1
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Ying L, Butensky S, Ilang-Ying Y, Ghiassi S. Current State of Endoscopic Bariatric Therapies. Surg Clin North Am 2025; 105:159-171. [PMID: 39523071 DOI: 10.1016/j.suc.2024.06.012] [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: 11/16/2024]
Abstract
The obesity epidemic poses a significant global health challenge. Despite proven efficacy, accessibility to bariatric surgery is limited. Endoscopic bariatric therapies offer less invasive alternatives. Reversible space-occupying devices like intragastric balloons are suitable for both primary obesity treatment and bridging to surgery. Restrictive therapies that reduce gastric volume like the primary obesity surgery endoluminal and endoscopic sleeve gastroplasty have shown promising short-term results. Diverting devices such as intestinal liners/barriers or magnet-assisted anastomoses aim to replicate surgical effects with lower risks, though efficacy varies. Finally, endoscopic revisional procedures like transoral outlet reduction address weight regain post-bariatric surgery.
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Affiliation(s)
- Lee Ying
- Department of Surgery, Yale School of Medicine, PO Box 208062, New Haven, CT 06520, USA
| | - Samuel Butensky
- Department of Surgery, Yale School of Medicine, PO Box 208062, New Haven, CT 06520, USA
| | - Ysabel Ilang-Ying
- Department of Gastroenterology, Yale School of Medicine, 333 Cedar Street, New Haven, CT 06510, USA
| | - Saber Ghiassi
- Department of Surgery, Yale School of Medicine, PO Box 208062, New Haven, CT 06520, USA.
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2
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Chen W, Feng J, Dong S, Guo J, Zhou F, Hu S, Hu R, Wang C, Ma Y, Dong Z. Efficacy and safety of duodenal-jejunal bypass liner for obesity and type 2 diabetes: A systematic review and meta-analysis. Obes Rev 2024; 25:e13812. [PMID: 39191438 DOI: 10.1111/obr.13812] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/24/2022] [Revised: 07/18/2024] [Accepted: 07/25/2024] [Indexed: 08/29/2024]
Abstract
This study aimed to evaluate the efficacy and safety of duodenal-jejunal bypass liner (DJBL) for obesity and type 2 diabetes mellitus. A comprehensive search of electronic databases was conducted up to September 15, 2022. Thirty studies involving 1751 patients were included. At 12 months post-implantation, the reduction in body mass index (BMI) was 4.8 kg/m2 (95% CI 4.1, 5.5), with an excess weight loss of 41.3% (95% CI 33.4%,49.2%) and a total weight loss of 13.1% (95% CI 10.1%, 16.0%). Significant decrease was observed in HbA1c and fasting glucose, with a standardized mean difference of - 0.72 (95% CI - 0.95, - 0.48) and - 0.62 (95% CI - 0.82, - 0.42), respectively. However, these improvements in weight loss and glycemic control were only partially sustained after explantation. In situ, DJBL significantly improves blood pressure and lipid levels. The pooled early removal rate was 19%, and the incidence of severe adverse events was 17%, including device migration (6%), gastrointestinal hemorrhage (4%), device obstruction (4%), and hepatic abscess (2%). DJBL offers significant improvement in weight loss and glycemic control, as well as cardiovascular parameters while in situ. Further studies are warranted to better understand the long-term efficacy and safety of DJBL. The benefits of DJBL need to be carefully weighed against the risks in clinical decision-making.
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Affiliation(s)
- Wenhui Chen
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
| | - Jia Feng
- Institute of Biomedicine, Department of Cellular Biology, Jinan University, Guangzhou, China
| | - Shiliang Dong
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
| | - Jie Guo
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
| | - Fuqing Zhou
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
| | - Songhao Hu
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
| | - Ruixiang Hu
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
| | - Cunchuan Wang
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
| | - Yi Ma
- Institute of Biomedicine, Department of Cellular Biology, Jinan University, Guangzhou, China
- Key laboratory of Bioengineering Medicine of Guangdong Province, Jinan University, Guangzhou, China
- The National Demonstration Center for Experimental Education of Life Science and Technology, Jinan University, Guangzhou, China
| | - Zhiyong Dong
- Department of Metabolic and Bariatric Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, China
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3
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Winder JS, Rodriguez JH. Emerging Endoscopic Interventions in Bariatric Surgery. Gastroenterol Clin North Am 2023; 52:681-689. [PMID: 37919020 DOI: 10.1016/j.gtc.2023.09.001] [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: 11/04/2023]
Abstract
Various endoscopic tools and techniques have been developed to treat obesity and its associated weight-related medical conditions. However, many of these endoscopic treatments may be little known or utilized. This article examines the many endoscopic options that have been developed to treat obesity including gastric aspiration devices, incisionless magnetic anastomotic systems, endoluminal bypass barrier sleeves, primary obesity surgery endoluminal, endoscopic sleeve gastroplasty, and duodenal mucosal resurfacing. We review their development, application, efficacy, and the reported literature on their use and results.
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Affiliation(s)
- Joshua S Winder
- Division of Minimally Invasive and Bariatric Surgery, Penn State Milton S. Hershey Medical Center, Hershey, PA, USA
| | - John H Rodriguez
- Department of General Surgery, Cleveland Clinic Abu Dhabi, Al Maryah Island, Abu Dhabi P.O. Box 112412, United Arab Emirates.
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4
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Mauro A, Lusetti F, Scalvini D, Bardone M, De Grazia F, Mazza S, Pozzi L, Ravetta V, Rovedatti L, Sgarlata C, Strada E, Torello Viera F, Veronese L, Olivo Romero DE, Anderloni A. A Comprehensive Review on Bariatric Endoscopy: Where We Are Now and Where We Are Going. MEDICINA (KAUNAS, LITHUANIA) 2023; 59:medicina59030636. [PMID: 36984637 PMCID: PMC10052707 DOI: 10.3390/medicina59030636] [Citation(s) in RCA: 5] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/05/2023] [Revised: 03/14/2023] [Accepted: 03/18/2023] [Indexed: 03/30/2023]
Abstract
Background: Obesity is a chronic disease that impairs quality of life and leads to several comorbidities. When conservative therapies fail, bariatric surgical options such as Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are the most effective therapies to induce persistent weight loss. Over the last two decades, bariatric endoscopy has become a valid alternative to surgery in specific settings. Primary bariatric endoscopic therapies: Restrictive gastric procedures, such as intragastric balloons (IGBs) and endoscopic gastroplasty, have been shown to be effective in inducing weight loss compared to diet modifications alone. Endoscopic gastroplasty is usually superior to IGBs in maintaining weight loss in the long-term period, whereas IGBs have an established role as a bridge-to-surgery approach in severely obese patients. IGBs in a minority of patients could be poorly tolerated and require early removal. More recently, novel endoscopic systems have been developed with the combined purpose of inducing weight loss and improving metabolic conditions. Duodenal mucosal resurfacing demonstrated efficacy in this field in its early trials: significant reduction from baseline of HbA1c values and a modest reduction of body weight were observed. Other endoscopic malabsorptive have been developed but need more evidence. For example, a pivotal trial on duodenojejunal bypasses was stopped due to the high rate of severe adverse events (hepatic abscesses). Optimization of these more recent malabsorptive endoscopic procedures could expand the plethora of bariatric patients that could be treated with the intention of improving their metabolic conditions. Revisional bariatric therapies: Weight regain may occur in up to one third of patients after bariatric surgery. Different endoscopic procedures are currently performed after both RYGB and SG in order to modulate post-surgical anatomy. The application of argon plasma coagulation associated with endoscopic full-thickness suturing systems (APC-TORe) and Re-EndoSleeve have shown to be the most effective endoscopic treatments after RYGB and SG, respectively. Both procedures are usually well tolerated and have a very low risk of stricture. However, APC-TORe may sometimes require more than one session to obtain adequate final results. The aim of this review is to explore all the currently available primary and revisional endoscopic bariatric therapies focusing on their efficacy and safety and their potential application in clinical practice.
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Affiliation(s)
- Aurelio Mauro
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Francesca Lusetti
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
- Specialization School of Diseases of Digestive System Pavia, University of Pavia, 27100 Pavia, Italy
| | - Davide Scalvini
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
- Specialization School of Diseases of Digestive System Pavia, University of Pavia, 27100 Pavia, Italy
| | - Marco Bardone
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Federico De Grazia
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Stefano Mazza
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Lodovica Pozzi
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Valentina Ravetta
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Laura Rovedatti
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Carmelo Sgarlata
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Elena Strada
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Francesca Torello Viera
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Letizia Veronese
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
| | - Daniel Enrique Olivo Romero
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
- Digestive Endoscopy Unit, Hospital Nacional Zacamil, San Salvador 01120, El Salvador
| | - Andrea Anderloni
- Gastroenterology and Endoscopy Unit, Fondazione IRCCS Policlinico San Matteo, 27100 Pavia, Italy
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Albaugh VL, Axelrod C, Belmont KP, Kirwan JP. Physiology Reconfigured: How Does Bariatric Surgery Lead to Diabetes Remission? Endocrinol Metab Clin North Am 2023; 52:49-64. [PMID: 36754497 DOI: 10.1016/j.ecl.2022.06.003] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
Bariatric surgery improves glucose homeostasis and glycemic control in patients with type 2 diabetes. Over the past 20 years, a breadth of studies has been conducted in humans and rodents aimed to identify the regulatory nodes responsible for surgical remission of type 2 diabetes. The review herein discusses central mechanisms of type 2 diabetes remission associated with weight loss and surgical modification of the gastrointestinal tract.
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Affiliation(s)
- Vance L Albaugh
- Metamor Institute, Pennington Biomedical Research Center, 6400 Perkins Road, Baton Rouge, LA 70808, USA; Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, 6400 Perkins Road, Baton Rouge, LA 70808, USA
| | - Christopher Axelrod
- Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, 6400 Perkins Road, Baton Rouge, LA 70808, USA
| | - Kathryn P Belmont
- Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, 6400 Perkins Road, Baton Rouge, LA 70808, USA
| | - John P Kirwan
- Integrative Physiology and Molecular Medicine Laboratory, Pennington Biomedical Research Center, Louisiana State University, 6400 Perkins Road, Baton Rouge, LA 70808, USA.
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Endoscopic Bariatric Treatment with Duodenal-Jejunal Bypass Liner Improves Non-invasive Markers of Non-alcoholic Steatohepatitis. Obes Surg 2022; 32:2495-2503. [PMID: 35713854 PMCID: PMC9273553 DOI: 10.1007/s11695-022-06150-5] [Citation(s) in RCA: 13] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/16/2021] [Revised: 06/07/2022] [Accepted: 06/07/2022] [Indexed: 01/06/2023]
Abstract
Purpose People with obesity often develop non-alcoholic fatty liver disease (NAFLD) and are at high risk of progression to non-alcoholic steatohepatitis (NASH). Few therapies are effective other than bariatric surgery. We therefore analyzed data from duodenal-jejunal bypass liner (DJBL) patients regarding steatosis, fibrosis, and NASH. Methods Consecutive DJBL patients with type 2 diabetes underwent standardized assessments up to device removal at 48 weeks. These included aspartate and alanine transaminase (AST, ALT), controlled attenuation parameter (CAP, for steatosis), and liver stiffness measurement (LSM, for fibrosis). The NAFLD fibrosis score (NFS), fibrosis-4 score (FIB4), and enhanced liver fibrosis (ELF) test were also used to assess fibrosis and the Fibroscan-AST (FAST) score to assess NASH. Mixed models were used and missing data were accounted for with multiple imputation. Results Thirty-two patients (18 female, mean age 55.1, mean BMI 40.2 kg/m2) were included. After 48 weeks, the change compared to baseline with 95% CI was a factor 0.74 (0.65 to 0.84) for AST, 0.63 (0.53 to 0.75) for ALT, and a difference of − 0.21 (− 0.28 to − 0.13) for FAST, all with p < 0.001. Fibrosis based on LSM, NFS, and ELF did not change whereas FIB4 exhibited slight improvement. Eight DJBL were explanted early due to device-related complications and eight complications led to hospitalization. Conclusions One year of DJBL therapy is associated with relevant improvements in non-invasive markers of steatosis and NASH, but not fibrosis, and is accompanied by a substantial number of complications. Given the lack of alternatives, DJBL deserves further attention. Graphical abstract ![]()
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7
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Primary Bariatric Procedures. Dig Dis Sci 2022; 67:1674-1687. [PMID: 35348970 DOI: 10.1007/s10620-022-07393-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 01/04/2022] [Indexed: 12/09/2022]
Abstract
Obesity is pandemic. It is estimated that by 2030, half of the U.S. population will have obesity. Current treatment options for obesity includes lifestyle modification, pharmacotherapy, endoscopic bariatric and metabolic therapy (EBMT) and bariatric surgery. Over the past decades, an increasing number of EBMTs have been developed and become available. As a gastroenterologist, it is therefore important to become familiar with the available EBMTs as well as their safety and efficacy profiles in order to educate and expeditiously refer patients for the appropriate therapy when eligible. This chapter will review currently available and upcoming EBMTs. Details on how the procedures are performed, their mechanisms of action as well as data from pivotal studies will be summarized.
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8
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Chen JH, Yu ZH, Liu QLF, Meng QG, Chen X. Research Progress of Duodenal-Jejunal Bypass Liner in the Treatment of Obesity and Type 2 Diabetes Mellitus. Diabetes Metab Syndr Obes 2022; 15:3319-3327. [PMID: 36329806 PMCID: PMC9624146 DOI: 10.2147/dmso.s382324] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/14/2022] [Accepted: 10/19/2022] [Indexed: 11/06/2022] Open
Abstract
With the development of economy and improvement of people's living standards, the incidence of obesity and type 2 diabetes mellitus (T2DM) has increased significantly and obesity has also become one of the most important risk factors of T2DM. In light of these trends, there have been many ways to take effect in losing weight. However, they also have corresponding deficiencies including inapparent curative effect, complex and incomplete reversible procedures and severe complications. Duodenal-Jejunal Bypass Liner (DJBL), which mimics Roux-en-Y gastric bypass (RYGB), is proved to play a key role in weight loss and control of T2DM. DJBL is reversible, less invasive and is more suitable for the treatment of obesity and T2DM, which is associated with multiple mechanisms, including incretin effect, gastric emptying mechanism, bile acid regulation, intestinal microbiota, inflammatory reaction mechanism and neural mechanism. In our review, we aimed to elaborate DJBL's clinical efficacy, safety and mechanisms in detail.
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Affiliation(s)
- Ji-Hua Chen
- Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
- Tianjin Institute of Digestive Disease, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
| | - Zi-Han Yu
- Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
- Tianjin Institute of Digestive Disease, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
| | - Qin-Ling Fei Liu
- Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
- Tianjin Institute of Digestive Disease, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
| | - Qing-Guo Meng
- Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
- Tianjin Institute of Digestive Disease, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
| | - Xin Chen
- Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
- Tianjin Institute of Digestive Disease, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China
- Correspondence: Xin Chen, Department of Gastroenterology and Hepatology, Tianjin Medical University General Hospital, Tianjin, People’s Republic of China, Email
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9
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Homan M, Kovač J, Orel R, Battelino T, Kotnik P. Relevant Weight Reduction and Reversed Metabolic Co-morbidities Can Be Achieved by Duodenojejunal Bypass Liner in Adolescents with Morbid Obesity. Obes Surg 2021; 30:1001-1010. [PMID: 31758471 DOI: 10.1007/s11695-019-04279-4] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
BACKGROUND Duodenojejunal bypass liner (DJBL) is an endoscopic, reversible bariatric procedure resulting in weight loss and metabolic co-morbidities improvements in the adults. OBJECTIVES To determine safety and effectiveness of 12-month treatment with DJBL in adolescents with severe obesity (BMI > 35 kg/m2) and co-morbidities. METHODS Post-pubertal subjects were treated with DJBL in an open-label, prospective clinical trial (NTC0218393). They were examined at 3 monthly intervals during the 12 months of DJBL treatment and 12 months of follow-up. RESULTS DJBL was successfully placed in 19/22 adolescents (13 females, mean age (95%CI); 17.3 (16.7-17.9) years, BMI-SDS 3.7 (3.6-3.9)). There were no serious device-related adverse effects. Clinically relevant percent total weight loss (%TWL) (mean (95%CI)) 11.4 (7.4-15.3) % and BMI decrease - 4.9 (- 2.4 to - 7.4) kg/m2 was observed at DJBL removal (n = 19). At 12 months after device removal, %TWL was 4.1 (- 2.6-10.8) % and BMI decrease - 2.6 (0.2 to - 5.4) kg/m2 when compared with values at baseline (n = 13). HOMA-IR (- 2.1 (- 3 to - 1.3), WBISI 1.15 (0.23 to 2.07), total cholesterol, LDL-c, and triglycerides levels also improved during DJBL treatment and relapsed similarly to weight at 12-month follow-up. A decrease in iron stores, Zn, and Se levels was determined during DJBL treatment and spontaneously improved at follow-up. CONCLUSIONS Twelve months of DJBL treatment was safe and effective in adolescents with morbid obesity. Weight regain following device removal and relapse of metabolic complications should be expected.
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Affiliation(s)
- Matjaž Homan
- Department of Gastroenterology, Hepatology and Nutrition, University Children's hospital, University Medical Center Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia. .,Department of Pediatrics, Faculty of Medicine, University of Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia.
| | - Jernej Kovač
- Unit of Special Laboratory Diagnostics, University Children's Hospital, University Medical Center Ljubljana, Vrazov trg 1, SI-1000, Ljubljana, Slovenia
| | - Rok Orel
- Department of Gastroenterology, Hepatology and Nutrition, University Children's hospital, University Medical Center Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia.,Department of Pediatrics, Faculty of Medicine, University of Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia
| | - Tadej Battelino
- Department of Pediatrics, Faculty of Medicine, University of Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia.,Department of Endocrinology, Diabetes And Metabolism, University Children's Hospital, University Medical Center Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia
| | - Primož Kotnik
- Department of Pediatrics, Faculty of Medicine, University of Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia.,Department of Endocrinology, Diabetes And Metabolism, University Children's Hospital, University Medical Center Ljubljana, Bohoričeva 20, SI-1000, Ljubljana, Slovenia
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10
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Winder JS, Rodriguez JH. Emerging Endoscopic Interventions in Bariatric Surgery. Surg Clin North Am 2021; 101:373-379. [PMID: 33743975 DOI: 10.1016/j.suc.2020.12.002] [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: 11/27/2022]
Abstract
Although obesity rates are growing across the world, endoscopic modalities to treat obesity and its metabolic consequences are advancing rapidly. Multiple devices and techniques dedicated to weight management are being developed and have either been approved for use or are undergoing clinical trial. This article reviews many of these endoscopic interventions in bariatric surgery, including gastric aspiration devices, incisionless magnetic anastomotic systems, endoluminal bypass barrier sleeves, primary surgery obesity endoluminal, endoscopic sleeve gastroplasty, and duodenal mucosal resurfacing. These effective techniques may serve either as a primary therapy or as a bridge to bariatric surgery.
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Affiliation(s)
- Joshua S Winder
- Section of Surgical Endoscopy, Department of General Surgery, Cleveland Clinic Lerner College of Medicine, 9500 Euclid Avenue, Mail Code A-100, Cleveland, OH 44195, USA
| | - John H Rodriguez
- Section of Surgical Endoscopy, Department of General Surgery, Cleveland Clinic Lerner College of Medicine, 9500 Euclid Avenue, Mail Code A-100, Cleveland, OH 44195, USA.
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11
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Goyal H, Kopel J, Perisetti A, Mann R, Ali A, Tharian B, Saligram S, Inamdar S. Endobariatric procedures for obesity: clinical indications and available options. Ther Adv Gastrointest Endosc 2021; 14:2631774520984627. [PMID: 33629061 PMCID: PMC7841245 DOI: 10.1177/2631774520984627] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/29/2020] [Accepted: 12/03/2020] [Indexed: 12/18/2022] Open
Abstract
Obesity remains a growing public health epidemic that has increased healthcare costs and related comorbidities. Current treatment guidelines encourage a multidisciplinary approach starting from patient selection, interventions, and long-term follow-up to maintain weight loss. However, these conservative interventions are largely ineffective at reducing body weight due to low adherence to the treatment regimen. Recently, endoscopic bariatric therapies have become an attractive alternative to traditional invasive bariatric surgeries due to their improved efficacy, safety, and cost-effectiveness. Endoscopic bariatric therapies include intragastric balloon placement, endoscopic sleeve gastroplasty, gastric bypass revision, and aspiration therapy. These procedures fall into two separate categories depending on the primary mechanism involved: restrictive or malabsorptive. Restrictive methods, such as the Orbera® and ReShape™ intragastric balloons, increase satiation and delay gastric emptying while decreasing the amount of food that can be ingested. In contrast, malabsorptive devices, such as the EndoBarrier®, interfere with the small intestine's ability to absorb food while restoring normal gastrointestinal hormone levels regulating satiation. Together, these techniques provide useful alternatives for patients in whom pharmacological or lifestyle modifications have proven ineffective. Despite these advantages, the long-term effects of these procedures on metabolic changes remain to be studied. Furthermore, the management of complications from these procedures continues to evolve. In this review, we aim to elaborate on the clinical indications and efficacy of the endobariatric procedures, together with various types of available endoscopic bariatric therapy procedures.
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Affiliation(s)
- Hemant Goyal
- The Wright Center for Graduate Medical
Education, 501 South Washington Avenue, Scranton, PA 18505, USA
| | - Jonathan Kopel
- Department of Medicine, Texas Tech University
Health Sciences Center, Lubbock, TX, USA
| | - Abhilash Perisetti
- Department of Gastroenterology and Hepatology,
University of Arkansas for Medical Sciences, Little Rock, AR, USA
| | - Rupinder Mann
- Department of Internal Medicine, Saint Agnes
Medical Center, Fresno, CA, USA
| | - Aman Ali
- The Commonwealth Medical College, Wilkes Barre
General Hospital, Wilkes-Barre, PA, USA
| | - Benjamin Tharian
- University of Arkansas for Medical Sciences,
Little Rock, AR, USA
| | - Shreyas Saligram
- Division of Advanced Endoscopy,
Gastroenterology, Hepatology, and Nutrition, Department of Medicine,
University of Texas Health San Antonio, San Antonio, TX, USA
| | - Sumant Inamdar
- University of Arkansas for Medical Sciences,
Little Rock, AR, USA
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12
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Tawadros A, Makar M, Kahaleh M, Sarkar A. Overview of bariatric and metabolic endoscopy interventions. Ther Adv Gastrointest Endosc 2020; 13:2631774520935239. [PMID: 32964206 PMCID: PMC7488893 DOI: 10.1177/2631774520935239] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/15/2020] [Accepted: 05/15/2020] [Indexed: 01/11/2023] Open
Abstract
The rise of endoscopic techniques allowing weight loss offers an attractive alternative to surgical interventions in Western countries where the obesity epidemic has risen dramatically. Endoscopists are well positioned to manage obesity given their broad-based medical knowledge, understanding of gastrointestinal physiology, and training in endoscopic technique. The field of bariatric and metabolic endoscopy has permitted the development of several efficacious and safe technologies. This review focuses on techniques and devices used for endoscopic management of obesity, as well as the fundamental justifications to offer those therapies to obese patients.
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Affiliation(s)
- Augustine Tawadros
- Department of Internal Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA
| | - Michael Makar
- Department of Internal Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA
| | - Michel Kahaleh
- Department of Internal Medicine, Division of Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA
| | - Avik Sarkar
- Department of Internal Medicine, Division of Gastroenterology, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA
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Condello G, Chen CY. Minireview: Current status of endoscopic duodenal mucosal resurfacing. Obes Res Clin Pract 2020; 14:504-507. [PMID: 32952067 DOI: 10.1016/j.orcp.2020.09.001] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/23/2020] [Revised: 06/01/2020] [Accepted: 09/02/2020] [Indexed: 11/18/2022]
Abstract
Several strategies are being pursued to overcome the alarming pandemics of obesity and type 2 diabetes (T2D). In recent years, duodenal mucosal resurfacing (DMR) has shown its potential to improve glycemic indices. Following animal studies, which demonstrated feasibility and safety, the procedure has been applied in two human studies. The DMR procedure has been considered feasible and safe in humans with a limited occurrence of complications and adverse events. Reductions in glycated haemoglobin, weight, fasting plasma glucose, and alanine transaminase have been proven at different follow-up time-points. The length of the ablation may induce different outcomes, having the patients with long duodenal segment ablated showed greater beneficial effects. The current evidence does not still prove the apparent insulin-sensitizing mechanism explaining the impact of the DMR procedure on hepatic glucose production. However, the initial findings have demonstrated a positive risk-benefit ratio and an effect on the treatment of metabolic diseases, such as T2D. Future studies should clarify the mechanisms underlying the positive effects and durability of the treatment using controlled trial conditions on larger number of patients.
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Affiliation(s)
- Giancarlo Condello
- Graduate Institute of Sports Training, Institute of Sports Sciences, University of Taipei, Taipei, Taiwan
| | - Chih-Yen Chen
- Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Faculty of Medicine and Institute of Emergency and Critical Medicine, National Yang-Ming University School of Medicine, Taipei, Taiwan; Institutional Review Board, Taipei Veterans General Hospital, Taipei, Taiwan; Taiwan Association for the Study of Small Intestinal Diseases, Guishan, Taoyuan, Taiwan; Chinese Taipei Society for the Study of Obesity, Taipei, Taiwan; World Health Organization-Strategic Initiative for Developing Capacity in Ethical Review/Forum for Ethical Review Committees in the Asian and Western Pacific Region, Pathumthani, Thailand.
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14
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Castro M, Guerron AD. Bariatric endoscopy: current primary therapies and endoscopic management of complications and other related conditions. MINI-INVASIVE SURGERY 2020. [DOI: 10.20517/2574-1225.2020.14] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 01/03/2025]
Abstract
The steady increase in bariatric surgery has led to room for innovation. Endoscopy has become an important tool for evaluation, diagnosis, management of complications, and even for primary bariatric interventions. Leaks are the most feared complication and new endoscopic therapies have been developed such as septotomy, double-pigtail stents, and endoscopic vacuum therapy. Additionally, primary bariatric endoscopic procedures are gaining popularity and the new procedures include intragastric balloons, stoma reduction, aspiration therapy, among others. The altered anatomy and reoperation increase the risk of complications after bariatric surgery, especially when managing conditions like achalasia, gastroparesis, and cholelithiasis. Per-oral endoscopic myotomy, per-oral pyloromyotomy, and endoscopic ultrasound-guided transgastric endoscopic retrograde cholangiopancreatography provide a less invasive approach to address these conditions. This narrative review article intends to expose current endoscopic therapies for the management of primary bariatric procedures, complications and related conditions.
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15
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Colás A, Varela M, Mraz M, Novak D, Cuesta-Frau D, Vigil L, Benes M, Pelikanova T, Haluzik M, Burda V, Vargas B. Influence of glucometric 'dynamical' variables on duodenal-jejunal bypass liner (DJBL) anthropometric and metabolic outcomes. Diabetes Metab Res Rev 2020; 36:e3287. [PMID: 31916665 DOI: 10.1002/dmrr.3287] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/17/2018] [Revised: 11/19/2019] [Accepted: 12/30/2019] [Indexed: 12/23/2022]
Abstract
BACKGROUND The endoscopically implanted duodenal-jejunal bypass liner (DJBL) is an attractive alternative to bariatric surgery for obese diabetic patients. This article aims to study dynamical aspects of the glycaemic profile that may influence DJBL effects. METHODS Thirty patients underwent DJBL implantation and were followed for 10 months. Continuous glucose monitoring (CGM) was performed before implantation and at month 10. Dynamical variables from CGM were measured: coefficient of variation of glycaemia, mean amplitude of glycaemic excursions (MAGE), detrended fluctuation analysis (DFA), % of time with glycaemia under 6.1 mmol/L (TU6.1), area over 7.8 mmol/L (AO7.8) and time in range. We analysed the correlation between changes in both anthropometric (body mass index, BMI and waist circumference) and metabolic (fasting blood glucose, FBG and HbA1c) variables and dynamical CGM-derived metrics and searched for variables in the basal CGM that could predict successful outcomes. RESULTS There was a poor correlation between anthropometric and metabolic outcomes. There was a strong correlation between anthropometric changes and changes in glycaemic tonic control (∆BMI-∆TU6.1: rho = - 0.67, P < .01) and between metabolic outcomes and glycaemic phasic control (∆FBG-∆AO7.8: r = .60, P < .01). Basal AO7.8 was a powerful predictor of successful metabolic outcome (0.85 in patients with AO7.8 above the median vs 0.31 in patients with AO7.8 below the median: Chi-squared = 5.67, P = .02). CONCLUSIONS In our population, anthropometric outcomes of DJBL correlate with improvement in tonic control of glycaemia, while metabolic outcomes correlate preferentially with improvement in phasic control. Assessment of basal phasic control may help in candidate profiling for DJBL implantation.
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Affiliation(s)
- Ana Colás
- Department of Internal Medicine, Hospital Universitario 12 de Octubre, Madrid, Spain
| | - Manuel Varela
- Department of Internal Medicine, Hospital Universitario de Móstoles, Madrid, Spain
| | - Milos Mraz
- Department of Diabetes, Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
- Department of Medical Biochemistry and Laboratory Diagnostics, 1st Faculty of Medicine and General University Hospital, Charles University, Prague, Czech Republic
| | - Daniel Novak
- Department of Cybernetics, Czech Technical University in Prague, Prague, Czech Republic
| | - David Cuesta-Frau
- Technological Institute of Informatics, Universitat Politècnica de València, Alcoi, Spain
| | - Luis Vigil
- Department of Internal Medicine, Hospital Universitario de Móstoles, Madrid, Spain
| | - Marek Benes
- Hepatogastroenterology Department, Transplantation Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
| | - Terezie Pelikanova
- Department of Diabetes, Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
| | - Martin Haluzik
- Department of Diabetes, Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
- Department of Medical Biochemistry and Laboratory Diagnostics, 1st Faculty of Medicine and General University Hospital, Charles University, Prague, Czech Republic
- Laboratory of Experimental Diabetology, Experimental Medicine Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
| | - Vaclav Burda
- Department of Cybernetics, Czech Technical University in Prague, Prague, Czech Republic
| | - Borja Vargas
- Department of Internal Medicine, Hospital Universitario de Móstoles, Madrid, Spain
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Hsu WH, Chang HM, Lee YL, Prasannan A, Hu CC, Wang JS, Lai JY, Yang JM, Jebaranjitham N, Tsai HC. Biodegradable polymer-nanoclay composites as intestinal sleeve implants installed in digestive tract for obesity and type 2 diabetes treatment. MATERIALS SCIENCE & ENGINEERING. C, MATERIALS FOR BIOLOGICAL APPLICATIONS 2020; 110:110676. [PMID: 32204104 DOI: 10.1016/j.msec.2020.110676] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 10/04/2019] [Revised: 01/13/2020] [Accepted: 01/17/2020] [Indexed: 02/07/2023]
Abstract
Obesity and type 2 diabetes have become serious health problems in 21st century. Development of non-invasive treatment to treat obesity and type-2 diabetes is still unmet needs. For targeting on this, one of the promising treatments is to implant an intestine sleeve in the gastrointestinal tract for limitation of food absorption. In this context, biodegradable polymer intestine sleeve was composed of polycaprolactone (PCL), poly-DL-lactic acid (PDLLA) and disk-shape nano-clay (Laponite®), and fabricated as an implantable device. Here, Laponite® as a rheological additive to improve the compatibility of PCL and PDLLA, and the polymers/clay composites were also evaluated by scanning electron microscopy SEM analysis and mechanical measurements. The mass ratio 90/10/1 of PCL/PDLLA/Laponite® composite was selected for fabrication of intestine sleeve, because of the highest toughness and flexibility, which are tensile strength of 91.9 N/mm2 and tensile strain of 448% at the failure point. The prepared intestine sleeve was implanted and deployed at the duodenum in type2 diabetic rats, providing significant benefits in control of the body weight and blood glucose, while compared with the non-implanted type 2 diabetic rats. More importantly, the food intake records and histopathological section reports presented that the implanted rats still have normal appetites and no noticeable acute symptoms of inflammation in the end of the test. These appreciable performances suggested the implantation of biocompatible polymer composites has a highly potential treatment for obesity and type 2 diabetes.
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Affiliation(s)
- Wei-Hsin Hsu
- Graduate Institute of Applied Science and Technology, National Taiwan University of Science and Technology, Taiwan, ROC; Taiwan Instrument Research Institute, National Applied Research Laboratories, Taiwan, ROC
| | - Hao-Ming Chang
- Division of General Surgery, Tri-Service General Hospital, National Defense Medical Center, Taiwan, ROC
| | - Ya-Lun Lee
- Graduate Institute of Applied Science and Technology, National Taiwan University of Science and Technology, Taiwan, ROC
| | - Adhimoorthy Prasannan
- Graduate Institute of Applied Science and Technology, National Taiwan University of Science and Technology, Taiwan, ROC; Advanced Membrane Materials Center, National Taiwan University of Science and Technology, Taiwan, ROC
| | - Chien-Chieh Hu
- Graduate Institute of Applied Science and Technology, National Taiwan University of Science and Technology, Taiwan, ROC; Advanced Membrane Materials Center, National Taiwan University of Science and Technology, Taiwan, ROC; R&D Center for Membrane Technology, Chung Yuan Christian University, Taiwan, ROC
| | - Jun-Sheng Wang
- Taiwan Instrument Research Institute, National Applied Research Laboratories, Taiwan, ROC
| | - Juin-Yih Lai
- Graduate Institute of Applied Science and Technology, National Taiwan University of Science and Technology, Taiwan, ROC; Advanced Membrane Materials Center, National Taiwan University of Science and Technology, Taiwan, ROC; R&D Center for Membrane Technology, Chung Yuan Christian University, Taiwan, ROC
| | - Jen Ming Yang
- Department of Chemical and Materials Engineering, Chang Gung University, Taiwan, ROC; Department of General Dentistry, Chang Gung Memorial Hospital, Taiwan, ROC
| | - Nimita Jebaranjitham
- PG Department of Chemistry, Women's Christian College, (An Autonomous Institution Affiliated to University of Madras), Chennai, India
| | - Hsieh-Chih Tsai
- Graduate Institute of Applied Science and Technology, National Taiwan University of Science and Technology, Taiwan, ROC; Advanced Membrane Materials Center, National Taiwan University of Science and Technology, Taiwan, ROC.
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Brunaldi VO, Ferreira Filho JA, Martone D. Endoscopic Techniques for Obesity and Diabetes. OBESITY AND DIABETES 2020:607-618. [DOI: 10.1007/978-3-030-53370-0_44] [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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18
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Carrano FM, Peev MP, Saunders JK, Melis M, Tognoni V, Di Lorenzo N. The Role of Minimally Invasive and Endoscopic Technologies in Morbid Obesity Treatment: Review and Critical Appraisal of the Current Clinical Practice. Obes Surg 2019; 30:736-752. [DOI: 10.1007/s11695-019-04302-8] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
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19
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Abstract
Background Obesity surgery mortality risk scoring system (OS-MRS) classifies patients into high, intermediate and low risk, based on age, body mass index, sex and other comorbidities such as hypertension and history of pulmonary embolism. High-risk patients not only have a higher mortality but are more likely to develop post-operative complications necessitating intervention or prolonged hospital stay following bariatric surgery. Endoscopically placed duodenal-jejunal bypass sleeve (Endobarrier) has been designed to achieve weight loss and improve glycaemic control in morbidly obese patients with clinically proven effectiveness. The aim of this study was to assess if pre-operative insertion of endobarrier in high-risk patients can decrease morbidity and length of stay after bariatric surgery. Materials and Methods Between 2012 and 2014, a cohort of 11 high-risk patients had an Endobarrier inserted (E&BS group) for 1 year prior to definitive bariatric surgery. These patients were compared against a similar group undergoing primary bariatric surgery (PBS group) during same duration. The two groups were matched for age, gender, body mass index, comorbidities, surgical procedure and OS-MRS using propensity score matching. Outcome measures included operative time, morbidity, length of stay, intensive therapy unit (ITU) stay, readmission rate, percentage excess weight loss (%EWL) and percentage total weight loss (%TWL). Results Patient characteristics and OS-MRS were similar in both groups (match tolerance 0.1). There was no significant difference in total length of stay, readmission rate, %EWL and %TWL. Operative time, ITU stay, post-operative complications and severity of complications were significantly less in the E&BS group (p < 0.05) with significant likelihood of planned ITU admissions in the PBS group (p < 0.05). Conclusion Endobarrier could be considered as a pre bariatric surgical intervention in high-risk patients. It may result in improved post-operative outcomes in high-risk bariatric patients.
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20
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Patel N, Mohanaruban A, Ashrafian H, Le Roux C, Byrne J, Mason J, Hopkins J, Kelly J, Teare J. EndoBarrier®: a Safe and Effective Novel Treatment for Obesity and Type 2 Diabetes? Obes Surg 2019; 28:1980-1989. [PMID: 29450844 PMCID: PMC6018591 DOI: 10.1007/s11695-018-3123-1] [Citation(s) in RCA: 28] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
Background and Aims Obesity associated with diabetes mellitus is a significant worldwide problem associated with considerable health care costs. Whilst surgical intervention is effective, it is invasive, costly and associated with complications. This study aims to evaluate the safety and efficacy of the EndoBarrier®, a duodenal-jejunal sleeve bypass as an alternative treatment of diabetes mellitus in obese patients. Materials and Methods This was a multi-centre, non-randomised trial recruiting obese patients with type 2 diabetes from three sites in the UK. Eligible participants had a BMI of 30–50 kg/m2 and HbA1c levels of 7.5–10%. The study comprised a 12-month period with the EndoBarrier® inserted and a 6-month follow-up period after it had been explanted. The primary study outcomes were weight, BMI, HbA1c levels and fasting insulin and glucose levels. Results Forty-five patients were recruited and 31 patients (69%) completed the 12-month study period. Significant reductions in weight (95%CI 0.62–29.38; p < 0.05) and BMI (95%CI 1.1–8.7; p < 0.005) were documented 12 months after device insertion. The mean HbA1c was significantly reduced (95%CI 0.1–1.6; p < 0.05) after the device insertion period and reductions in metabolic parameters (fasting insulin and glucose levels) were also documented during the study. Adverse events were also assessed in all patients, the vast majority of which were reported as mild. Conclusions The EndoBarrier® appears to be a safe and effective treatment strategy in overweight patients with poor glycaemic control despite medical therapy, or in those who are eligible but decline bariatric surgery.
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Affiliation(s)
- Nisha Patel
- St Mary's Hospital, Imperial College London, Praed Street, London, W2 1NY, UK
| | | | - Hutan Ashrafian
- St Mary's Hospital, Imperial College London, Praed Street, London, W2 1NY, UK
| | - Carel Le Roux
- Metabolic Medicine, Charing Cross Hospital, Imperial College London, Fulham Palace Road, London, W6 8RF, UK
| | - James Byrne
- University Hospital Southampton NHS Foundation Trust, Southampton General Hospital, Tremona Road, Southampton, Hampshire, SO16 6YD, UK
| | - John Mason
- Trafford Hospitals, Central Manchester University Hospitals NHS Foundation Trust, Moorside Road, Davyhulme, Manchester, M41 5SL, UK
| | - James Hopkins
- North Bristol NHS Trust, Southmead Hospital Bristol, Southmead Road, Westbury-on-Trym, Bristol, BS10 5NB, UK
| | - Jamie Kelly
- University Hospital Southampton NHS Foundation Trust, Southampton General Hospital, Tremona Road, Southampton, Hampshire, SO16 6YD, UK
| | - Julian Teare
- St Mary's Hospital, Imperial College London, Praed Street, London, W2 1NY, UK.
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21
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Abstract
PURPOSE OF REVIEW Obesity is increasing at an alarming rate and now poses a global threat to humankind. In recent years, we have seen the emergence of medical devices to combat the obesity epidemic. These therapeutic strategies are discussed in this review dividing them into gastric and duodenal therapies. RECENT FINDINGS Traditionally, medical devices for obesity such as the intragastric balloon have focused on reducing gastric size, but more recently there has been a shift towards developing devices that modulate neural and hormonal responses to induce early satiety thus reducing oral intake. Medical devices for obesity treatment may have a role in those patients who are struggling to control their weight despite significant lifestyle modifications such as diet and exercise and who decline or are unfit for bariatric surgery. For the wider adoption and integration of these devices in the obesity treatment paradigm, more long-term efficacy and safety data from randomised controlled trials are required.
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Affiliation(s)
- Aruchuna Ruban
- Imperial College London, St Mary’s Campus, London, W2 1NY UK
| | - Akash Doshi
- Department of Surgery & Cancer, Homerton University Hospital, London, E9 6SR UK
| | - Erika Lam
- Department of Surgery & Cancer, Homerton University Hospital, London, E9 6SR UK
| | - Julian P. Teare
- Imperial College London, St Mary’s Campus, London, W2 1NY UK
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22
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Frydenberg Am HB, Suturin VM, Truong H, Ryan A, Soutorine M. New Anchoring Mechanism and Design of an Endoluminal Duodeno-Jejunal Bypass Liner for Treatment of Obesity: a Pilot Animal Trial. Obes Surg 2019; 29:3081-3085. [PMID: 31127497 DOI: 10.1007/s11695-019-03945-x] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/28/2022]
Abstract
OBJECTIVE Complications of bleeding, liver abscess and movement have been associated with previous duodeno-jejunal bypass liner (DJBL) applications in the past. A new anchoring system and design of a DJBL is presented as a pilot study. METHOD A newly designed DJBL device was inserted in 2 pigs and observed over 2 months. RESULTS The newly designed device was anchored and monitored for 1 month in 1 of 2 pigs, the other being passed early. Effectiveness and safety have been shown. CONCLUSION The results of this pilot study warrant further investigation of the modified DJBL setup, which may help solve standing issues associated with the clinical use of a DJB liner.
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Affiliation(s)
- Harry B Frydenberg Am
- Epworth Centre for Bariatric Surgery, Suite 2.1, 173 Lennox Street, Richmond, Victoria, 3121, Australia.
| | - Victor M Suturin
- Department of Physiology Metabolism, Diabetes and Obesity Program, Monash Biomedicine Discovery Institute, Monash University, Clayton, Victoria, Australia
| | - Hien Truong
- Epworth Hospital, Richmond, Victoria, Australia
| | - Andrew Ryan
- TissuPath, Mount Waverley, Melbourne, Victoria, Australia
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Abstract
Objective: With the evolution of society and changes in human lifestyle, obesity is becoming increasingly prevalent worldwide, and obesity-related comorbidities such as diabetes, hyperlipidemia, hypertension, and coronary heart disease are more common. As a result, new devices and methods for bariatric and metabolic endoscopy are being developed for clinical use, offering new options for patients. This review discussed the progress in bariatric and metabolic endoscopy. Data Sources: This review was based on data in articles published in the PubMed database up to September 2017, with the following keywords: “obesity”, “endoscopy”, “weight loss”, and “metabolism”. Study Selection: Original articles about various endoscopic methods of weight loss and other reviews of bariatric and metabolic endoscopy were included and analyzed. Results: The technology of bariatric and metabolic endoscopy has advanced rapidly in recent years. The intragastric balloon (IGB), with its comparatively long period of development, is the most mature and widely used instrument. Multiple new endoscopic devices have been created in recent years, with different targets to achieve weight loss. Despite the proliferation of new devices, the lack of clinical data results in a shortage of clinical experience and instruction in the use of this new equipment. Conclusions: Bariatric and metabolic endoscopy would help obese people lose weight or prepare for bariatric surgery and hopefully alleviate some of the complications of bariatric procedures. Adequate studies and data are still needed for the new endoscopic devices.
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Affiliation(s)
- Shi-Han Li
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
| | - Yong-Jun Wang
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
| | - Shu-Tian Zhang
- Department of Gastroenterology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
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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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Mason Hedberg H, Ujiki M. Endoscopic Best Practices. QUALITY IN OBESITY TREATMENT 2019:101-109. [DOI: 10.1007/978-3-030-25173-4_11] [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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Li YX, Fang DH, Liu TX. Laparoscopic sleeve gastrectomy combined with single-anastomosis duodenal-jejunal bypass in the treatment of type 2 diabetes mellitus of patients with body mass index higher than 27.5 kg/m2 but lower than 32.5 kg/m2. Medicine (Baltimore) 2018; 97:e11537. [PMID: 30075520 PMCID: PMC6081088 DOI: 10.1097/md.0000000000011537] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/05/2017] [Accepted: 06/20/2018] [Indexed: 12/25/2022] Open
Abstract
This study aimed to introduce this surgical technique laparoscopic sleeve gastrectomy combined with single-anastomosis duodenal-jejunal bypass (LDJB-LSG), and to confirm this new surgical technique was safe in the treatment of type 2 diabetes mellitus (T2DM) of patients with body mass index (BMI) higher than 27.5 kg/m but lower than 32.5 kg/m.A total of 34 T2DM patients with (BMI) higher than 27.5 kg/m but lower than 32.5 kg/m were admitted to our department between January 2014 and October 2016, of whom 25 received laparoscopic gastric bypass surgery (LRYGB) and 9 received LDJB-LSG. The efficacy and safety were compared between the 2 groups.None in both groups died and had severe postoperative complications. All the surgeries were performed by laparoscopy, and none received switching to open surgery. Patients received regular follow-up after surgery and none were lost to follow-up.Our study indicates LDJB-LSG is similar to LRYGB in the improvements of the body weight, blood glucose, insulin resistance, islet β cell function, blood lipid profile and serum uric acid, and thus LDJB-LSG is applicable in T2DM patients with 27.5 kg/m ≤ BMI ≤ 32.5 kg/m and risk for gastric cancer. However, long-term therapeutic effects need to be evaluated by studies with multicenter, large sample size, and long-term follow-ups.
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Laubner K, Riedel N, Fink K, Holl RW, Welp R, Kempe HP, Lautenbach A, Schlensak M, Stengel R, Eberl T, Dederichs F, Schwacha H, Seufert J, Aberle J. Comparative efficacy and safety of the duodenal-jejunal bypass liner in obese patients with type 2 diabetes mellitus: A case control study. Diabetes Obes Metab 2018; 20:1868-1877. [PMID: 29569313 DOI: 10.1111/dom.13300] [Citation(s) in RCA: 15] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/24/2017] [Revised: 03/15/2018] [Accepted: 03/17/2018] [Indexed: 12/28/2022]
Abstract
AIMS The duodenal-jejunal bypass liner (DJBL) is an endoscopic device mimicking surgical duodenal-jejunal bypass, and is indicated for the treatment of obesity-associated type 2 diabetes mellitus. This analysis was conducted to evaluate the efficacy and safety of the DJBL in comparison to lifestyle changes and antidiabetic drugs. MATERIALS AND METHODS To determine the efficacy and long-term safety of the DJBL, data concerning 235 obese patients with type 2 diabetes mellitus from the German DJBL registry were analysed. For comparison with standard treatment, propensity-score-matching with patients from the German DPV registry, including the matching parameters sex, age, diabetes duration, baseline BMI and baseline HbA1c, was applied. The final matched cohort consisted of 111 patients in the DJBL group and 222 matched control DPV patients. RESULTS Mean treatment time with the DJBL was 47.5 ± 12.2 weeks, mean BMI reduction was 5.0 kg/m2 (P < .001) and mean HbA1c reduction was 1.3% (11.9 mmol/mol) (P < .001). Reduction of antidiabetic medications and improvements in other metabolic and cardiovascular risk parameters was observed. In comparison to the matched control group, mean reductions in HbA1c (-1.37% vs -0.51% [12.6 vs 3.2 mmol/mol]; P < .0001) and BMI (-3.02 kg/m2 vs -0.39 kg/m2 ; P < .0001) were significantly higher. Total cholesterol, LDL cholesterol and blood pressure were also significantly better. CONCLUSION This study provides the largest, so far, hypothesis-generating evidence for a putative positive risk/benefit ratio for treatment of obese patients with type 2 diabetes mellitus with the DJBL as an alternative treatment option for this patient population.
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MESH Headings
- Anastomosis, Surgical/adverse effects
- Bariatric Surgery/adverse effects
- Body Mass Index
- Case-Control Studies
- Cohort Studies
- Diabetes Mellitus, Type 2/blood
- Diabetes Mellitus, Type 2/complications
- Diabetes Mellitus, Type 2/drug therapy
- Diabetes Mellitus, Type 2/therapy
- Drug Therapy, Combination
- Duodenum/surgery
- Endoscopy, Gastrointestinal/adverse effects
- Endoscopy, Gastrointestinal/instrumentation
- Female
- Follow-Up Studies
- Germany
- Humans
- Hyperglycemia/prevention & control
- Hypoglycemic Agents/therapeutic use
- Jejunum/surgery
- Male
- Middle Aged
- Obesity, Morbid/blood
- Obesity, Morbid/complications
- Obesity, Morbid/surgery
- Obesity, Morbid/therapy
- Postoperative Complications/prevention & control
- Prospective Studies
- Registries
- Risk Assessment
- Weight Loss
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Affiliation(s)
- Katharina Laubner
- Division of Endocrinology and Diabetology, Department of Medicine II, Medical Faculty, University Hospital of Freiburg, Freiburg, Germany
| | - Nina Riedel
- Department of Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Hamburg, Germany
| | - Katharina Fink
- Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany
- German Center for Diabetes Research, Munich-Neuherberg, Germany
| | - Reinhard W Holl
- Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm, Germany
- German Center for Diabetes Research, Munich-Neuherberg, Germany
| | - Reinhard Welp
- Clinic for Internal Medicine, Knappschaftskrankenhaus Bottrop, Bottrop, Germany
| | | | - Anne Lautenbach
- Department of Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Hamburg, Germany
| | - Matthias Schlensak
- Department of Surgery, Schön Klinik Düsseldorf SE & Co. KG, Düsseldorf, Germany
| | | | | | - Frank Dederichs
- Department of Internal Medicine/Gastroenterology, Marienhospital Gelsenkirchen, Gelsenkirchen, Germany
- Department of Internal Medicine/Gastroenterology, Kath. Kliniken Hagen, Hagen, Germany
| | - Henning Schwacha
- Department of Medicine II, Medical Center, University of Freiburg, Faculty of Medicine, Freiburg, Germany
| | - Jochen Seufert
- Division of Endocrinology and Diabetology, Department of Medicine II, Medical Faculty, University Hospital of Freiburg, Freiburg, Germany
| | - Jens Aberle
- Department of Endocrinology and Diabetology, University Hospital Hamburg-Eppendorf, Hamburg, Germany
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The EndoBarrier: Duodenal-Jejunal Bypass Liner for Diabetes and Weight Loss. Gastroenterol Res Pract 2018; 2018:7823182. [PMID: 30147720 PMCID: PMC6083488 DOI: 10.1155/2018/7823182] [Citation(s) in RCA: 44] [Impact Index Per Article: 6.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/02/2018] [Accepted: 07/12/2018] [Indexed: 01/11/2023] Open
Abstract
The rapid rise of obesity and type 2 diabetes poses a global threat to healthcare and is a major cause of mortality and morbidity. Bariatric surgery has revolutionised the treatment of both these conditions but is invasive and associated with an increased risk of complications. The EndoBarrier is a device placed endoscopically in the duodenum, which is designed to mimic the effects of gastric bypass surgery with the aim of inducing weight loss and improving glycaemic control. This review outlines the current clinical evidence of the device, its efficacy, potential mechanisms of action, and utility in clinical practice.
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Forner PM, Ramacciotti T, Farey JE, Lord RV. Safety and Effectiveness of an Endoscopically Placed Duodenal-Jejunal Bypass Device (EndoBarrier®): Outcomes in 114 Patients. Obes Surg 2018; 27:3306-3313. [PMID: 29018990 DOI: 10.1007/s11695-017-2939-4] [Citation(s) in RCA: 27] [Impact Index Per Article: 3.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/19/2022]
Abstract
BACKGROUND The duodenal-jejunal bypass liner (DJBL) is an endoscopically placed device designed to achieve weight loss and improve glycemic control in obese patients. Previous studies report promising results but typically included small patient numbers and short follow-up. This study aims to determine the safety and effectiveness of the device. METHODS Study design: A series of all patients treated by the DJBL at our institutions. OUTCOME MEASUREMENTS Weight loss, biochemical measures, complications. RESULTS Between July 2012 and March 2015, 114 consecutive patients were treated for a mean 51.1 weeks (standard deviation (SD) 19.9 weeks). Mean total body weight change from baseline was 12.0 kg (SD 8.5 kg, p < 0.001). Mean percent total body weight loss (%TWL) was 10.5% (SD 7.3%). Mean HbA1c was not significantly improved, but of 10 patients on insulin, 4 ceased insulin and 4 reduced insulin dosages. There was a significant decrease in hemoglobin and total cholesterol and a significant increase in serum alkaline phosphatase. Seventy-four percent of patients experienced at least one adverse event, some of them serious including 6 device obstructions, 5 gastrointestinal hemorrhages, 2 liver abscesses, and 1 acute pancreatitis. Seventy-four percent of patients experienced weight gain after removal with a mean 4.5 ± 6.1 kg (p < 0.0001) within the first 6 months after explantation. CONCLUSIONS The DJBL provides significant but highly variable weight loss. Glycemic control was variable. Most insulin-requiring T2DM patients ceased or reduced insulin. Most patients experience an adverse event and most regain significant weight after device removal. Major adverse events can occur, including the potentially life-threatening complications of hepatic abscess and gastrointestinal hemorrhage.
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Affiliation(s)
- Patrice M Forner
- St. Vincent's Centre for Applied Medical Research, Sydney, Australia
| | - Timothy Ramacciotti
- St. Vincent's Centre for Applied Medical Research and University of New South Wales, Suite 606, 438 Victoria Street, Darlinghurst, Sydney, NSW, 2010, Australia.,Department of Surgery, School of Medicine, University of Notre Dame, Sydney, Australia
| | - John E Farey
- St. Vincent's Centre for Applied Medical Research, Sydney, Australia
| | - Reginald V Lord
- St. Vincent's Centre for Applied Medical Research and University of New South Wales, Suite 606, 438 Victoria Street, Darlinghurst, Sydney, NSW, 2010, Australia. .,Department of Surgery, School of Medicine, University of Notre Dame, Sydney, Australia.
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Glaysher MA, Mohanaruban A, Prechtl CG, Goldstone AP, Miras AD, Lord J, Chhina N, Falaschetti E, Johnson NA, Al-Najim W, Smith C, Li JV, Patel M, Ahmed AR, Moore M, Poulter N, Bloom S, Darzi A, Le Roux C, Byrne JP, Teare JP. A randomised controlled trial of a duodenal-jejunal bypass sleeve device (EndoBarrier) compared with standard medical therapy for the management of obese subjects with type 2 diabetes mellitus. BMJ Open 2017; 7:e018598. [PMID: 29146657 PMCID: PMC5695522 DOI: 10.1136/bmjopen-2017-018598] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
INTRODUCTION The prevalence of obesity and obesity-related diseases, including type 2 diabetes mellitus (T2DM), is increasing. Exclusion of the foregut, as occurs in Roux-en-Y gastric bypass, has a key role in the metabolic improvements that occur following bariatric surgery, which are independent of weight loss. Endoscopically placed duodenal-jejunal bypass sleeve devices, such as the EndoBarrier (GI Dynamics, Lexington, Massachusetts, USA), have been designed to create an impermeable barrier between chyme exiting the stomach and the mucosa of the duodenum and proximal jejunum. The non-surgical and reversible nature of these devices represents an attractive therapeutic option for patients with obesity and T2DM by potentially improving glycaemic control and reducing their weight. METHODS AND ANALYSIS In this multicentre, randomised, controlled, non-blinded trial, male and female patients aged 18-65 years with a body mass index 30-50 kg/m2 and inadequately controlled T2DM on oral antihyperglycaemic medications (glycosylated haemoglobin (HbA1c) 58-97 mmol/mol) will be randomised in a 1:1 ratio to receive either the EndoBarrier device (n=80) for 12 months or conventional medical therapy, diet and exercise (n=80). The primary outcome measure will be a reduction in HbA1c by 20% at 12 months. Secondary outcome measures will include percentage weight loss, change in cardiovascular risk factors and medications, quality of life, cost, quality-adjusted life years accrued and adverse events. Three additional subgroups will investigate the mechanisms behind the effect of the EndoBarrier device, looking at changes in gut hormones, metabolites, bile acids, microbiome, food hedonics and preferences, taste, brain reward system responses to food, eating and addictive behaviours, body fat content, insulin sensitivity, and intestinal tissue gene expression. TRIAL REGISTRATION NUMBER ISRCTN30845205, ClinicalTrials.gov Identifier NCT02459561.
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Affiliation(s)
- Michael Alan Glaysher
- Southampton Biomedical Research Centre, University Hospital Southampton, Southampton, Hampshire, UK
| | | | | | - Anthony P Goldstone
- PsychoNeuroEndocrinology Research Group, Neuropsychopharmacology Unit, Centre for Psychiatry and Computational, Cognitive and Clinical Neuroimaging Laboratory, Division of Brain Sciences, Imperial College London, London, UK
| | - Alexander Dimitri Miras
- Division of Diabetes, Endocrinology and Metabolic Medicine, Hammersmith Hospital, London, UK
| | - Joanne Lord
- Southampton HTA Centre, University of Southampton, University of Southampton Science Park, Southampton, UK
| | - Navpreet Chhina
- Computational Cognitive and Clinical Neuroimaging Group, Hammersmith Hospital, Imperial College London, London, UK
| | | | | | - Werd Al-Najim
- Department of Investigative Medicine, Imperial College London, London, UK
- Diabetes Complications Research Centre, Conway Institute, Dublin, Ireland
- School of Medicine and Medical Sciences, University College Dublin, Dublin, Ireland
| | - Claire Smith
- Imperial Clinical Trials Unit, Imperial College London, London, UK
| | - Jia V Li
- Division of Computational and Systems Medicine, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, London, UK
| | - Mayank Patel
- Department of Diabetes and Endocrinology, Southampton General Hospital, Southampton, UK
| | - Ahmed R Ahmed
- Imperial College Healthcare NHS Trust, St Mary's Hospital, London, UK
| | - Michael Moore
- Primary Care Medical Group, University of Southampton Medical School, Southampton, UK
| | - Neil Poulter
- Imperial Clinical Trials Unit, Imperial College London, London, UK
| | - Stephen Bloom
- North West London Pathology, Head of Division of Diabetes, Endocrinology and Metabolism, Imperial College London, Hammersmith Hospital, London, UK
| | - Ara Darzi
- Division of Surgery, Imperial College London, London, UK
| | - Carel Le Roux
- Head of Pathology, University College Dublin, Dublin, Ireland
| | - James P Byrne
- Division of Surgery, University Hospital Southampton NHS Foundation Trust, Southampton, UK
| | - Julian P Teare
- Department of Gastroenterology, Imperial College Healthcare NHS Trust, St Mary's Hospital, London, UK
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Jirapinyo P, Thompson CC. Endoscopic Bariatric and Metabolic Therapies: Surgical Analogues and Mechanisms of Action. Clin Gastroenterol Hepatol 2017; 15:619-630. [PMID: 27989851 PMCID: PMC5444453 DOI: 10.1016/j.cgh.2016.10.021] [Citation(s) in RCA: 74] [Impact Index Per Article: 9.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/31/2016] [Revised: 10/24/2016] [Accepted: 10/24/2016] [Indexed: 02/07/2023]
Abstract
Obesity is a worsening pandemic with numerous related comorbid illnesses. Conservative management including lifestyle modification and medications have limited efficacy. In contradistinction, bariatric surgery is effective, however, with substantial cost and non-negligible morbidity and mortality. As such, a small percentage of eligible patients undergo surgery. Over the past decade, endoscopic bariatric and metabolic therapies have been introduced as a less invasive option for the treatment of obesity and its related comorbid illnesses. This article reviews major endoscopic bariatric and metabolic therapies, their surgical analogues, and proposed mechanisms of action. Clinical trial data for each device also are discussed.
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32
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Edmundowicz SA. Small Bowel Target Devices and Techniques. Gastrointest Endosc Clin N Am 2017; 27:289-297. [PMID: 28292407 DOI: 10.1016/j.giec.2017.01.001] [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: 02/04/2023]
Abstract
The small bowel is a prime target for bariatric and metabolic endoscopic therapies. New insights into the mechanisms of action of surgical therapies have led to new endoscopic therapies for obesity, type 2 diabetes mellitus, and the metabolic syndrome. The development of endoluminal sleeves that bypass the proximal duodenum have replicated some of the effects of surgical bypass procedures. The endoscopic dual-path enteral bypass has created new and treatment options for these conditions. Duodenal mucosal resurfacing offers significant promise for diabetes management. It is hoped that a durable endoscopic therapy for these conditions will be defined and optimized.
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Affiliation(s)
- Steven A Edmundowicz
- Digestive Health Center, University of Colorado Hospital, University of Colorado School of Medicine, Mail Stop F735, Anschutz Outpatient Pavilion, 1635 Aurora Court, Aurora, CO 80045, USA.
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Lo SK. Duodenal endoscopic interventions for obesity and diabetes. Gastrointest Endosc 2017; 85:416-418. [PMID: 28089035 DOI: 10.1016/j.gie.2016.09.024] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/17/2016] [Accepted: 09/19/2016] [Indexed: 02/08/2023]
Affiliation(s)
- Simon K Lo
- Department of Medicine, Division of Digestive Diseases and Hepatology, Cedars-Sinai Medical Center, David Geffen School of Medicine at UCLA, Los Angeles, California, USA
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Park JM. Role of Malabsorptive Endoscopic Procedures in Obesity Treatment. Clin Endosc 2017; 50:26-30. [PMID: 28147470 PMCID: PMC5299975 DOI: 10.5946/ce.2017.004] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/05/2016] [Revised: 01/08/2017] [Accepted: 01/15/2017] [Indexed: 11/21/2022] Open
Abstract
The incidence of obesity is increasing, and more definitive treatment modalities are needed. Endoluminal procedures, including restrictive endoscopic procedures, endoscopic gastroplasty, and malabsorptive endoscopic procedures, can reduce weight in obese patients and control obesity-related comorbidities. Malabsorptive endoscopic interventions also offer the potential for an ambulatory procedure that may be safer and more cost-effective compared with laparoscopic surgery. Malabsorptive endoscopic intervention can induce weight reduction and improve obesity-related metabolic parameters, despite complications such as device migration, obstruction, and abdominal pain. Improvement in technique will follow the development of new devices.
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Affiliation(s)
- Jae Myung Park
- Division of Gastroenterology, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
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35
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Klobucar Majanovic S, Brozovic B, Stimac D. Bariatric endoscopy: current state of the art, emerging technologies, and challenges. Expert Rev Med Devices 2017; 14:149-159. [PMID: 28081657 DOI: 10.1080/17434440.2017.1281741] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/01/2023]
Abstract
INTRODUCTION Over the last few decades obesity has become a major health issue worldwide. Although dietary and lifestyle changes are the cornerstone of obesity management, it still poses a huge challenge for the majority of patients to permanently change their eating habits. Bariatric endoscopy represents an evolving filed of minimally invasive techniques and procedures for weight loss trying to respond to these challenges by developing new methods with the increasing role of endoscopists in the management of obesity. Areas covered: The aim of this article is to review the role and the advantages of bariatric endoscopy in the management of obesity by providing a comprehensive reference source and evaluating the currently available and emerging endoscopic devices and techniques for weight loss. Expert commentary: Endoscopic methods for weight loss represent a useful armamentarium in the management of obesity by providing improved effectiveness compared with medications, with a lower risk profile than traditional bariatric surgery. Although preliminary results of recently introduced methods are encouraging, many questions remain regarding the safety and efficacy of such interventions. Combining scientific background with advancements in technology is the key strategy for the further development of bariatric endoscopy.
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Affiliation(s)
- Sanja Klobucar Majanovic
- a Department of Internal Medicine, Division of Endocrinology, Diabetes and Metabolic Diseases , University Hospital Rijeka , Croatia , Rijeka
| | - Boris Brozovic
- b Department of Internal Medicine, Division of Gastroenterology , University Hospital Rijeka , Croatia , Rijeka
| | - Davor Stimac
- b Department of Internal Medicine, Division of Gastroenterology , University Hospital Rijeka , Croatia , Rijeka
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36
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Betzel B, Homan J, Aarts EO, Janssen IMC, de Boer H, Wahab PJ, Groenen MJM, Berends FJ. Weight reduction and improvement in diabetes by the duodenal-jejunal bypass liner: a 198 patient cohort study. Surg Endosc 2016; 31:2881-2891. [PMID: 27804045 DOI: 10.1007/s00464-016-5299-6] [Citation(s) in RCA: 24] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/15/2016] [Accepted: 10/14/2016] [Indexed: 02/08/2023]
Abstract
BACKGROUND The duodenal-jejunal bypass liner (DJBL) is an endoscopic treatment for patients with type 2 diabetes mellitus (T2DM) and (morbid) obesity. The aim of the current study was to determine its efficacy and safety profile. METHODS Inclusion criteria for treatment with a DJBL were: age 18-70 years, BMI 28-45 kg/m2, and T2DM with a HbA1c > 48 mmol/mol. Primary outcomes were changes in HbA1c and body weight. Secondary outcomes included changes in blood pressure, lipids, and anti-diabetic medication. Predictive factors for success of treatment with the DJBL were determined. RESULTS Between 2011 and 2014, 185 out of 198 patients successfully underwent a DJBL implantation procedure, with an intended implantation time of 12 months. In these 185 patients, body weight decreased by 12.8 ± 8.0 kg (total body weight loss of 11.9 ± 6.9 %, p < 0.001), HbA1c decreased from 67 to 61 mmol/mol (p < 0.001) despite a reduction in anti-diabetic medication, and blood pressure and serum lipid levels all decreased. In total, 57 (31 %) DJBLs were explanted early after a median duration of 33 weeks. Adverse events occurred in 17 % of patients. C-peptide ≥1.0 nmol/L and body weight ≥107 kg at screening were independent predictive factors for success. CONCLUSIONS Treatment with the DJBL in T2DM patients with (morbid) obesity results in improvement in glucose control, a reduction in anti-diabetic medication, and significant weight loss. The largest changes are observed within the first 3-6 months. Initial C-peptide levels and body weight may help to select patients with the greatest chance of success.
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Affiliation(s)
- Bark Betzel
- Department of Surgery, Rijnstate Hospital, Postal Number 1190, 6800 TA, Arnhem, The Netherlands.
| | - Jens Homan
- Department of Surgery, Rijnstate Hospital, Postal Number 1190, 6800 TA, Arnhem, The Netherlands
| | - Edo O Aarts
- Department of Surgery, Rijnstate Hospital, Postal Number 1190, 6800 TA, Arnhem, The Netherlands
| | - Ignace M C Janssen
- Department of Surgery, Rijnstate Hospital, Postal Number 1190, 6800 TA, Arnhem, The Netherlands
| | - Hans de Boer
- Department of Internal Medicine, Rijnstate Hospital, Arnhem, The Netherlands
| | - Peter J Wahab
- Department of Gastroenterology, Rijnstate Hospital, Arnhem, The Netherlands
| | - Marcel J M Groenen
- Department of Gastroenterology, Rijnstate Hospital, Arnhem, The Netherlands
| | - Frits J Berends
- Department of Surgery, Rijnstate Hospital, Postal Number 1190, 6800 TA, Arnhem, The Netherlands
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Štimac D, Klobučar Majanović S, Ličina M. Recent Trends in Endoscopic Management of Obesity. Surg Innov 2016; 23:525-537. [PMID: 27072642 DOI: 10.1177/1553350616643615] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 08/29/2023]
Abstract
Obesity remains a tremendous public health, clinical, and scientific challenge globally. Conventional approaches in the management of obesity offer limited potential for sustained weight loss. Bariatric surgery, although it represents the most effective weight loss treatment, has its own risks and is associated with substantial costs and limited patient applicability. Endoscopic weight loss procedures are considered as the major breakthrough in the management of obesity. Endoluminal interventions performed entirely through the gastrointestinal tract have evolved as a result of an attempt to replicate some of the anatomical features and the physiological effects of the traditional weight loss surgery while being reversible, less invasive, and more cost-effective. Restrictive procedures act to decrease gastric volume by space-occupying devices and/or by suturing or stapling techniques that alter gastric anatomy, whereas malabsorptive procedures tend to create malabsorption by preventing food contact with the duodenum and proximal jejunum. Other procedures act by influencing gastric function (gastric botulinum injections, gastric pacing, and vagal nerve blocking) or by gastric aspiration. It is important to underline that the majority of endoscopic weight loss procedures are still being evaluated and are not yet available routinely. Even though some of the techniques and devices that have recently emerged have demonstrated promising short-term results, evidence on their safety and long-term efficacy from well-designed and well-conducted research should be given before they can become an inherent part of everyday clinical practice. Given the rapid development of endoscopic weight loss procedures, this review considers the current state and recent trends in endoscopic management of obesity.
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Vilarrasa N, de Gordejuela AGR, Casajoana A, Duran X, Toro S, Espinet E, Galvao M, Vendrell J, López-Urdiales R, Pérez M, Pujol J. Endobarrier® in Grade I Obese Patients with Long-Standing Type 2 Diabetes: Role of Gastrointestinal Hormones in Glucose Metabolism. Obes Surg 2016; 27:569-577. [DOI: 10.1007/s11695-016-2311-0] [Citation(s) in RCA: 33] [Impact Index Per Article: 3.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
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Maggi U, Formiga A, Lauro R. Hepatic abscess as a complication of duodenal-jejunal bypass sleeve system and review of the literature. Surg Obes Relat Dis 2016; 12:e47-e50. [DOI: 10.1016/j.soard.2016.02.018] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/29/2016] [Revised: 02/18/2016] [Accepted: 02/18/2016] [Indexed: 12/17/2022]
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Surgical cure for type 2 diabetes by foregut or hindgut operations: a myth or reality? A systematic review. Surg Endosc 2016; 31:25-37. [PMID: 27194257 DOI: 10.1007/s00464-016-4952-4] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/15/2016] [Accepted: 04/18/2016] [Indexed: 02/06/2023]
Abstract
BACKGROUND Bariatric surgery results in remission of type 2 diabetes mellitus in a significant proportion of patients. Animal research has proposed the foregut and hindgut hypotheses as possible mechanisms of remission of T2DM independent of weight loss. These hypotheses have formed the basis of investigational procedures designed to treat T2DM in non-obese (in addition to obese) patients. The aim of this study was to review the procedures that utilise the foregut and hindgut hypotheses to treat T2DM in humans. METHODS A systematic review was conducted to identify the investigational procedures performed in humans that are based on the foregut and hindgut hypotheses and then to assess their outcomes. RESULTS Twenty-four studies reported novel procedures to treat T2DM in humans; only ten utilised glycated haemoglobin A1c (HbA1c) in their definition of remission. Reported remission rates were 20-40 % for duodenal-jejunal bypass (DJB), 73-93 % for duodenal-jejunal bypass with sleeve gastrectomy (DJB-SG), 62.5-100 % for duodenal-jejunal bypass sleeve (DJBS) and 47-95.7 % for ileal interposition with sleeve gastrectomy (II-SG). When using a predetermined level of HbA1c to define remission, the remission rates were lower (27, 63, 0 and 65 %) for DJB, DJB-SG, DJBS and II-SG. CONCLUSIONS The outcomes of the foregut- and hindgut-based procedures are not better than the outcomes of just one of their components, namely sleeve gastrectomy. The complexity of these procedures in addition to their comparable outcomes to a simpler operation questions their utility.
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Is Endoluminal Bariatric Therapy a New Paradigm of Treatment for Obesity? Clin Gastroenterol Hepatol 2016; 14:507-15. [PMID: 26775714 DOI: 10.1016/j.cgh.2015.12.043] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/24/2015] [Revised: 12/10/2015] [Accepted: 12/21/2015] [Indexed: 02/07/2023]
Abstract
The prevalence of obesity has steadily increased throughout recent decades, and along with it, the costs of caring for the associated comorbid conditions has increased as well. Traditional bariatric surgical procedures generally are safe and effective, but patient acceptance, the risk of minor and sometimes serious complications, costs, and insurance coverage have limited the application of these techniques to the treatment of a minority of patients. Endoluminal techniques represent newer approaches to weight loss that can be used independently or in concert with traditional medical and surgical treatments for obesity, with varying degrees of success. It is anticipated that less invasiveness will increase the appeal across a broader representation of patients, perhaps increasing the number of obese patients who choose an intervention over medical management and possibly resulting in a greater total loss of excess body weight across a population; this may reduce costs involved in treating the complications of weight-related comorbidities. Acceptance of endoluminal bariatric procedures and devices will hinge on proving safety, efficacy, and value.
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Rohde U, Hedbäck N, Gluud LL, Vilsbøll T, Knop FK. Effect of the EndoBarrier Gastrointestinal Liner on obesity and type 2 diabetes: a systematic review and meta-analysis. Diabetes Obes Metab 2016; 18:300-5. [PMID: 26537317 DOI: 10.1111/dom.12603] [Citation(s) in RCA: 92] [Impact Index Per Article: 10.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/07/2015] [Revised: 10/02/2015] [Accepted: 10/31/2015] [Indexed: 12/13/2022]
Abstract
Compared with bariatric surgery, less invasive and reversible techniques to counteract obesity and type 2 diabetes (T2D) have been developed, including the EndoBarrier Gastrointestinal Liner [duodenal-jejunal bypass sleeve (DJBS)]. We conducted a systematic review and meta-analyses of eligible trials to evaluate the efficacy and safety of the DJBS. Five randomized controlled trials (RCTs; 235 subjects) and 10 observational studies (211 subjects) were included. The risk of bias was evaluated as high in all studies. The mean body mass index ranged from 30 to 49.2 kg/m(2) and 10-100% of the subjects had T2D. Meta-analysis showed that the DJBS was associated with significant mean differences in body weight and excess weight loss of -5.1 kg [95% confidence interval (CI) -7.3, -3.0; four trials; n = 151; I(2) = 37%] and 12.6% (95% CI 9.0, 16.2; four trials; n = 166; I(2) = 24%), respectively, compared with diet modification. The mean differences in glycated haemoglobin (-0.9%; 95% CI -1.8, 0.0) and fasting plasma glucose (-3.7 mM; 95% CI -8.2, 0.8) among subjects with T2D did not reach statistical significance. Adverse events consisted mainly of abdominal pain, nausea and vomiting. No deaths occurred. Future high-quality long-term RCTs are needed to further assess efficacy and safety.
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Affiliation(s)
- U Rohde
- Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
| | - N Hedbäck
- Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
| | - L L Gluud
- Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
- GastroUnit, Medical Section, Hvidovre Hospital, University of Copenhagen, Hvidovre, Denmark
| | - T Vilsbøll
- Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
| | - F K Knop
- Center for Diabetes Research, Gentofte Hospital, University of Copenhagen, Hellerup, Denmark
- Department of Biomedical Sciences, NNF Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
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Betzel B, Koehestanie P, Aarts EO, Dogan K, Homan J, Janssen IMC, Wahab PJ, Groenen MJM, Berends FJ. Safety experience with the duodenal-jejunal bypass liner: an endoscopic treatment for diabetes and obesity. Gastrointest Endosc 2015; 82:845-52. [PMID: 25952090 DOI: 10.1016/j.gie.2015.03.1911] [Citation(s) in RCA: 26] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/10/2014] [Accepted: 03/03/2015] [Indexed: 02/08/2023]
Abstract
BACKGROUND The duodenal-jejunal bypass liner (DJBL) is a new, device-based endoscopic treatment for type 2 diabetes mellitus (T2DM) and obesity. OBJECTIVE To report serious safety events of subjects treated with the DJBL while offering a simple guideline to mitigate risk. DESIGN Single-center observational study. SETTING Tertiary referral center. PATIENTS For commercial use, patients were eligible for implantation of the DJBL when they met the following criteria: age 18 to 65 years, body mass index 28 to 45 kg/m(2), T2DM, and negative serum Helicobacter pylori test. INTERVENTIONS Endoscopic implantation of the DJBL. MAIN OUTCOME MEASUREMENTS Adverse events, serious adverse events, early explantation. RESULTS Between October 2007 and January 2014, 152 of 165 planned implantations (92%) and 94 explantations were performed in our center. Significant weight loss and improvement in T2DM and other cardiovascular parameters were achieved. Early removal of the device occurred because of persistent GI symptoms in 16 patients (11%). Serious adverse events were observed in a subset of patients: 7 GI bleeds, 5 of which required early removal; 2 cases of pancreatitis; 1 case of hepatic abscess; and 1 obstruction of the sleeve. Explantation resulted in an esophageal tear in 2 cases. LIMITATIONS Single-center study. CONCLUSION The DJBL improves glycemic control while causing weight loss. The safety profile of the DJBL demonstrates a reasonable tolerability profile. However, serious safety adverse events can occur. Patient selection, expert use of the device at placement and removal, and the supportive care of an experienced multidisciplinary team are key for safe and effective use of the DJBL.
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Affiliation(s)
- Bark Betzel
- Department of General Surgery, Rijnstate Hospital, Arnhem, the Netherlands
| | | | - Edo O Aarts
- Department of General Surgery, Rijnstate Hospital, Arnhem, the Netherlands
| | - Kemal Dogan
- Department of General Surgery, Rijnstate Hospital, Arnhem, the Netherlands
| | - Jens Homan
- Department of General Surgery, Rijnstate Hospital, Arnhem, the Netherlands
| | - Ignace M C Janssen
- Department of General Surgery, Rijnstate Hospital, Arnhem, the Netherlands
| | - Peter J Wahab
- Department of Gastroenterology, Rijnstate Hospital, Arnhem, the Netherlands
| | - Marcel J M Groenen
- Department of Gastroenterology, Rijnstate Hospital, Arnhem, the Netherlands
| | - Frits J Berends
- Department of General Surgery, Rijnstate Hospital, Arnhem, the Netherlands
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Endoscopic Bypass Using Endobarrier Devices: Efficacy in Treating Obesity and Metabolic Syndrome. J Clin Gastroenterol 2015; 49:799-803. [PMID: 26302497 DOI: 10.1097/mcg.0000000000000396] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/19/2023]
Abstract
Obesity is a rapidly growing pandemic. Scope of pharmacotherapy and bariatric surgery in managing obesity is ever rising. The role of minimally invasive techniques to achieve preoperative weight loss and improve postbariatric surgery outcomes is an area of new interest. The initial experience with endobarrier devices in achieving weight loss among obese subjects has shown promising results. In addition, the impact of these interventions on comorbidities commonly associated with obesity like diabetes mellitus type 2 and hyperlipidemia has further expanded their potential for use in future. In this review article, we have summarized case report, prospective single and multicenter studies, and randomized-controlled trials describing the use of endobarrier devices. Indications, techniques, outcomes, limitations, and complications reported are discussed.
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Cohen R, Galvão Neto MP, Roux CL. Another look at the (endoscopic duodenal liner) ENDO trial, or how to avoid the burial of a valuable antidiabetic tool. Surg Obes Relat Dis 2015; 12:702-704. [PMID: 26775047 DOI: 10.1016/j.soard.2015.08.503] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/05/2015] [Revised: 08/07/2015] [Accepted: 08/10/2015] [Indexed: 12/12/2022]
Affiliation(s)
- Ricardo Cohen
- The Center for Obesity and Diabetes, Oswaldo Cruz German Hospital, Sao Paulo, Brazil
| | | | - Carel Le Roux
- Diabetes Complication Research Centre, UCD Conway Institute, School of Medicine and Medical Science, University College Dublin, Dublin, Ireland
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Advances in the Endoscopic Management of Obesity. Gastroenterol Res Pract 2015; 2015:757821. [PMID: 26106413 PMCID: PMC4461770 DOI: 10.1155/2015/757821] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/03/2014] [Accepted: 04/25/2015] [Indexed: 12/13/2022] Open
Abstract
Obesity has become a worldwide epidemic with significant impact on quality of life, morbidity, and mortality rates. Over the past two decades, bariatric surgery has established itself as the most effective and durable treatment for patients with obesity and its associated comorbidities. However, despite the use of minimally invasive techniques, bariatric surgery is associated with complications in approximately 15% of patients, has a substantial cost, and is used by only 1% of patients who are eligible. Therefore, there is a need for effective minimally invasive therapies, which will be utilized by the large proportion of obese patients who are in desperate need of treatment but are not receiving any. Endoscopic approaches to the management of obesity have been developed, with the aim of delivering more effective, durable, and safer methods of weight reduction. In this paper, we review currently available and future endoscopic therapies that will likely join the armamentarium used in the management of obesity.
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Derosa G, Maffioli P. Possible therapies for obesity: focus on the available options for its treatment. Nutrition 2015; 31:542-3. [PMID: 25701348 DOI: 10.1016/j.nut.2014.09.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/26/2014] [Revised: 09/14/2014] [Accepted: 09/15/2014] [Indexed: 11/25/2022]
Affiliation(s)
- Giuseppe Derosa
- Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy; Center for the Study of Endocrine-Metabolic Pathophysiology and Clinical Research, University of Pavia, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy
| | - Pamela Maffioli
- Department of Internal Medicine and Therapeutics, University of Pavia, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy; PhD School in Experimental Medicine, University of Pavia, Pavia, Italy
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Koehestanie P, Betzel B, Aarts EO, Janssen IMC, Wahab P, Berends FJ. Is reimplantation of the duodenal-jejunal bypass liner feasible? Surg Obes Relat Dis 2015; 11:1099-104. [PMID: 25979208 DOI: 10.1016/j.soard.2015.01.016] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/13/2014] [Revised: 01/18/2015] [Accepted: 01/20/2015] [Indexed: 10/24/2022]
Abstract
BACKGROUND The endoscopic ally implanted DJBL is a 60-cm impermeable fluoropolymer device, which prevents food from making contact with the proximal intestine. It was designed to induce weight loss and treat type 2 diabetes mellitus (T2DM). OBJECTIVES To evaluate the feasibility, safety, and effectiveness of duodenal-jejunal bypass liner (DJBL) reimplantation. SETTING Prospective, observational study was conducted at the department of surgery and gastroenterology of the Rijnstate hospital, Arnhem, the Netherlands, between 2009 and 2011. METHODS Five obese patients with T2DM with body mass index (BMI) = Mass (kg) / height (m(2)), ranging from 30-35 kg/m(2) who completed the follow-up after their first implant and underwent removal of the DJBL after 6 months, were selected for reimplantation after an additional 18 months of follow-up. Weight loss, BMI, and HbA1 c were analyzed before and twelve months after reimplantation. RESULTS In all 5 patients, the DJBL was implanted and explanted without any complications. Also the reimplantation and reexplantation occurred without any complications. Median weight decreased significantly from 105 kg to 95 kg, and BMI decreased from 33 to 29. The glycated hemoglobin (HbA1 c) level decreased from 8.4% to 7.3% by the first implantation but it wasn't significant. CONCLUSIONS Reimplantation of DJBL is feasible, deemed safe, and showed additional weight loss.
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Affiliation(s)
- P Koehestanie
- Department of Surgery, Rijnstate Hospital, the Netherlands.
| | - B Betzel
- Department of Surgery, Rijnstate Hospital, the Netherlands
| | - E O Aarts
- Department of Surgery, Rijnstate Hospital, the Netherlands
| | - I M C Janssen
- Department of Surgery, Rijnstate Hospital, the Netherlands
| | - P Wahab
- Department of Gastroenterology, Rijnstate Hospital, the Netherlands
| | - F J Berends
- Department of Surgery, Rijnstate Hospital, the Netherlands
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50
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The effect of the endoscopic duodenal-jejunal bypass liner on obesity and type 2 diabetes mellitus, a multicenter randomized controlled trial. Ann Surg 2015; 260:984-92. [PMID: 25072436 DOI: 10.1097/sla.0000000000000794] [Citation(s) in RCA: 103] [Impact Index Per Article: 10.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/06/2023]
Abstract
OBJECTIVE Investigate the safety and efficacy of 6 months' duodenal-jejunal bypass liner (DJBL) treatment in comparison with dietary intervention for obesity and type 2 diabetes mellitus (T2DM). BACKGROUND The DJBL is a bariatric procedure involving an impermeable sleeve that is delivered endoscopically in the proximal intestine. This procedure not only is less invasive than conventional surgical techniques but also has beneficial effects on obesity and T2DM. METHODS A multicenter randomized controlled trial was conducted. Seventy-seven patients with obesity and T2DM were included. Thirty-eight patients were randomized to 6 months' DJBL treatment in combination with dietary intervention (34 successfully implanted, 31 completed the study), 39 patients received only dietary intervention (controls, 35 completed the study). Total study duration for both groups was 12 months, including 6 months of post-DJBL removal follow-up. RESULTS After 6 months, just before DJBL removal, the DJBL group had lost 32.0% [22.0%-46.7%] of their excess weight versus 16.4% [4.1%-34.6%] in the control group (P < 0.05). Glycated hemoglobin A1c levels improved to 7.0% [6.4%-7.5%] in the DJBL group and to 7.9% [6.6%-8.3%] in the control group (P < 0.05). In addition, 85.3% of DJBL patients showed decreased postprandial glucose excursions versus 48.7% of control patients (P < 0.05). At 12 months, excess weight loss of the DJBL group was 19.8% [10.6%-45.0%] versus 11.7% [1.4%-25.4%] in the control group (P < 0.05). HbA1c was 7.3% [6.6%-8.0%] versus 8.0% [6.8%-8.8%], DJBL versus control respectively (P = ns). CONCLUSIONS The DJBL is a safe and effective alternative to invasive bariatric procedures. Six months of DJBL treatment combined with diet leads to superior weight loss and improvement of T2DM when compared with diet alone.
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