Paulo 05403-00, Brazil
| | | | | | - Dalton Marques Chaves
- Department of Endoscopy of Clinics Hospital of São Paulo University, São Paulo 05403-00, Brazil
| | - Rogério Kuga
- Department of Endoscopy of Clinics Hospital of São Paulo University, São Paulo 05403-00, Brazil
| | - Ethan Dwane Maahs
- Molecular and Cell Biology, University of California, California, Berkeley, CA 94720, United States
| | - Robson Kiyoshi Ishida
- Department of Endoscopy of Clinics Hospital of São Paulo University, São Paulo 05403-00, Brazil
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Barrichello Junior SA, Ribeiro IB, Fittipaldi-Fernandez RJ, Hoff AC, de Moura DTH, Minata MK, de Souza TF, Galvão Neto MDP, de Moura EGH. Exclusively endoscopic approach to treating gastric perforation caused by an intragastric balloon: case series and literature review. Endosc Int Open 2018; 6:E1322-E1329. [PMID: 30410952 PMCID: PMC6221813 DOI: 10.1055/a-0743-5520] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/14/2018] [Accepted: 07/31/2018] [Indexed: 12/14/2022] Open
Abstract
Background and study aims Obesity is a serious disease, resulting in significant morbidity and mortality. Intragastric balloons (IGBs) have been in use since the 1980s. After the insertion of an IGB, complications such as migration of the device and even severe gastric perforation can occur, requiring laparoscopic surgery. Here, we report three cases of gastric perforation after IGB insertion. In all three cases, the perforation was successfully repaired through an exclusively endoscopic approach.
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Affiliation(s)
| | - Igor Braga Ribeiro
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas, University of Sao Paulo School of Medicine, São Paulo, Brazil
| | | | | | | | - Mauricio Kazuyoshi Minata
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas, University of Sao Paulo School of Medicine, São Paulo, Brazil
| | - Thiago Ferreira de Souza
- Gastrointestinal Endoscopy Unit, Hospital das Clínicas, University of Sao Paulo School of Medicine, São Paulo, Brazil
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Incidence of nausea and vomiting after intragastric balloon placement in bariatric patients - A systematic review and meta-analysis. Int J Surg 2018; 57:22-29. [PMID: 30031839 DOI: 10.1016/j.ijsu.2018.06.038] [Citation(s) in RCA: 22] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/12/2018] [Revised: 06/22/2018] [Accepted: 06/26/2018] [Indexed: 02/08/2023]
Abstract
OBJECTIVES This systematic review and meta-analysis was performed to examine the rates of nausea and vomiting along with other common side effects reported from different subtypes of intragastric balloons (IGBs) placed in obese adults. METHODS The online databases of Pubmed, Cochrane Database, and Web of Science were searched to include studies conducted from 09/31/2012 to 09/31/2017 in English using keywords to identify articles relevant to this study. Two independent reviewers performed a full text review to ensure quality of studies and report rates of primary end point of interest: nausea and vomiting post IGB placement. RESULTS Ten studies fulfilled the inclusion criteria. The treatment group's sample size comprised of 688 patients and adverse events' sample size comprised of 938 patients. We evaluated rates of nausea and vomiting of four subtypes of IGB systems: Elipse, Obalon, ORBERA, and ReShape and calculated meta-analytic rates based on adverse events' sample size. Total 564 patients reported experiencing nausea which provided a meta-analytic rate of 63.33% (95% CI 61.49%-65.16%), and 507 patients reported experiencing vomiting which resulted in a meta-analytic rate of 55.29% (95% CI 53.59%-56.99%). The ORBERA balloon system had the highest rates of nausea and vomiting compared to other balloon systems. CONCLUSIONS Based on the findings from previous studies scrutinizing side effects of different types of IGB offered on the market, it has been concluded that nausea and vomiting are very common side effects post gastric balloon placement.
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Kumar N, Bazerbachi F, Rustagi T, McCarty TR, Thompson CC, Galvao Neto MP, Zundel N, Wilson EB, Gostout CJ, Abu Dayyeh BK. The Influence of the Orbera Intragastric Balloon Filling Volumes on Weight Loss, Tolerability, and Adverse Events: a Systematic Review and Meta-Analysis. Obes Surg 2018; 27:2272-2278. [PMID: 28285471 DOI: 10.1007/s11695-017-2636-3] [Citation(s) in RCA: 40] [Impact Index Per Article: 5.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/21/2022]
Abstract
BACKGROUND The Orbera intragastric balloon (IGB) has been approved by the US Food and Drug Administration for use in patients with a body mass index (BMI) between 30 and 40 kg/m2 and is in wide use worldwide as a primary and bridge obesity management tool. The balloon filling volume (BFV) ranges between 400 and 700 mL of saline. Our objective was to determine whether there is an association between BFV and clinically relevant endpoints, namely weight loss outcomes, balloon tolerability, and adverse events. METHODS A systematic review of studies investigating the use of the Orbera IGB system for obesity treatment was performed. Data was examined using random effects modelling and meta-regression analyses. RESULTS Forty-four studies (n = 5549 patients) reported BFV and % total body weight loss (TBWL) at 6 months. Pooled %TBWL at 6 months was 13.2% [95% CI 12.3-14.0]. A funnel plot demonstrated a low risk of publication bias. Meta-regression showed no statistically significant association between filling volume and %TBWL at 6 months (p = 0.268). Higher BFV was associated with lower rates of esophagitis (slope = -0.008, p < 0.001) and prosthesis migration (slope = -0.015, p < 0.001). There was no association between BFV and early removal (p = 0.1), gastroesophageal reflux symptom (p = 0.64), or ulcer rates (p = 0.09). CONCLUSIONS No association was observed between Orbera IGB filling volume and weight loss outcomes. Higher volumes appear to be associated with lower migration and esophagitis rates; thus, a balloon filling volume of 600-650 mL is recommended.
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Affiliation(s)
- Nitin Kumar
- Department of Gastroenterology, Brigham and Women's Hospital, Boston, MA, USA
| | | | - Tarun Rustagi
- Department of Gastroenterology, Mayo Clinic, Rochester, MN, USA
| | - Thomas R McCarty
- Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA
| | | | | | - Natan Zundel
- Department of Surgery, Florida International University, Miami, FL, USA
| | - Erik B Wilson
- Department of Surgery, University of Texas, Houston, TX, USA
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Alsabah S, Al Haddad E, Ekrouf S, Almulla A, Al-Subaie S, Al Kendari M. The safety and efficacy of the procedureless intragastric balloon. Surg Obes Relat Dis 2018; 14:311-317. [DOI: 10.1016/j.soard.2017.12.001] [Citation(s) in RCA: 25] [Impact Index Per Article: 3.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/22/2017] [Revised: 11/07/2017] [Accepted: 12/01/2017] [Indexed: 12/14/2022]
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Keren D, Rainis T. Intragastric Balloons for Overweight Populations—1 Year Post Removal. Obes Surg 2018; 28:2368-2373. [DOI: 10.1007/s11695-018-3167-2] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
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Ribeiro da Silva J, Proença L, Rodrigues A, Pinho R, Ponte A, Rodrigues J, Sousa M, Almeida R, Carvalho J. Intragastric Balloon for Obesity Treatment: Safety, Tolerance, and Efficacy. GE-PORTUGUESE JOURNAL OF GASTROENTEROLOGY 2017; 25:236-242. [PMID: 30320162 DOI: 10.1159/000485428] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 08/03/2017] [Revised: 11/14/2017] [Indexed: 12/15/2022]
Abstract
Background Obesity is an increasing worldwide problem associated with a vast number of comorbidities. Decreasing body weight by only 5-10% has been shown to slow and even prevent the onset of obesity-related comorbidities. Between pharmacological therapy and bariatric surgery a great variety of endoscopic techniques are available, the most common being intragastric balloon (IGB). The purpose of this study was to assess the safety, tolerance, and kinetics of IGBs in weight loss. The kinetics of weight loss were evaluated in 2 different contexts and phases: after the IGB's removal and after follow-up that varied between 6 and 12 months. Successful weight loss was defined as ≥10% weight loss after 6-12 months. Methods The study included 51 patients who had undergone Orbera® IGB placement between September 2014 and February 2016. Inclusion criteria were age between 18 and 65 years; body mass index (BMI) 28-35 with severe obesity-related disorders; or BMI 35-40. The IGB was removed 6 months later. All patients were followed for a minimum period of 6-12 months. Results Of 51 patients, 16 were excluded (7 due to intolerance) and 35 patients entered the study, of which 83% were followed for more than 6-12 months. The average weight loss (WL) and % excess WL (%EWL) after 6 months of treatment were 11.94 kg and 42.16%, respectively. At 6-12 months, after removal of the IGB, the mean WL was 8.25 kg and %EWL was 30.27%. Nineteen patients attained a WL of ≥10% the baseline value at IGB removal and 12 maintained their weight below this threshold during the 6-12 following months. Conclusions After temporary IGB implantation in overweight or obese individuals, a WL that was ≥10% of weight at baseline was achieved in 54.3% and sustained at 6-12 months in 41.4% of participants. IGBs are an attractive intermediate option between diet and exercise programs and bariatric surgery. In general, IGB placement is a safe and well-tolerated procedure.
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Affiliation(s)
- Joana Ribeiro da Silva
- Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal
| | - Luísa Proença
- Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal
| | - Adélia Rodrigues
- Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal
| | - Rolando Pinho
- Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal
| | - Ana Ponte
- Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal
| | - Jaime Rodrigues
- Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal
| | - Mafalda Sousa
- Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal
| | - Rita Almeida
- Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal
| | - João Carvalho
- Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho, Vila Nova de Gaia, Portugal
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Yorke E, Switzer NJ, Reso A, Shi X, de Gara C, Birch D, Gill R, Karmali S. Intragastric Balloon for Management of Severe Obesity: a Systematic Review. Obes Surg 2017; 26:2248-2254. [PMID: 27444806 DOI: 10.1007/s11695-016-2307-9] [Citation(s) in RCA: 67] [Impact Index Per Article: 8.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/15/2022]
Abstract
Older models of intragastric balloons (IGBs) had unacceptably high complication rates and inconsequential weight loss. With FDA approval of newer models, we aimed to systematically examine the literature regarding the efficacy of IGB therapy for obesity. A comprehensive electronic database search was completed. Title searching was restricted to the following keywords: bariatric, gastric, gastric bypass, gastric band, sleeve gastrectomy, and intragastric balloon. Twenty-six primary studies (n = 6101) were included. At balloon removal, mean change in weight and BMI were 15.7 ± 5.3 kg and 5.9 ± 1.0 kg/m(2). The most common complications were nausea/vomiting (23.3 %) and abdominal pain (19.9 %). Serious complications were rare: mortality (0.05 %) and gastric perforation (0.1 %). IGBs are associated with marked short-term weight loss with limited serious complications.
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Affiliation(s)
- Ekua Yorke
- Department of Surgery, University of Alberta, Edmonton, Alberta, Canada
| | - Noah Jacob Switzer
- Department of Surgery, University of Alberta, Edmonton, Alberta, Canada. .,2D, Walter C Mackenzie Health Sciences Centre, University of Alberta, 840-112 Street, Edmonton, Alberta, T6G 2B7, Canada.
| | - Artan Reso
- Department of Surgery, University of Calgary, Calgary, Alberta, Canada
| | - Xinhe Shi
- Center for the Advancement of Minimally Invasive Surgery (CAMIS), Royal Alexandria Hospital, Edmonton, Alberta, Canada
| | - Christopher de Gara
- Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.,Center for the Advancement of Minimally Invasive Surgery (CAMIS), Royal Alexandria Hospital, Edmonton, Alberta, Canada
| | - Daniel Birch
- Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.,Center for the Advancement of Minimally Invasive Surgery (CAMIS), Royal Alexandria Hospital, Edmonton, Alberta, Canada
| | - Richdeep Gill
- Department of Surgery, University of Calgary, Calgary, Alberta, Canada
| | - Shahzeer Karmali
- Department of Surgery, University of Alberta, Edmonton, Alberta, Canada.,Department of Surgery, University of Calgary, Calgary, Alberta, Canada
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