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Angeramo CA, Lendoire M, Herbella FAM, Schlottmann F. Efficacy and safety of antireflux mucosectomy versus radiofrequency ablation of the lower esophageal sphincter for the treatment of GERD: a systematic review and meta-analysis. Gastrointest Endosc 2024:S0016-5107(24)03830-6. [PMID: 39716536 DOI: 10.1016/j.gie.2024.12.026] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/27/2024] [Revised: 11/19/2024] [Accepted: 12/11/2024] [Indexed: 12/25/2024]
Abstract
BACKGROUND AND AIMS GERD affects 10% to 30% of the population. Endoscopic antireflux therapies have been proposed for carefully selected patients. In this study, we compared outcomes between endoscopic antireflux mucosectomy (ARMS) and endoscopic radiofrequency ablation of the lower esophageal sphincter (Stretta procedure) for the treatment of GERD. METHODS A systematic review using the MEDLINE database was performed to identify original articles analyzing outcomes after ARMS and Stretta procedures. The main outcomes were patient satisfaction, GERD Health-Related Quality of Life (GERD-HRQL) scores, proton pump inhibitor (PPI) use, and DeMeester scores. Secondary outcomes were postprocedural adverse events. A meta-analysis of proportions and linear regression models was used to assess the effect of each endoscopic procedure on the different outcomes. RESULTS Sixty-six studies comprising 3767 patients were included, with 3074 patients (81.60%) undergoing Stretta and 693 (18.40%) ARMS. The weighted pooled patient satisfaction rates were 65% (95% confidence interval [CI], 52-76) for ARMS and 77% (95% CI, 64-87) for Stretta. Both treatments significantly reduced PPI use (from 100% to 40.18% for ARMS vs from 99.42% to 48.51% for Stretta, P = .20) and improved GERD-HRQL scores (pre 19.75 to post 8.24 for ARMS vs pre 21.02 to post 10.45 for Stretta, P = .70). DeMeester scores improved similarly after both procedures (pre 44.99 to post 15.02 for ARMS vs pre 52.29 to post 28.99 for Stretta, P = .48). ARMS was associated with higher overall morbidity (25% vs 17%, P = .001) and greater risks of stricture (odds ratio [OR], 13.03; 95% CI, 7.83-21.71), bleeding (OR, 13.16; 95% CI, 8.60-20.15), and perforation (OR, 13.03; 95% CI, 7.82-21.71) compared with Stretta. CONCLUSIONS Both Stretta and ARMS are effective endoscopic treatment modalities for GERD. Although their clinical efficacy appears to be similar, the increased risk of dysphagia, bleeding, and perforation after ARMS should not be underestimated.
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Affiliation(s)
- Cristian A Angeramo
- Department of Surgery, Hospital Alemán of Buenos Aires, Buenos Aires, Argentina
| | - Mateo Lendoire
- Department of Surgery, Hospital Alemán of Buenos Aires, Buenos Aires, Argentina
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Lee AY, Kim SH, Cho JY. Comparative evaluation of endoscopic anti-reflux mucosectomy and stretta radiofrequency ablation in the management of gastroesophageal reflux disease: insights from a retrospective multicenter cohort study. Surg Endosc 2024; 38:4278-4286. [PMID: 38866947 DOI: 10.1007/s00464-024-10947-z] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/04/2024] [Accepted: 05/19/2024] [Indexed: 06/14/2024]
Abstract
BACKGROUND Treatment options for gastroesophageal reflux disease (GERD) that is unresponsive to proton pump inhibitors (PPIs) remain limited. Therefore, we compared the therapeutic effects of anti-reflux mucosectomy (ARMS) and Stretta radiofrequency (SRF) for intractable GERD in over 400 individuals who underwent either procedure. METHODS We conducted a retrospective study between 2016 and 2023 to evaluate the effectiveness of SRF and ARMS treatments for refractory GERD. The primary measure of success was the change in the GERD questionnaire (GERDQ) score. The secondary outcomes were various GERD-related indicators, including endoscopic Los Angeles (LA) classification, Hill's type-based flap valve grade (FVG), EndoFLIP™ distensibility index (DI), rate of PPI discontinuation, resolution rate of Barrett's esophagus, and incidence of adverse events. RESULTS The ARMS group included patients with high GERDQ scores, FVG, LA grade, and Barrett's esophagus. Both groups had similar rates of improvements in GERDQ score (P = 0.884) and PPI withdrawal (P = 0.866); however, the ARMS group had significantly more side effects and improvements in the median change in GERDQ score (P = 0.011), FVG (P < 0.001), LA grade (P < 0.001), EndoFLIP™ DI (P < 0.001), and resolution of Barrett's esophagus (P < 0.001). CONCLUSIONS The ARMS group had a greater GERDQ score improvement than the SRF group but had symptom relief and PPI discontinuation rates similar to those of the SRF group. However, objective measures, including EndoFLIP™ DI and endoscopic evaluations, were better in the ARMS group than in the SRF group.
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Affiliation(s)
- Ah Young Lee
- Division of Gastroenterology, Department of Internal Medicine, Cha Gangnam Medical Center, College of Medicine, Cha University, 566, Nonhyeon-Ro, Gangnam-Gu, Seoul, Republic of Korea
- Department of Internal Medicine, Korea University College of Medicine, Seoul, Korea
| | - Seong Hwan Kim
- Division of Gastroenterology, Department of Internal Medicine, Cha Gangnam Medical Center, College of Medicine, Cha University, 566, Nonhyeon-Ro, Gangnam-Gu, Seoul, Republic of Korea
| | - Joo Young Cho
- Division of Gastroenterology, Department of Internal Medicine, Cha Gangnam Medical Center, College of Medicine, Cha University, 566, Nonhyeon-Ro, Gangnam-Gu, Seoul, Republic of Korea.
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Slater BJ, Collings A, Dirks R, Gould JC, Qureshi AP, Juza R, Rodríguez-Luna MR, Wunker C, Kohn GP, Kothari S, Carslon E, Worrell S, Abou-Setta AM, Ansari MT, Athanasiadis DI, Daly S, Dimou F, Haskins IN, Hong J, Krishnan K, Lidor A, Litle V, Low D, Petrick A, Soriano IS, Thosani N, Tyberg A, Velanovich V, Vilallonga R, Marks JM. Multi-society consensus conference and guideline on the treatment of gastroesophageal reflux disease (GERD). Surg Endosc 2023; 37:781-806. [PMID: 36529851 DOI: 10.1007/s00464-022-09817-3] [Citation(s) in RCA: 45] [Impact Index Per Article: 22.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/29/2022] [Accepted: 12/02/2022] [Indexed: 12/23/2022]
Abstract
BACKGROUND Gastroesophageal reflux disease (GERD) is one of the most common diseases in North America and globally. The aim of this guideline is to provide evidence-based recommendations regarding the most utilized and available endoscopic and surgical treatments for GERD. METHODS Systematic literature reviews were conducted for 4 key questions regarding the surgical and endoscopic treatments for GERD in adults: preoperative evaluation, endoscopic vs surgical or medical treatment, complete vs partial fundoplication, and treatment for obesity (body mass index [BMI] ≥ 35 kg/m2) and concomitant GERD. Evidence-based recommendations were formulated using the GRADE methodology by subject experts. Recommendations for future research were also proposed. RESULTS The consensus provided 13 recommendations. Through the development of these evidence-based recommendations, an algorithm was proposed for aid in the treatment of GERD. Patients with typical symptoms should undergo upper endoscopy, manometry, and pH-testing; additional testing may be required for patients with atypical or extra-esophageal symptoms. Patients with normal or abnormal findings on manometry should consider undergoing partial fundoplication. Magnetic sphincter augmentation or fundoplication are appropriate surgical procedures for adults with GERD. For patients who wish to avoid surgery, the Stretta procedure and transoral incisionless fundoplication (TIF 2.0) were found to have better outcomes than proton pump inhibitors alone. Patients with concomitant obesity were recommended to undergo either gastric bypass or fundoplication, although patients with severe comorbid disease or BMI > 50 should undergo Roux-en-Y gastric bypass for the additional benefits that follow weight loss. CONCLUSION Using the recommendations an algorithm was developed by this panel, so that physicians may better counsel their patients with GERD. There are certain patient factors that have been excluded from included studies/trials, and so these recommendations should not replace surgeon-patient decision making. Engaging in the identified research areas may improve future care for GERD patients.
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Affiliation(s)
- Bethany J Slater
- University of Chicago Medicine, 5841 S. Maryland Avenue, MC 4062, Chicago, IL, USA.
| | - Amelia Collings
- Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA
| | - Rebecca Dirks
- Department of Surgery, Indiana University School of Medicine, Indianapolis, IN, USA
| | - Jon C Gould
- Division of Minimally Invasive and Gastrointestinal Surgery, Department of Surgery, Medical College of Wisconsin, Milwaukee, WI, USA
| | - Alia P Qureshi
- Division of General & GI Surgery, Foregut Surgery, Oregon Health & Science University, Portland, OR, USA
| | - Ryan Juza
- Department of Surgery, University of Wisconsin, Madison, WI, USA
| | - María Rita Rodríguez-Luna
- Research Institute Against Digestive Cancer (IRCAD) and ICube Laboratory, Photonics Instrumentation for Health, Strasbourg, France
| | | | - Geoffrey P Kohn
- Department of Surgery, Monash University, Melbourne, VIC, Australia
| | - Shanu Kothari
- Department of Surgery, Prisma Health, Greenville, SC, USA
| | | | | | - Ahmed M Abou-Setta
- Department of Community Health Sciences, University of Manitoba, Winnipeg, Canada
| | - Mohammed T Ansari
- School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada
| | | | - Shaun Daly
- Department of Surgery, University of California, Irvine, Orange, CA, USA
| | | | - Ivy N Haskins
- Department of Surgery, University of Nebraska Medical Center, Omaha, USA
| | - Julie Hong
- Department of Surgery, New York Presbyterian/Queens, Queens, USA
| | | | - Anne Lidor
- Department of Surgery, University of Wisconsin, Madison, WI, USA
| | - Virginia Litle
- Section of Thoracic Surgery, Department of Cardiovascular Surgery, Intermountain Healthcare, Salt Lake City, UT, USA
| | - Donald Low
- Virginia Mason Medical Center, Seattle, WA, USA
| | - Anthony Petrick
- Department of General Surgery, Geisinger School of Medicine, Geisinger Medical Center, Danville, PA, USA
| | - Ian S Soriano
- Department of Surgery, University of California San Francisco School of Medicine, San Francisco, CA, USA
| | - Nirav Thosani
- McGovern Medical School, Center for Interventional Gastroenterology at UTHealth, Houston, TX, USA
| | - Amy Tyberg
- Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA
| | - Vic Velanovich
- Division of Gastrointestinal Surgery, Tampa General, Tampa, FL, USA
| | - Ramon Vilallonga
- Endocrine, Metabolic and Bariatric Unit, General Surgery Department, Vall d'Hebron University Hospital, Center of Excellence for the EAC-BC, Universitat Autònoma de Barcelona, Barcelona, Spain
| | - Jeffrey M Marks
- Case Western Reserve University School of Medicine, University Hospitals Cleveland Medical Center, Cleveland, OH, USA
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Shibli F, Sandhu DS, Fass R. The Discrepancy Between Subjective and Objective Clinical Endpoints in Gastroesophageal Reflux Disease. J Clin Gastroenterol 2022; 56:375-383. [PMID: 35324484 DOI: 10.1097/mcg.0000000000001687] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/10/2022]
Abstract
Therapeutic outcome in gastroesophageal reflux disease (GERD) is commonly determined by both subjective and objective clinical endpoints. Clinicians frequently use symptom improvement as a key benchmark of clinical success, in conjunction with normalization of objective parameters such as esophageal acid exposure and inflammation. However, GERD therapeutic trials have demonstrated that a substantial number of patients rendered asymptomatic, whether through medical, surgical, or endoscopic intervention, continue to have persistent abnormal esophageal acid exposure and erosive esophagitis. The opposite has also been demonstrated in therapeutic trials, where patients remained symptomatic despite normalization of esophageal acid exposure and complete resolution of esophageal inflammation. Moreover, there is no substantive evidence that symptomatic response to antireflux treatment requires complete esophageal mucosal healing or normalization of esophageal acid exposure. Thus, it appears that a certain level of improvement in objective parameters is needed to translate into meaningful changes in symptoms and health-related quality of life of GERD patients. This supports the need to reconsider the commonly used "hard" clinical endpoints to evaluate therapeutic trials in GERD.
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Affiliation(s)
- Fahmi Shibli
- Division of Gastroenterology and Hepatology, The Esophageal and Swallowing Center, MetroHealth Medical Center and Case Western Reserve University, Cleveland, OH
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Huynh P, Konda V, Sanguansataya S, Ward MA, Leeds SG. Mind the Gap: Current Treatment Alternatives for GERD Patients Failing Medical Treatment and Not Ready for a Fundoplication. Surg Laparosc Endosc Percutan Tech 2020; 31:264-276. [PMID: 33347088 PMCID: PMC8154178 DOI: 10.1097/sle.0000000000000888] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/13/2020] [Accepted: 10/05/2020] [Indexed: 01/08/2023]
Abstract
BACKGROUND Gastroesophageal reflux disease is associated with Barrett esophagus, esophageal adenocarcinoma, and significantly impacts quality of life. Medical management is the first line therapy with surgical fundoplication as an alternative therapy. However, a small portion of patients who fail medical therapy are referred for surgical consultation. This creates a "gap" in therapy for those patients dissatisfied with medical therapy but are not getting referred for surgical consultation. Three procedures have been designed to address these patients. These include radiofrequency ablation (RFA) of the lower esophageal sphincter, transoral incisionless fundoplication (TIF), and magnetic sphincter augmentation. MATERIALS AND METHODS A Pubmed literature review was conducted of all publications for RFA, TIF, and MSA. Four most common endpoints for the 3 procedures were compared at different intervals of follow-up. These include percent of patients off proton pump inhibitors (PPIs), GERD-HRQL score, DeMeester score, and percent of time with pH <4. A second query was performed for patients treated with PPI and fundoplications to match the same 4 endpoints as a control. RESULTS Variable freedom from PPI was reported at 1 year for RFA with a weighted mean of 62%, TIF with a weighted mean of 61%, MSA with a weighted mean of 85%, and fundoplications with a weighted mean of 84%. All procedures including PPIs improved quality-of-life scores but were not equal. Fundoplication had the best improvement followed by MSA, TIF, RFA, and PPI, respectively. DeMeester scores are variable after all procedures and PPIs. All MSA studies showed normalization of pH, whereas only 4 of 17 RFA studies and 3 of 11 TIF studies reported normalization of pH. CONCLUSIONS Our literature review compares 3 rival procedures to treat "gap" patients for gastroesophageal reflux disease with 4 common endpoints. Magnetic sphincter augmentation appears to have the most reproducible and linear outcomes but is the most invasive of the 3 procedures. MSA outcomes most closely mirrors that of fundoplication.
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Affiliation(s)
- Phuong Huynh
- Division of Minimally Invasive Surgery, Baylor University Medical Center
- Center for Advanced Surgery, Baylor Scott & White Health
| | - Vani Konda
- Center for Esophageal Diseases, Baylor University Medical Center, Dallas
| | | | - Marc A. Ward
- Division of Minimally Invasive Surgery, Baylor University Medical Center
- Center for Advanced Surgery, Baylor Scott & White Health
- Texas A&M College of Medicine, Bryan, TX
| | - Steven G. Leeds
- Division of Minimally Invasive Surgery, Baylor University Medical Center
- Center for Advanced Surgery, Baylor Scott & White Health
- Texas A&M College of Medicine, Bryan, TX
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Ahmed M, Lau A, Hirpara DH, Kidane B. Choosing the right survey-patient reported outcomes in esophageal surgery. J Thorac Dis 2020; 12:6902-6912. [PMID: 33282393 PMCID: PMC7711431 DOI: 10.21037/jtd.2020.03.58] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/26/2022]
Abstract
Patient reported outcomes (PROs) fulfill a crucial and unique niche in patient management, providing health-care providers a glimpse into their patients’ health experience. This is of utmost importance in patients with benign and malignant disorders of esophagus requiring surgery, which carries significant morbidity, in part due to a high burden of symptoms affecting health-related quality of life (HRQOL). There are a variety of generic and disease-specific patient reported outcome measures (PROMs) available for use in esophageal surgery. This article provides a broad overview of commonly used HRQOL instruments in esophageal surgery, including their utility in comparative effectiveness research, prognostication and shared decision-making for patients undergoing surgery for benign and malignant disorders of the esophagus.
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Affiliation(s)
- Maira Ahmed
- College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
| | - Angus Lau
- College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
| | - Dhruvin H Hirpara
- Department of Surgery, University of Toronto, Toronto, Ontario, Canada
| | - Biniam Kidane
- College of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada.,Section of Thoracic Surgery, Health Sciences Centre, Winnipeg, Manitoba, Canada.,Research Institute in Oncology and Hematology, Cancer Care Manitoba, Manitoba, Canada
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Dobashi A, Wu SW, Deters JL, Miller CA, Knipschield MA, Cameron GP, Lu L, Rajan E, Gostout CJ. Endoscopic magnet placement into subadventitial tunnels for augmenting the lower esophageal sphincter using submucosal endoscopy: ex vivo and in vivo study in a porcine model (with video). Gastrointest Endosc 2019; 89:422-428. [PMID: 30261170 DOI: 10.1016/j.gie.2018.09.015] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/10/2018] [Accepted: 09/17/2018] [Indexed: 02/08/2023]
Abstract
BACKGROUND AND AIMS Endolumenal therapies serve as a treatment option for GERD. This study aimed to determine if magnets could be placed endoscopically using the adventitial layer to create a subadventitial space near the esophagogastric junction to augment the lower esophageal sphincter using submucosal endoscopy. METHODS This study consisted of 2 phases, ex vivo and in vivo, with domestic pig esophagus. A long submucosal tunnel was made at the mid to lower esophagus. The muscularis propria was incised by a needle-knife within the submucosal tunnel. A subadventitial tunnel was made by biliary balloon catheter blunt dissection, and a magnet was deployed in the subadventitial space. The same maneuver was done within the opposing esophageal wall, with magnet placement in the opposing subadventitial space. RESULTS Submucosal tunnels and subadventitial tunnels were successful without perforation ex vivo in all attempts and in 9 of 10 cases, respectively. Magnets were deployed in the subadventitial space in 7 cases. Magnets connected and separated with atraumatic endoscope passage into the stomach and reconnected when the endoscope was withdrawn under fluoroscopy in 5 of 7 cases (71.4%). In vivo submucosal tunnels and subadventitial tunnels were successful in all 5 cases, and magnet augmentation was functionally active in 4 cases (80%). CONCLUSION Subadventitial tunnels were feasible and could represent a new working space for endoscopic treatment. Endoscopic placement of magnets within the subadventitial space may be an attractive alternative endolumenal therapy for GERD.
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Affiliation(s)
- Akira Dobashi
- Developmental Endoscopy Unit, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Shu-Wei Wu
- Department of Physiology and Biomedical Engineering and Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota, USA
| | - Jodie L Deters
- Developmental Endoscopy Unit, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Charles A Miller
- Developmental Endoscopy Unit, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Mary A Knipschield
- Developmental Endoscopy Unit, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Graham P Cameron
- Electronics Development Unit, Division of Engineering and Technology Services, Mayo Clinic, Rochester, Minnesota, USA
| | - Lichun Lu
- Department of Physiology and Biomedical Engineering and Department of Orthopedic Surgery, Mayo Clinic, Rochester, Minnesota, USA
| | - Elizabeth Rajan
- Developmental Endoscopy Unit, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
| | - Christopher J Gostout
- Developmental Endoscopy Unit, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA
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Systematic review and meta-analysis of controlled and prospective cohort efficacy studies of endoscopic radiofrequency for treatment of gastroesophageal reflux disease. Surg Endosc 2017; 31:4865-4882. [PMID: 28233093 DOI: 10.1007/s00464-017-5431-2] [Citation(s) in RCA: 103] [Impact Index Per Article: 12.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/09/2016] [Accepted: 01/20/2017] [Indexed: 01/08/2023]
Abstract
BACKGROUND The endoscopic radiofrequency procedure (Stretta) has been used for more than a decade to treat patients with gastroesophageal reflux disease (GERD). However, the efficacy of the procedure in improving objective and subjective clinical endpoints needs to be further established. AIM To determine the efficacy of the Stretta procedure in treating patients with GERD, using a systematic review and meta-analysis of controlled and cohort studies. METHODS We conducted a systematic search of the PubMed and Cochrane databases for English language clinical studies of the Stretta procedure, published from inception until May 2016. Randomized controlled trials (RCTs) and cohort studies that included the use of the Stretta procedure in GERD patients were included. A generalized inverse weighting was used for all outcomes. Results were calculated by both fixed effects and random effects model. RESULTS Twenty-eight studies (4 RCTs, 23 cohort studies, and 1 registry) representing 2468 unique Stretta patients were included in the meta-analysis. The (unweighted) mean follow-up time for the 28 studies was 25.4 [14.0, 36.7] months. The pooled results showed that the Stretta reduced (improved) the health-related quality of life score by -14.6 [-16.48, -12.73] (P < 0.001). Stretta also reduced (improved) the pooled heartburn standardized score by -1.53 [-1.97, -1.09] (P < 0.001). After Stretta treatment, only 49% of the patients using proton pump inhibitors (PPIs) at baseline required PPIs at follow-up (P < 0.001). The Stretta treatment reduced the incidence of erosive esophagitis by 24% (P < 0.001) and reduced esophageal acid exposure by a mean of -3.01 [-3.72, -2.30] (P < 0.001). Lower esophageal sphincter (LES) basal pressure was increased post Stretta therapy by a mean of 1.73 [-0.29, 3.74] mmHg (P = NS). CONCLUSIONS The Stretta procedure significantly improves subjective and objective clinical endpoints, except LES basal pressure, and therefore should be considered as a viable alternative in managing GERD.
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Is the Stretta procedure as effective as the best medical and surgical treatments for gastro-oesophageal reflux disease? A best evidence topic. Int J Surg 2016; 30:19-24. [DOI: 10.1016/j.ijsu.2016.03.062] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/08/2015] [Revised: 03/18/2016] [Accepted: 03/23/2016] [Indexed: 12/12/2022]
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Abstract
Multiple new endoluminal devices and therapies have been devised to create a more effective antireflux barrier in patients with gastroesophageal reflux disease (GERD). Most of these therapies have been abandoned, because they were ineffective and/or had significant adverse effects. However, there are currently two therapies (Stretta, EsophyX) that have US Food and Drug Administration approval and continue to be used in select patients with GERD. The clinical management of GERD, disease complications, endoluminal techniques, evidence for efficacy, and controversies concerning endoluminal therapy for GERD are reviewed and discussed.
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Affiliation(s)
- Kristin Hummel
- Department of Surgery, University of South Alabama College of Medicine, Mastin Building, 2451 Fillingim Street, Mobile, AL 36617, USA
| | - William Richards
- Department of Surgery, University of South Alabama College of Medicine, Mastin Building, 2451 Fillingim Street, Mobile, AL 36617, USA.
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How Do You Treat Gastroesophageal Reflux Disease in Your Practice? Med Acupunct 2015. [DOI: 10.1089/acu.2015.29004.cpl] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/12/2022] Open
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Long-term cost-effectiveness of medical, endoscopic and surgical management of gastroesophageal reflux disease. Surgery 2014; 157:126-36. [PMID: 25262216 DOI: 10.1016/j.surg.2014.05.027] [Citation(s) in RCA: 29] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/10/2014] [Accepted: 05/30/2014] [Indexed: 12/12/2022]
Abstract
BACKGROUND The long-term cost effectiveness of medical, endoscopic, and operative treatments for adults with gastroesophageal reflux disease (GERD) remains unclear. We sought to estimate the cost effectiveness of medical, endoscopic, and operative treatments for adults with GERD who require daily proton pump inhibitor (PPI) therapy. METHODS A Markov model was generated from the payer's perspective using a 6-month cycle and 30-year time horizon. The base-case patient was a 45-year-old man with symptomatic GERD taking 20 mg of omeprazole twice daily. Four treatment strategies were analyzed: PPI therapy, transoral incisionless fundoplication (EsophyX), radiofrequency energy application to the lower esophageal sphincter (Stretta) and laparoscopic Nissen fundoplication. The model parameters were selected using the published literature and institutional billing data. The main outcome measure was the incremental cost-effectiveness ratio (cost per quality-adjusted life-year gained) for each therapy. RESULTS In the base case analysis, which assumed a PPI cost of $234 over 6 months ($39 per month), Stretta and laparoscopic Nissen fundoplication were the most cost-effective options over a 30-year time period ($2,470.66 and $5,579.28 per QALY gained, respectively). If the cost of PPI therapy exceeded $90.63 per month over 30 years, laparoscopic Nissen fundoplication became the dominant treatment option. EsophyX was dominated by laparoscopic Nissen fundoplication at all points in time. CONCLUSION Low-cost PPIs, Stretta, and laparoscopic Nissen fundoplication all represent cost-effective treatment strategies. In this model, when PPIs exceed $90 per month, medical therapy is no longer cost effective. Procedural GERD therapy should be considered for patients who require high-dose or expensive PPIs.
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Noar M, Squires P, Noar E, Lee M. Long-term maintenance effect of radiofrequency energy delivery for refractory GERD: a decade later. Surg Endosc 2014; 28:2323-33. [PMID: 24562599 DOI: 10.1007/s00464-014-3461-6] [Citation(s) in RCA: 70] [Impact Index Per Article: 6.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/29/2013] [Accepted: 01/21/2014] [Indexed: 12/16/2022]
Abstract
BACKGROUND Patients with gastroesophageal reflux disease (GERD) often seek alternative therapy for inadequate symptom control, with over 40% not responding to medical treatment. We evaluated the long-term safety, efficacy, and durability of response to radiofrequency treatment of the lower esophageal sphincter (Stretta). METHODS Using an intent-to-treat analysis, we prospectively assessed 217 patients with medically refractory GERD before and after Stretta. There was no concurrent control group in the study. Primary outcome measure was normalization of GERD-health-related quality of life (GERD-HRQL) in 70% or greater of patients at 10 years. Secondary outcomes were 50% reduction or elimination of proton pump inhibitors (PPIs) and 60% or greater improvement in satisfaction at 10 years. Successful treatment was defined as achievement of secondary outcomes in a minimum of 50% of patients. Complications and effect on existing comorbidities were evaluated. The results of a 10-year study are reported. RESULTS The primary outcome was achieved in 72% of patients (95% confidence interval 65-79). For secondary outcomes, a 50% or greater reduction in PPI use occurred in 64% of patients, (41% eliminating PPIs entirely), and a 60% or greater increase in satisfaction occurred in 54% of patients. Both secondary endpoints were achieved. The most common side effect was short-term chest pain (50%). Pre-existing Barrett's metaplasia regressed in 85% of biopsied patients. No cases of esophageal cancer occurred. CONCLUSIONS In this single-group evaluation of 217 patients before and after Stretta, GERD-HRQL scores, satisfaction, and PPI use significantly improved and results were immediate and durable at 10 years.
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Affiliation(s)
- Mark Noar
- Heartburn & Reflux Study Center, Endoscopic Microsurgery Associates PA, 7402 York Road 100, Towson, MD, 21204, USA,
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Woodland P, Amarasinghe G, Sifrim D. Emerging therapeutic options in GERD. Best Pract Res Clin Gastroenterol 2013; 27:455-67. [PMID: 23998982 DOI: 10.1016/j.bpg.2013.06.006] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/29/2013] [Revised: 06/16/2013] [Accepted: 06/23/2013] [Indexed: 01/31/2023]
Abstract
Gastroesophageal reflux disease (GERD) is a prevalent problem resulting in a high level of healthcare consultation and expenditure in the Western World. Although standard medical therapy (in the form of proton pump inhibitor drugs) is effective in the majority of cases, there remains a significant proportion who are refractory to treatment. In addition, surgical therapy (in the form of laparoscopic fundoplication) is not always effective, and in some can be associated with significant side-effects, particularly gas-bloat, flatulence and dysphagia. As such there remains an unmet need in GERD to develop new therapies for refractory cases, and to develop alternatives to fundoplication with fewer side-effects. This article discusses the current state of pharmacological and non-pharmacological emerging therapies for GERD.
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Affiliation(s)
- Philip Woodland
- Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK
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Khajanchee YS, Cassera MA, Swanström LL, Dunst CM. Diagnosis of Type-I hiatal hernia: a comparison of high-resolution manometry and endoscopy. Dis Esophagus 2013; 26:1-6. [PMID: 22320417 DOI: 10.1111/j.1442-2050.2011.01314.x] [Citation(s) in RCA: 30] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
Sliding Type-I hiatal hernia is commonly diagnosed using upper endoscopy, barium swallow or less commonly, esophageal manometry. Current data suggest that endoscopy is superior to barium swallow or esophageal manometry. Recently, high-resolution manometry has become available for the assessment of esophageal motility. This novel technology is capable of displaying spatial and topographic pressure profiles of gastroesophageal junction and crural diaphragm in real time. The objective of the current study was to compare the specificity and sensitivity of high-resolution manometry and endoscopy in the diagnosis of sliding hiatal hernia in patients with gastroesophageal reflux disease. Data were analyzed retrospectively for 83 consecutive patients (61% females, mean age 52 ± 13.2 years) with objective gastroesophageal reflux disease who were considered for laparoscopic antireflux surgery between January 2006 and January 2009 and had preoperative high-resolution manometry and endoscopy. Manometrically, hiatal hernia was defined as separation of the gastroesophageal junction >2.0 cm from the crural diaphragm. Intraoperative diagnosis of hiatal hernia was used as the gold standard. Sensitivity, specificity and likelihood ratios of a positive test and a negative test were used to compare the performance of the two diagnostic modalities. Forty-two patients were found to have a Type-I sliding hiatal hernia (>2 cm) during surgery. Twenty-two patients had manometric criteria for a hiatal hernia by high-resolution manometry, and 36 patients were described as having a hiatal hernia by preoperative endoscopy. False positive results were significantly fewer (higher specificity) with high-resolution manometry as compared with endoscopy (4.88% vs. 31.71%, P= 0.01). There were no significant differences in the false negative results (sensitivity) between the two diagnostic modalities (47.62% vs. 45.24%, P= 0.62). Analysis of likelihood ratios of a positive and negative test demonstrated that high-resolution manometry is better than endoscopy both to rule out and rule in a hiatal hernia. A significant discordance was also observed between the two tests (P= 0.033). High-resolution manometry has better specificity and ability to rule out an overt Type-I sliding hiatal hernia (greater likelihood ratio of a positive test) in patients with GERD. Because of high false negative results, both high-resolution manometry and endoscopy are unreliable for ruling in a hiatal hernia. Negative result for a hiatal hernia by either modality mandates additional testing.
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Affiliation(s)
- Y S Khajanchee
- Gastrointestinal and Minimally Invasive Surgery Division, The Oregon Clinic, 4805 NE Glisan Street, Portland,OR 97213, USA
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Radiofrequency energy delivery to the lower esophageal sphincter reduces esophageal acid exposure and improves GERD symptoms: a systematic review and meta-analysis. Surg Laparosc Endosc Percutan Tech 2012; 22:283-8. [PMID: 22874675 DOI: 10.1097/sle.0b013e3182582e92] [Citation(s) in RCA: 65] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
PURPOSE Studies of endoscopic application of radiofrequency energy to the lower esophageal sphincter for gastroesophageal reflux control have produced conflicting reports of its effectiveness. This study aimed to conduct a meta-analysis of randomized controlled trials and cohort studies to assess the impact of this treatment. METHODS Twenty studies were included. Outcomes analyzed included gastroesophageal reflux disease (GERD) symptom assessment, quality of life, esophageal pH, and esophageal manometry. RESULTS A total of 1441 patients from 18 studies were included. Radiofrequency treatment improved heartburn scores (P=0.001), and produced improvements in quality of life as measured by GERD-health-related quality-of-life scale (P=0.001) and quality of life in reflux and dyspepsia score (P=0.001). Esophageal acid exposure decreased from a preprocedure Johnson-DeMeester score of 44.4 to 28.5 (P=0.007). CONCLUSIONS Radiofrequency ablation of the lower esophageal sphincter produces significant improvement in reflux symptoms and may represent an alternative to medical treatment and surgical fundoplication in select patients.
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Long-Term Results of Radiofrequency Energy Delivery for the Treatment of GERD: Results of a Prospective 48-Month Study. DIAGNOSTIC AND THERAPEUTIC ENDOSCOPY 2011; 2011:507157. [PMID: 22110288 PMCID: PMC3202130 DOI: 10.1155/2011/507157] [Citation(s) in RCA: 29] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 01/17/2011] [Revised: 06/18/2011] [Accepted: 08/17/2011] [Indexed: 12/17/2022]
Abstract
Since 2000, radiofrequency (RF) energy treatment has been increasingly offered as an alternative option to invasive surgical procedures for selected patients with gastroesophageal reflux disease (GERD). Out of 69 patients treated since June 2002 to December 2007 with the Stretta procedure, 56 of them reached by the end of 2010 a 48-month followup. RF treatment significantly improved heartburn scores, GERD-specific quality of life scores, and general quality of life scores at 24 and 48 months in 52 out of 56 patients (92,8%). At each control time both mean heartburn and GERD HRQL scores decreased (P = 0.001 and P = 0.003, resp.) and both mental SF-36 and physical SF-36 ameliorated (P = 0.001 and 0.05, resp.). At 48 months, 41 out of 56 patients (72,3%) were completely off PPIs. Morbidity was minimal, with only one relevant but transient complication.
According to other literature data, this study shows that RF delivery to LES is safe and durably improves symptoms and quality of life in well-selected GERD patients.
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Chen D, Barber C, McLoughlin P, Thavaneswaran P, Jamieson GG, Maddern GJ. Systematic review of endoscopic treatments for gastro-oesophageal reflux disease. Br J Surg 2009; 96:128-36. [PMID: 19160349 DOI: 10.1002/bjs.6440] [Citation(s) in RCA: 46] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
BACKGROUND The aim of this review was to assess the safety and efficacy of endoscopic procedures for gastro-oesophageal reflux disease. METHODS Literature databases including Medline, Embase and PubMed were searched up to May 2006 without language restriction. Randomized controlled trials and non-randomized comparative studies with at least ten patients in each study arm, and case series studies of at least ten patients, were included. RESULTS A total of 33 studies examining seven endoscopic procedures (Stretta procedure, Bard EndoCinch, Wilson-Cook Endoscopic Suturing Device, NDO Plicator, Enteryx, Gatekeeper Reflux Repair System and Plexiglas) were included in the review. Of the three procedures that were tested against sham controls (Stretta procedure, Bard EndoCinch and Enteryx), patient outcomes in the treatment group were either as good as, or significantly better than, those of control patients in terms of heartburn symptoms, quality of life and medication usage. However, for the two procedures that were tested against laparoscopic fundoplication (Stretta) procedure and Bard EndoCinch), outcomes for patients in the endoscopic group were either as good as, or inferior to, those for the laparoscopic group. CONCLUSION At present there is insufficient evidence to determine the safety and efficacy of endoscopic procedures for gastro-oesophageal reflux disease, particularly in the long term.
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Affiliation(s)
- D Chen
- Department of Surgery, University of Adelaide and The Queen Elizabeth Hospital, South Australia, Australia
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Poignet P, Chemori A, Zemiti N, Liu C. Some control-related issues in mini-robotics for endoluminal surgery. ANNUAL INTERNATIONAL CONFERENCE OF THE IEEE ENGINEERING IN MEDICINE AND BIOLOGY SOCIETY. IEEE ENGINEERING IN MEDICINE AND BIOLOGY SOCIETY. ANNUAL INTERNATIONAL CONFERENCE 2009; 2009:6850-6855. [PMID: 19964182 DOI: 10.1109/iembs.2009.5333117] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 05/28/2023]
Abstract
This paper introduces some issues related to the development of robotics for endoluminal surgery from control point of view. Endoluminal surgery are incisionless procedures performed through natural orifices within the natural pathways. New devices are then required to achieve these new surgical procedures. Besides the development of new devices, control issues arise in both technological and theoretical aspects. The paper presents some of them and we propose a teleoperation architecture that has already been tested for needle insertion that could be used for teleoperated endoluminal surgery especially for instance for biopsies or anastomoses.
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Affiliation(s)
- Philippe Poignet
- LIRMM, UMR 5506, Univ. Montpellier 2-CNRS, 161 Rue Ada, 34392 Montpellier, France.
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The Stretta procedure versus proton pump inhibitors and laparoscopic Nissen fundoplication in the management of gastroesophageal reflux disease: a cost-effectiveness analysis. CANADIAN JOURNAL OF GASTROENTEROLOGY = JOURNAL CANADIEN DE GASTROENTEROLOGIE 2008; 22:552-8. [PMID: 18560633 DOI: 10.1155/2008/765458] [Citation(s) in RCA: 27] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
BACKGROUND The Stretta procedure is an endoscopic therapy for gastroesophageal reflux disease. OBJECTIVE To evaluate the cost-effectiveness of the Stretta procedure and that of competing strategies in the long-term management of gastroesophageal reflux disease. METHODS A Markov model was designed to estimate costs and health outcomes in Canadian patients with gastroesophageal reflux disease over five years, from a Ministry of Health perspective. Strategies included the use of daily proton pump inhibitors (PPIs), laparoscopic Nissen fundoplication (LNF) and the Stretta procedure. Probabilities and utilities were derived from the literature. Costs are expressed in 2006 Canadian dollars. Units of effectiveness were symptom-free months (SFMs) and quality-adjusted life years (QALYs), using a five-year time horizon. RESULTS In the analysis that used SFMs, the strategy using PPIs exhibited the lowest costs ($40 per SFM) and the greatest number of SFMs, thus dominating both the LNF and Stretta systems. But the cost-effectiveness analysis using QALYs as the measure of effectiveness showed that PPIs presented the lowest cost-effectiveness ratio, while both the LNF and Stretta strategies were associated with very high incremental costs (approximately $353,000 and $393,000, respectively) to achieve an additional QALY. However, the PPI strategy did not dominate the two other strategies, which were associated with better effectiveness. CONCLUSIONS If SFMs are used as the measure of effectiveness, PPIs dominate the Stretta and LNF strategies. However, if QALYs are used, the PPIs still present the lowest cost and LNF gives the best effectiveness. Regardless of the units of effectiveness or utility used in the present cost analysis, an approach of prescribing PPIs appears to be the preferred strategy.
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Affiliation(s)
- Brian R Davis
- Department of Surgery, University of Louisville School of Medicine, Louisville, KY 40292, USA
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Dundon JM, Davis SS, Hazey JW, Narula V, Muscarella P, Melvin WS. Radiofrequency energy delivery to the lower esophageal sphincter (Stretta procedure) does not provide long-term symptom control. Surg Innov 2008; 15:297-301. [PMID: 18829607 DOI: 10.1177/1553350608324508] [Citation(s) in RCA: 15] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
The Stretta procedure (radiofrequency energy application to the lower esophageal sphincter) is a unique endoluminal technique for the management of gastroesophageal reflux. This article reports on the long-term effectiveness of the Stretta procedure in patients with significant gastroesophageal reflux disease (GERD) referred to a surgical practice. Patients who underwent Stretta with a minimum of 36 months follow-up were included. Thirty-two patients with an average follow-up of 53 months were included; 19 proceeded to anti-reflux surgery. Those not undergoing surgery showed a significant improvement in their GERD satisfaction from 3.14 to 1.46 (P = .0006) but had significantly lower preprocedure heartburn scores (2.43) than those who proceeded to surgery (3.66, P = .0401). The Stretta procedure was effective in reducing symptoms in 40% of patients. Responders had less severe preoperative heartburn. Radiofrequency energy delivery to the lower esophageal sphincter may be effective in selected patients for the treatment of gastroesophageal reflux.
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Affiliation(s)
- John M Dundon
- Center for Minimally Invasive Surgery, Department of Surgery, The Ohio State University, Columbus 43210, USA
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Combined transabdominal gastroplasty and fundoplication for shortened esophagus: impact on reflux-related and overall quality of life. Ann Thorac Surg 2008; 85:1947-52. [PMID: 18498800 DOI: 10.1016/j.athoracsur.2008.02.080] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/06/2006] [Revised: 02/27/2008] [Accepted: 02/28/2008] [Indexed: 11/23/2022]
Abstract
BACKGROUND Transabdominal gastroplasty for shortened esophagus at the time of fundoplication results in a segment of aperistaltic, acid-secreting neoesophagus above the fundoplication. We hypothesized that transabdominal gastroplasty impairs quality of life (QOL). METHODS This was a matched paired analysis with retrospective chart review and follow-up questionnaire of 116 patients undergoing transabdominal fundoplication with gastroplasty with 116 matched controls undergoing transabdominal fundoplication alone from January 1997 to June 2005. Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36) and Quality Of Life in Reflux And Dyspepsia (QOLRAD) instruments were used to measure overall and reflux-related QOL. Overall response rate was 75%; including 65 matched pairs used for long-term follow-up and QOL analysis. RESULTS Groups were similar in age, sex, duration of hospitalization, and complications (p > 0.05). Gastroplasty patients had larger hiatal hernias and were more likely to have undergone a previous fundoplication (p < 0.01). No perioperative deaths or major morbidity occurred in 18% of both groups. Survey respondents were older than nonrespondents (p < 0.01). Complications did not impact response rates (p = 0.11). Median follow-up was 14 months in the gastroplasty group and 17 months in controls (p = 0.02). The groups had similar scores on the SF-36 and QOLRAD (p > 0.05) and similar overall frequency of patient satisfaction, perceived health status, and self-reported symptoms of reflux, dysphagia, bloating, diarrhea, and excessive flatus (p > 0.05). Control patients were more likely to require rehospitalization or reinterventions (p = 0.04). CONCLUSIONS Transabdominal gastroplasty and fundoplication for shortened esophagus is safe and results in similar overall and reflux-related QOL compared with fundoplication alone.
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Gastroparesis associated with gastroesophageal reflux disease and corresponding reflux symptoms may be corrected by radiofrequency ablation of the cardia and esophagogastric junction. Surg Endosc 2008; 22:2440-4. [PMID: 18437485 DOI: 10.1007/s00464-008-9873-4] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/18/2007] [Revised: 08/21/2007] [Accepted: 11/28/2007] [Indexed: 10/22/2022]
Abstract
BACKGROUND Reflux is a common medical condition with symptoms ordinarily controlled using drug/medical therapy. However, 20% of patients experience unmanageable symptoms despite twice-daily (BID) proton pump inhibitor (PPI) therapy. Growing clinical evidence shows that delayed gastric emptying (gastroparesis) may be a factor associated with severe reflux, dyspepsia, or both. Gastroparesis, concomitant in 25% of patients with gastroesophageal reflux disease (GERD), has been shown to improve after Nissen fundoplication. Radiofrequency treatment for GERD potentially corrects GERD-associated gastroparesis and resultant PPI BID reflux failures. METHODS From July 2000 until July 2004, 227 patients undergoing Stretta for GERD were screened for gastric anomalies. Patients with gastroparesis, documented on a standardized nuclear gastric emptying scans, and patients with heartburn and regurgitation uncontrolled by PPI BID medications underwent radiofrequency ablation of the cardia and esophagogastric junction via the Stretta procedure. The patients had esophagogastroduodenoscopy and/or pH studies, manometry, solid-phase gastric emptying, and electrogastrography and completed standardized heartburn and health-related quality-of-life surveys before treatment, then 6 months afterward. Patients with pyloric obstruction and those taking motility agents were excluded from the study. Gastric emptying scans were repeated 6 months after Stretta. The nuclear radiologist was blinded to the study design. RESULTS At baseline, 31 patients were classified as abnormal. At 6 months after the procedure, emptying scores had improved significantly, with the percentage of solid food emptied at 90 min improved from 41% to 66% (p < 0.0001) and at 120 minutes from 55% to 84%. Significant improvements were seen at all intervals. Overall, 23 patients (74%) experienced normalization of gastric emptying, and 4 patients were improved but remained abnormal. Four patients showed no improvement on their gastric emptying scans, with one patient electing to undergo a Nissen procedure. All the patients had a 1-year symptom follow-up assessment, which showed significant improvements in GERD health-related quality of life, dyspepsia, and heartburn scores. CONCLUSIONS Radiofrequency treatment has been demonstrated to correct gastroparesis. Patients' symptoms improved significantly. The mechanism of action is unknown but may be related to reduction in transient lower esophageal sphincter relaxations (TLESRs), increased esophagogastric junction barrier, decreased esophageal venting, alteration of the gastric pacemaker function in the region of radiofrequency therapy administration, removal of medications for symptoms, or a combination of all these.
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Reavis KM, Melvin WS. Advanced endoscopic technologies. Surg Endosc 2008; 22:1533-46. [PMID: 18401657 DOI: 10.1007/s00464-008-9831-1] [Citation(s) in RCA: 34] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/21/2007] [Accepted: 02/04/2008] [Indexed: 12/20/2022]
Abstract
The use of endoscopy for diagnosing and treating ailments of the alimentary tract has evolved steadily over the past few decades, with tremendous growth and innovation in the past few years. Initially, endoscopy relied on rigid telescopes, direct visualization, and dangerously exothermic sources of illumination. The introduction of fiber optics, charge-coupled-device cameras, and increasingly efficient light sources has enabled researchers to investigate areas of the human gastrointestinal tract through flexible endoscopy not previously thought to be reachable without formal surgical exploration. The more recent advances in scope platforms, devices, and techniques have allowed researchers to push the envelope of endoscopic diagnostics and therapeutics to greater heights. Specific new platforms include ColonoSight and mother-daughter endoscopes such as the ShapeLock TransPort and the SpyGlass direct visualization system. Specific devices include the EndoCinch suturing system, the full-thickness Plicator procedure, Esophyx, the Stretta system, and the HALO(360) system. Specific new techniques include small-caliber endoscopy, endoscopic mucosal and submucosal resection, and natural orifice translumenal endoscopic surgery (NOTES). This article describes the most relevant recent advances in endoscopic innovation with regard to platform design, devices, and techniques anticipated to serve as the foundation for further research and design for developing generations of endoscopic technologies to come.
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Affiliation(s)
- Kevin M Reavis
- Division of General Surgery, The Ohio State University, RM N 729 Doan Hall, 410 W. Tenth Avenue, Columbus, OH 43210, USA.
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Abstract
Today, there are several modalities to treat gastroesophageal reflux disease (GERD) (medications, endoscopic therapies, surgery) and such therapies can be used either singly, or in tandem, or in combination with the others, aiming at "normalization" of the patient's GERD-related quality of life and, if possible, esophageal acid exposure. Several intermediate end points or clinically significant outcomes have not been reached by some therapeutic modalities and no single modality is or can be perfect. Statistically significant improvements in these intermediate end points have been shown in "some" but not all studies. Although healing of esophagitis can be accomplished with either medical or surgical therapy, there is inadequate data with endotherapies, because most patients treated with endotherapies have had prior trials of proton pump inhibitors (PPIs) and hence healed their esophagitis. Effective prevention of complications, such as esophageal adenocarcinoma, remains challenging for all modalities. Patients who have not normalized their GERD-related quality of life with once or twice daily PPI therapy should undergo functional esophageal evaluation with pH testing and esophageal motility study and they should be evaluated by both an endoscopist and a surgeon. The decision on how to proceed should be made on the basis of the criteria for endotherapy and surgery, availability of local endoscopic and surgical expertise and patients' preference. Such multimodality therapy model is in many ways similar to the long-term management of coronary artery disease where pharmacotherapy, angioplasty, and bypass surgery are frequently used in tandem or in combination. Multimodality therapy aiming at normalization of GERD-related quality of life is an option today, and should be available to all patients in need of therapy. The target population for GERD endotherapy currently consists of PPI-dependent GERD patients, who have a small (<2-cm-long) or no sliding hiatal hernia, and without severe esophagitis or Barrett esophagus. Thus far, only Stretta and the NDO plicator have been studied in sham-controlled trials. Registries of complications suggest that these techniques are relatively safe, but serious morbidity, including rare mortality have been reported (for a continuous update on complications related to endoscopic therapies see: http://www.fda.gov/cdrh/maude.html). All can be performed on an outpatient basis, under intravenous sedation and local pharyngeal anesthesia. Future comparative studies with predetermined clinically significant end points, validated outcome measures, prolonged follow-up, and complete complication registries will eventually determine the precise role of endoscopic procedures for the patients with GERD.
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Affiliation(s)
- George Triadafilopoulos
- Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Stanford, CA 94305-5187, USA.
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Torquati A, Richards WO. Endoluminal GERD treatments: critical appraisal of current literature with evidence-based medicine instruments. Surg Endosc 2007; 21:697-706. [PMID: 17401603 DOI: 10.1007/s00464-007-9344-3] [Citation(s) in RCA: 19] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/13/2007] [Accepted: 02/13/2007] [Indexed: 12/12/2022]
Abstract
BACKGROUND The literature of endoluminal treatment of gastroesophageal reflux disease (GERD) widely varies in the level of evidence presented for analysis. Therefore there is a need for a comprehensive evidence-based medicine (EBM) analysis of the current literature evidence of the three FDA-approved modalities used for endoluminal treatment of GERD. SEARCH STRATEGY In January 2007, the MEDLINE database was searched for randomized controlled trials (RCTs), and controlled clinical trials of currently available endoluminal treatment of GERD. Database searches combined the specific endoluminal device keywords with the condition-specific keyword (e.g., GERD). DATA COLLECTION AND ANALYSIS All relevant studies have been categorized according to the evidence they provide according to the guidelines for Levels of Evidence and Grades of Recommendation supplied by the Oxford Centre for Evidence-Based Medicine. MAIN RESULTS AND AUTHORS' CONCLUSION: Sixteen studies met the inclusion criteria, representing 787 patients. The methodological quality of most of the included studies was average; four studies were grade 1b (individual randomized trial), 10 were grade 2b (individual cohort study), and two were grade 3b (individual case-control study) There is grade 1b and 2b evidence demonstrating the EndoCinch plication is effective in reducing GERD symptoms at short-term follow up. However, in the majority of the studies analyzed, the procedure does not significantly reduce the acid exposure in the distal esophagus. The majority of the studies with long-term outcome showed disappointing outcomes, probably due to suture loss in the majority of patients. There is grade 1b and 2b evidence demonstrating that the Stretta procedure is effective in reducing GERD symptoms at short- and mid-term follow up. However, in the majority of the studies analyzed, the procedure did not reduce significantly the acid exposure in the distal esophagus. There is grade 1b and 2b evidence demonstrating that full-thickness plication is effective in reducing GERD symptoms, and acid exposure in the distal esophagus.
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Affiliation(s)
- Alfonso Torquati
- Department of Surgery, Vanderbilt University School of Medicine, Nashville, TN, USA
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Reymunde A, Santiago N. Long-term results of radiofrequency energy delivery for the treatment of GERD: sustained improvements in symptoms, quality of life, and drug use at 4-year follow-up. Gastrointest Endosc 2007; 65:361-6. [PMID: 17321231 DOI: 10.1016/j.gie.2006.06.036] [Citation(s) in RCA: 56] [Impact Index Per Article: 3.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/02/2006] [Accepted: 06/05/2006] [Indexed: 02/08/2023]
Abstract
BACKGROUND The Stretta endoscopic antireflux procedure has effectively controlled symptoms of patients with GERD refractory to proton pump inhibitor (PPI) medication up to 1 year. OBJECTIVE The aim of this study was to evaluate the efficacy of the Stretta procedure for patients with GERD based on symptom control, quality of life (QOL), and medication use. DESIGN Prospective single-center case series. SETTING Academic endoscopy referral center. PATIENTS Adults with GERD symptoms and partial response to daily antisecretory medication. INTERVENTION We have used the Stretta procedure for patients with GERD diagnosed by endoscopic or pH testing since 2000. Our primary assessment was a validated health-related QOL score for heartburn and regurgitation and GERD symptoms index performed at baseline, 12, 36, and 48 months after treatment. A secondary outcome measure was the dose and the frequency of antisecretory pharmaceutical use. RESULTS We performed the Stretta procedure in 83 consecutive patients with persistent GERD symptoms. Complete matched data for follow-up evaluations are reported at 12, 36, and 48 months. The mean GERD QOL score was 2.4 (baseline), 4.6 (36 months), and 4.3 (48 months, P < .001). The mean GERD symptom score was 2.7 (baseline), 0.3 (36 months), and 0.6 (48 months P < .001). Daily medication usage was 100% (baseline) and 13.6% (48 months, P < .001). LIMITATIONS Nonrandomized study design, lack of control arm, and lack of 24-hour pH. CONCLUSIONS For these GERD patients followed to 4 years, the Stretta procedure was a safe, effective, and durable treatment, with significant and sustained improvements in GERD symptoms, QOL, and PPI elimination.
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Affiliation(s)
- Alvaro Reymunde
- Gastroenterology Section, Ponce Gastroenterology Research, Damas Hospital, Ponce, Puerto Rico 00731, USA
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Noar MD, Lotfi-Emran S. Sustained improvement in symptoms of GERD and antisecretory drug use: 4-year follow-up of the Stretta procedure. Gastrointest Endosc 2007; 65:367-72. [PMID: 17321232 DOI: 10.1016/j.gie.2006.11.015] [Citation(s) in RCA: 51] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/24/2006] [Accepted: 11/04/2006] [Indexed: 02/08/2023]
Abstract
BACKGROUND Approximately 20% of patients with GERD do not respond to medical therapy. The Stretta radiofrequency antireflux procedure represents an alternative to failed drug therapy for GERD. OBJECTIVE The aim of this study was to assess symptom and medication changes after the Stretta procedure during a 4-year follow-up period. DESIGN Prospective case series on intent-to-treat basis. SETTING Community practice. PATIENTS Patients with GERD with persistent symptoms despite twice-daily proton pump inhibitor (PPI) medications. INTERVENTIONS The Stretta procedure was performed in drug-refractory patients with GERD diagnosed by the presence of endoscopically evidenced esophagitis or abnormal esophageal pH testing. Symptom assessment was performed with a validated health-related quality-of-life questionnaire (with and without medication) at baseline and 6, 12, 24, 36, and 48 months after treatment. Complications of the procedure and medication usage were analyzed. MAIN OUTCOME MEASUREMENTS Significant changes in symptom scores, GERD quality-of-life parameters, and medication usage on the basis of clinical outcomes. RESULTS We report on a series of 109 consecutive patients treated with the Stretta procedure who have reached 4-year follow-up. Complete long-term follow-up assessment was available in matched data for 109 patients at 12 months, 108 patients at 24 months, 102 patients at 36 months, and 96 patients at 48 months. A second procedure was performed in 13 patients. Heartburn scores decreased from 3.6 to 1.18 (P < .001), total heartburn score (GERD health-related quality-of-life questionnaire) decreased from 27.8 to 7.1 (P < .001), and patient satisfaction improved from 1.4 to 3.8 (P < .001) (see ). Medication usage decreased significantly from 100% of patients on twice-daily PPI therapy at baseline to 75% of patients showing elimination of medications or only as-needed use of antacids/over-the-counter PPIs at 48 months (P < 0.005). There were no serious complications of the procedure. LIMITATIONS This is an uncontrolled, nonrandomized case series in consecutive patients that does not include long-term pH or motility studies. CONCLUSIONS This study in drug-refractory patients with GERD found the Stretta procedure to be a safe, effective, and durable treatment that produced significant improvements in heartburn and quality of life and decreased medication usage during a 4-year period of follow-up.
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Affiliation(s)
- Mark D Noar
- Heartburn and Reflux Study Center, Endoscopic Microsurgery Associates, 7402 York Road, Towson, MD 21204, USA
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Morgenthal CB, Richards WO, Dunkin BJ, Forde KA, Vitale G, Lin E. The role of the surgeon in the evolution of flexible endoscopy. Surg Endosc 2006; 21:838-53. [PMID: 17180263 DOI: 10.1007/s00464-006-9109-4] [Citation(s) in RCA: 26] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/24/2006] [Accepted: 09/22/2006] [Indexed: 12/15/2022]
Abstract
Several cultures, including the Egyptians, Greeks, Romans, and Arabs, made attempts to view accessible human body cavities using a variety of instruments such as spatulas and specula. The first endoscope was created in 1806 when Phillip Bozzini, a German-born urologist, constructed the lichtleiter, which used concave mirrors to reflect candlelight through an open tube into the esophagus, bladder, or rectum. Maximilian Carl-Friedrich Nitze, another German urologist, produced the first usable cystoscope in 1877 by using series of lenses to increase magnification. He was also the first to place light inside the organ of interest to aid visualization. In 1880 Mikulicz made the first gastroscope using a system similar to Nitze's cystoscope. Modern endoscopy was born with the introduction of the fiberoptic endoscope in the late 1950s. Over the ensuing 50 years endoscopy revolutionized many aspects of the surgeon's practice. Endoscopy can now be used to diagnose and often treat gastrointestinal cancer, hemorrhage, obstruction, and inflammatory conditions. This review was initiated by the SAGES Flexible Endoscopy Committee to chronicle the role of the surgeon in the development and introduction of flexible endoscopy into clinical practice, historically and in contemporary surgery. Flexible endoscopy evolved out of surgeons' need to overcome diagnostic and therapeutic challenges. There have been many recent technological advances that facilitate endoluminal therapies, and flexible endoscopy is now traversing new ground. Surgeons have been major contributors in the development of all aspects of endoscopy. There is a continually expanding list of therapeutic options available to patients. The difficult questions of which procedure, on which patient, and when can be answered best by the surgeon versed in endoscopic, laparoscopic, and open surgical techniques.
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Affiliation(s)
- C B Morgenthal
- Endosurgery Unit, Department of Surgery, Emory University School of Medicine, Atlanta, Georgia 30322, USA
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Youssef YK, Shekar N, Lutfi R, Richards WO, Torquati A. Long-term evaluation of patient satisfaction and reflux symptoms after laparoscopic fundoplication with Collis gastroplasty. Surg Endosc 2006; 20:1702-5. [PMID: 16960664 DOI: 10.1007/s00464-006-0048-x] [Citation(s) in RCA: 23] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/13/2006] [Accepted: 04/11/2006] [Indexed: 10/24/2022]
Abstract
BACKGROUND Esophageal shortening is a complication of advanced gastroesophageal reflux disease (GERD). For patients with short esophagus, Collis gastroplasty combined with fundoplication provides excellent symptomatic relief from GERD disease. The literature lacks studies comparing satisfaction and reflux symptoms between patients who underwent Nissen fundoplication with Collis gastroplasty and those who had primary fundoplication alone. This study aimed to assess long-term satisfaction and GERD-related quality of life after laparoscopic Collis-Nissen fundoplication, and to compare them with those for Nissen fundoplication alone. METHODS A nested case-control study was conducted. In this study, 14 cases of laparoscopic Collis-Nissen fundoplications were matched for age, gender, and length of the follow-up period to a cohort of 120 control subjects who underwent laparoscopic Nissen fundoplication. All the patients were mailed a follow-up survey which included a Short Form-12 (SF-12) health status (quality-of-life) questionnaire (a validated quality-of-life instrument), a Quality of Life in Reflux and Dyspepsia (QOLRAD) questionnaire (a GERD-specific quality-of-life instrument), and queries regarding long-term satisfaction and medication use. RESULTS Both groups showed a significant postoperative increase in QOLRAD mean scores (p = 0.01). However, the difference in the delta (postoperative-preoperative) score between the two groups was not significant (Fig. 1). There were no differences in mental (MCS) or physical (PCS) SF-12 scores between the two groups. The rate of satisfaction with the surgery was similar in the Nissen-Collis fundoplication (87.5%) and Nissen fundoplication (87%) groups. CONCLUSIONS Collis gastroplasty combined with Nissen fundoplication is an effective procedure for patients with a shortened esophagus diagnosed intraoperatively during antireflux surgery. Patient satisfaction, postoperative quality of life, and QOLRAD score improvement after this procedure are comparable with those observed in patients treated with Nissen fundoplication alone.
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Affiliation(s)
- Y K Youssef
- Department of Surgery, Vanderbilt University School of Medicine, D-5203 MCN, Nashville, TN 37232-2577, USA
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Iqbal A, Salinas V, Filipi CJ. Endoscopic therapies of gastroesophageal reflux disease. World J Gastroenterol 2006; 12:2641-55. [PMID: 16718747 PMCID: PMC4130969 DOI: 10.3748/wjg.v12.i17.2641] [Citation(s) in RCA: 18] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/08/2005] [Revised: 08/13/2006] [Accepted: 08/30/2005] [Indexed: 02/06/2023] Open
Abstract
The high prevalence of gastroesophageal reflux disease (GERD) in Western societies has accelerated the need for new modalities of treatment. Currently, medical and surgical therapies are widely accepted among patients and physicians. New potent antisecretory drugs and the development of minimally invasive surgery for the management of GERD are at present the pivotal and largely accepted approaches to treatment. The minimally invasive treatment revolution, however, has stimulated several new endoscopic techniques for GERD. Up to now, the data is limited and further studies are necessary to compare the advantages and disadvantages of the various endoscopic techniques to medical and laparoscopic management of GERD. New journal articles and abstracts are continuously being published. The Food and Drug Administration has approved 3 modalities, thus gastroenterologists and surgeons are beginning to apply these techniques. Further trials and device refinements will assist clinicians. This article will present an overview of the various techniques that are currently on study. This review will report the efficacy and durability of various endoscopic therapies for gastroesophageal reflux disease (GERD). The potential for widespread use of these techniques will also be discussed. Articles and abstracts published in English on this topic were retrieved from Pubmed. Due to limited number of studies and remarkable differences between various trials, strict criteria were not used for the pooled data presented, however, an effort was made to avoid bias by including only studies that used off-PPI scoring as baseline and intent to treat.
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Affiliation(s)
- Atif Iqbal
- Department of Surgery, University of Missouri Columbia, One Hospital Drive, 65211, USA
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Canon CL, Morgan DE, Einstein DM, Herts BR, Hawn MT, Johnson LF. Surgical approach to gastroesophageal reflux disease: what the radiologist needs to know. Radiographics 2006; 25:1485-99. [PMID: 16284130 DOI: 10.1148/rg.256055016] [Citation(s) in RCA: 38] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
Gastroesophageal reflux disease (GERD) is defined as gastroesophageal reflux resulting in symptoms or in injury to the esophageal epithelium. Although the medical management of GERD has improved, an increasing number of laparoscopic antireflux surgical procedures are being performed. Barium studies, endoscopy, manometry, and pH monitoring are all integral components of preoperative evaluation. Barium swallow examination must allow critical evaluation of esophageal peristalsis, the presence and extent of gastroesophageal reflux, and complications including esophagitis, stricture, and Barrett esophagus. It is crucial to identify and characterize hiatal hernia and longitudinal stricture, which can result in a shortened esophagus. In such cases, it becomes necessary for the surgeon to incorporate an esophageal lengthening procedure prior to fundoplication; otherwise, poor surgical outcome is likely. Normal postfundoplication radiographic findings as well as postoperative complications (eg, tight wrap, perforation, abscess, complete or partial dehiscence, recurrent stricture, recurrent hernia, intrathoracic migration of the wrap) must also be recognized and clearly understood by the radiologist. Given the chronic nature and prevalence of symptomatic GERD and the increasing number of patients undergoing surgical intervention, it is imperative that the radiologist understand the pre- and postsurgical evaluation of affected patients.
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Affiliation(s)
- Cheri L Canon
- Division of Gastroenterology, Department of Radiology, University of Alabama, Birmingham, AL 35249-6830, USA.
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Vitale GC, Davis BR, Tran TC. The advancing art and science of endoscopy. Am J Surg 2005; 190:228-33. [PMID: 16023436 DOI: 10.1016/j.amjsurg.2005.05.017] [Citation(s) in RCA: 30] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [MESH Headings] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/13/2005] [Accepted: 04/15/2005] [Indexed: 11/22/2022]
Abstract
Flexible endoscopy continues to advance encompassing treatment of a variety of diseases traditionally managed surgically. This review describes and evaluates many of these new endoscopic approaches with an eye toward the future. Gastroesophageal reflux disease is now treated with several endoscopic, non-operative techniques. A procedure using radiofrequency energy delivered by a peroral catheter with small needles inserted into the wall of the esophagus causes collagen deposition and ablates transient lower esophageal sphincter relaxation, both of which reduce reflux. With this treatment, >80% of patients will reduce or stop their medication for reflux. Trials involving new injectable materials show promise with a 75-80% improvement in heartburn-related quality-of-life scores and reduced medication use. Endoscopic suture and stapling devices restore the antireflux barrier with sutures that create a pleat or plication at the gastroesophageal junction. Early results indicated that 62-74% of patients had significant improvement. Long-term results are not available for any of these new techniques and there seems to be a drop off in effectiveness over time. Gastrointestinal bleeding has been more effectively managed with the recent introduction of small clips and detachable snares to control bleeding vessels. Banding and sclerotherapy for variceal bleeding has all but eliminated urgent operation for that diagnosis. In the biliary-pancreas realm, endoscopic management of pancreatic pseudocysts, stenting of pancreatic or biliary strictures and fistulae have reduced operative indications in those disease processes. Pseudocyst drainage involves creation of a transenteric communication between the pseudocyst and the stomach or duodenum. Complete cyst resolution without recurrence can be expected in 85% of patients. While endoscopic palliation of malignant biliary strictures has been accepted for years, experience with endoscopic management of iatrogenic strictures indicates that it may serve as an alternative option without surgery in many patients. Enteric stenting using metallic self-expanding stents in the esophagus, duodenum, and colon allows alleviation of obstruction without surgery for palliantation and in the colon may relieve obstruction to avoid colostomy prior to an elective resection. On the horizon stands the flexible endoscopic route to the abdominal cavity via the transgastric route and the promise of combined endoscopic-laparoscopic approaches to complex abdominal problems. General surgeons should rekindle their interest in flexible endoscopy or risk losing entire categories of disease to other specialties or to a small specialized group of endoscopic surgeons.
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Affiliation(s)
- Gary C Vitale
- Department of Surgery, University of Louisville School of Medicine, Louisville, KY 40292, USA.
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Abstract
The Stretta procedure is safe and effective for the treatment of GERD. There are well-documented clinical trial data supporting its use, including a randomized sham-controlled study, single- and multi-center prospective trials, and community practice reports. The complication rate is within the acceptable range for therapeutic endoscopic procedures and less than the published complication rate for laparoscopic fundoplication. The durability of effect also is established beyond 2 years in several studies. Stretta should be added to the GERD management algorithm specifically for patients considering an antireflux surgical procedure but who are not accepting of the risks of surgery and anesthesia. These patients typically present with incomplete GERD control, despite optimal antisecretory drug therapy, or intolerance to medical therapy. Stretta should be considered only for patients who fit the anatomic inclusion criteria, whereas antireflux surgery should be reserved for those who do not. The decision to undergo antireflux surgery or Stretta must be based on the relative risks and benefits of each procedure. Although antireflux surgery provides better control of esophageal acid exposure than Stretta, the outcomes for GERD symptoms, quality of life, and reduction in PPI use are comparable. Stretta has a low risk of acute adverse events, has no reported cases of long-term dysphagia, and obviates general anesthesia and hospitalization, whereas antireflux surgery has a reported adverse event rate of approximately 2%, a considerable incidence of dysphagia, and requires general anesthesia and 1 to 2 days in the hospital. Another advantage of the Stretta procedure is that antireflux surgery still can be performed in the case of failures. In conclusion, the Stretta procedure offers a minimally invasive, safe, and effective alternative to antireflux surgery for those patients who have GERD who are controlled unsatisfactorily on antisecretory medications, who are considering surgery, and who meet the anatomic criteria that make the procedure technically feasible and safe.
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Affiliation(s)
- Ronald W Yeh
- Division of Gastroenterology and Hepatology, Stanford University School of Medicine, Alway Building M-211, 300 Pasteur Drive, Stanford, CA 94305, USA
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Abstract
Gastroesophageal reflux disease (GERD) is a chronic condition affect-ing over 7% of the US population. The primary objective of therapy is symptom relief, with secondary goals to heal esophagitis, prevent reflux-related complications, and maintain remission. There are several new endoscopic therapies (ETs) for treatment of GERD, generating considerable interest. An outpatient procedure, performed without an incision and general anesthesia, is attractive to patients and these therapies are being rapidly introduced, despite lack of long-term follow-up and randomized trials. In this article, the authors review endoscopic procedures, including technical aspects, mechanisms of action, safety, efficacy, and tolerability. Patient selection and relevant human studies are reviewed to clarify advantages and disadvantages of ET compared with conventional procedures.
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Affiliation(s)
- Alberto de Hoyos
- Cardiothoracic Surgery, Northwestern Memorial Hospital, 215 East Huron 10-105, Chicago, IL 60611, USA
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Portale G, Filipi CJ, Peters JH. A current assessment of endoluminal approaches to the treatment of gastroesophageal reflux disease. Surg Innov 2005; 11:225-34. [PMID: 15756391 DOI: 10.1177/155335060401100405] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
Over the past decade, a number of endoscopic techniques have been developed as alternatives to medical and surgical treatment of gastroesophageal reflux disease (GERD). The driving force was to provide an outpatient transoral, endoscopic procedure effective in controlling reflux in a portion of patients with GERD. Three major technologies emerged, although each use different approaches to augment the barrier function of the lower esophageal sphincter, mechanisms may be similar. These include Endocinch which tightens the gastroesophageal junction via a set of suture plications around the lower esophageal sphincter, Stretta, which delivers radiofrequency energy at the cardia, and Enteryx, which is an inert polymer injected into the muscle layer of the gastroesophageal junction. To date, the underlying mechanism of action of these procedures has not been completely elucidated, although each alters the compliance of the GEJ and thus its ability to respond to a "refluxogenic stress". The target population currently consists of proton pump inhibitor-dependent GERD patients, with little or no hiatal hernia and without severe esophagitis or Barrett's. The Stretta procedure is the only procedure to date to be subjected to a sham-controlled trial. Registries of complications suggest that these techniques are relatively safe, but serious morbidity including rare mortality have been reported. All can be performed on an outpatient basis. Future comparative studies with predetermined end points, validated outcome measures, prolonged follow-up, and complete complication registries are needed to determine the role of endoscopic procedures in the clinical practice of patients with GERD. Evolution of the current technologies will almost certainly occur, and a commonly performed, efficacious endoscopic antireflux procedure is likely to emerge.
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Affiliation(s)
- Giuseppe Portale
- Division of Thoracic and Foregut Surgery, University of Southern California, Los Angeles, CA, USA
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Liu DC, Somme S, Mavrelis PG, Hurwich D, Statter MB, Teitelbaum DH, Zimmermann BT, Jackson CCA, Dye C. Stretta as the initial antireflux procedure in children. J Pediatr Surg 2005; 40:148-51; discussion 151-2. [PMID: 15868576 DOI: 10.1016/j.jpedsurg.2004.09.032] [Citation(s) in RCA: 36] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/25/2022]
Abstract
BACKGROUND The Stretta procedure is an endoluminal antireflux procedure using radio frequency to induce collagen tissue contraction, remodeling, and modulation of lower esophageal sphincter physiology in an effort to treat gastroesophageal reflux disease (GERD). Although Stretta has been widely reported in the adult GERD literature as a viable initial surgical option, similar use in children has not been reported. The authors present the first report of Stretta as the initial antireflux procedure in children with GERD, evaluating indications, safety, and efficacy. METHOD The charts of 8 children (aged 11-16 years) who received Stretta between January 2003 and September 2003 were retrospectively reviewed under an Institutional Review Board protocol. All patients had documented GERD preoperatively. Three children required concomitant feeding tube placement (percutaneous gastrostomy tube, group A). Five children with isolated severe GERD refractory to aggressive medical therapy received Stretta only (group B). RESULTS Stretta was successfully completed in all 8 children. In group A, 1 child developed a postoperative aspiration, which was successfully treated. All 3 children had resolution of their GERD symptoms (ie, feeding intolerance, emesis) and were able to tolerate full enteral nutrition post-Stretta. In group B, 3 of 5 children are currently off medications and asymptomatic on short-term follow-up (6-15 months). Of the remaining 2, 1 experienced symptomatic relief immediately postprocedure, but symptoms recurred off medications. Stretta was deemed unsuccessful in the remaining patient, and Nissen fundoplication was subsequently performed without difficulty. CONCLUSIONS Stretta can be safely and successfully used as the initial antireflux procedure for children with GERD. Concomitant Stretta with PEG is an attractive option in children with preexisting GERD who require long-term feeding access. Longer follow-up and a larger patient population are needed to better confirm the safety and efficacy of Stretta presented in this report.
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Affiliation(s)
- Donald C Liu
- University of Chicago Comer Children's Hospital, Chicago, IL 60637, USA.
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Rosemurgy AS, Arnaoutakis DJ, Thometz DP, Binitie O, Giarelli NB, Bloomston M, Goldin SG, Albrink MH. Reoperative Fundoplications are Effective Treatment for Dysphagia and Recurrent Gastroesophageal Reflux. Am Surg 2004. [DOI: 10.1177/000313480407001206] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
Abstract
With wide application of antireflux surgery, reoperations for failed fundoplications are increasingly seen. This study was undertaken to document outcomes after reoperative fundoplications. Sixty-four patients, 26 men and 38 women, of average age 55 years ± 15.6 (SD), underwent reoperative antireflux surgery between 1992 and 2003. Fundoplication prior to reoperation had been undertaken via celiotomy in 27 and laparoscopically in 37. Both before and after reoperative antireflux surgery, patients scored their reflux and dysphagia on a Likert Scale (0 = none, 10 = continuous). Reoperation was undertaken because of dysphagia in 16 per cent, recurrent reflux in 52 per cent (median DeMeester Score 52), or both in 27 per cent. Failure leading to reoperation was due to hiatal failure in 28 per cent, wrap failure in 19 per cent, both in 33 per cent, and slipped Nissen fundoplication in 20 per cent. Laparoscopic reoperations were completed in 49 of 54 patients (91%); 15 had reoperations undertaken via celiotomy. Eighty-eight per cent of reoperations were Nissen fundoplications. With reoperation, Dysphagia Scores improved from 9.5 ± 0.7 to 2.6 ± 2.8, and Reflux Scores improved from 9.1 ± 1.4 to 1.8 ± 2.7. Seventy-nine per cent of patients with reflux prior to reoperation, 100 per cent with dysphagia, and 74 per cent with both noted excellent or good outcomes after reoperation. We conclude that failure after fundoplication occurs. Reoperations reduce the severity of dysphagia and reflux, thus salvaging excellent and good outcomes in most. Laparoscopic reoperations are generally possible. Reoperative fundoplications are effective treatment for dysphagia and recurrent gastroesophageal reflux, and their application is encouraged.
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Affiliation(s)
| | | | - Donald P. Thometz
- From the Department of Surgery, University of South Florida, Tampa, Florida
| | - Odion Binitie
- From the Department of Surgery, University of South Florida, Tampa, Florida
| | | | - Mark Bloomston
- From the Department of Surgery, University of South Florida, Tampa, Florida
| | - Steve G. Goldin
- From the Department of Surgery, University of South Florida, Tampa, Florida
| | - Michael H. Albrink
- From the Department of Surgery, University of South Florida, Tampa, Florida
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Richards WO. Gastroesophageal reflux disease and the truth about endoluminal therapy. J Gastrointest Surg 2004; 8:930-1. [PMID: 15702524 DOI: 10.1016/j.gassur.2004.09.052] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/31/2023]
Affiliation(s)
- William O Richards
- Department of Surgery, Vanderbilt University School of Medicine, Nashville, TN 37232-5732, USA.
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Metz DC. Managing gastroesophageal reflux disease for the lifetime of the patient: evaluating the long-term options. Am J Med 2004; 117 Suppl 5A:49S-55S. [PMID: 15478853 DOI: 10.1016/j.amjmed.2004.07.009] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
Abstract
Lifetime management goals of gastroesophageal reflux disease (GERD) are to control esophageal as well as extraesophageal symptoms, maintain a stable noninflamed esophageal mucosa, and prevent complications. Large randomized clinical trials and >16 years of worldwide experience have confirmed the high rate of efficacy and excellent safety profile of proton pump inhibitor (PPI) therapy in individuals with all grades of GERD, making these agents the mainstay of treatment. Despite these outcomes, some individuals may desire an alternative to pharmacologic therapy. In such patients, laparoscopic fundoplication may produce symptom relief and healing of esophagitis, but its invasiveness, cost, and inherent surgical risks have created an interest in a variety of endoscopic therapies for reflux disease. Several short-term uncontrolled trials of these endoscopic therapies have reported encouraging preliminary results; however, careful patient selection as well as clinician experience is critical for their success. In addition to clinician expertise with the procedure, success has been observed only in patients with nonerosive GERD and a hiatal hernia <3 cm, abnormal pH monitoring, and normal esophageal motility studies, as well as in those who have experienced at least partial symptom relief with PPI therapy. Endoscopic therapy should not be considered the standard of care in patients with erosive disease or large hiatal hernias.
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Affiliation(s)
- David C Metz
- Department of Gastroenterology, Hospital of University of Pennsylvania, Philadelphia, Pennsylvania 19104-4283, USA
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DiBaise JK, Oleynikov D. Endoluminal treatment of GERD--role in contemporary clinical practice. MEDGENMED : MEDSCAPE GENERAL MEDICINE 2004; 6:15. [PMID: 15520638 PMCID: PMC1435635] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Subscribe] [Scholar Register] [Indexed: 05/01/2023]
Affiliation(s)
- John K DiBaise
- Department of Internal Medicine, Section of Gastroenterology and Hepatology, University of Nebraska Medical Center, Omaha, Nebraska, USA
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Laparoscopic Fundoplication: 5-Year Follow-up. Am Surg 2004. [DOI: 10.1177/000313480407000807] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
Abstract
There are few published reports on outcomes of 5 or more years following laparoscopic fundoplication. Gastroesophageal reflux disease (GERD) specific quality of life questionnaires (QOLRAD), short form health surveys (SF12), and queries regarding current medication use and long-term satisfaction were mailed to all patients who underwent laparoscopic fundoplication at our institution. Results are reported as mean ± SEM. Seventy-six patients underwent laparoscopic fundoplication (63 Nissen, 13 Toupet) between November 1992 and December 1997. Fifty-two patients completed questionnaires (68%). Mean follow-up was 5.1 ± 0.2 years (range, 4–9 years). Mean QOLRAD scores were 5.8 ± 0.2, (scale 0–7, a higher score reflecting improved QOL), which is comparable to the general population (6.0 mean). SF-12 mental and physical scores were 46.6 ± 1.7 and 34.2 ± 1.6, respectively, versus 50.7 and 51.2 for the general population. Forty-seven patients (92%) would have the procedure again. Eleven (21%) remained on antisecretory medications (15% proton pump inhibitor and 6% H2 receptor antagonists). None of the 11 patients underwent 24-hour pH testing to document persistent acid exposure. Furthermore, postoperative symptoms of heartburn, dysphagia, and abdominal bloating were rated as none to mild in the majority of patients. Laparoscopic fundoplication is an effective long-term treatment for GERD, resulting in high patient satisfaction, improved quality of life, and elimination of antisecretory medicines in the majority of patients.
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Torquati A, Houston HL, Kaiser J, Holzman MD, Richards WO. Long-term follow-up study of the Stretta procedure for the treatment of gastroesophageal reflux disease. Surg Endosc 2004; 18:1475-9. [PMID: 15791372 DOI: 10.1007/s00464-003-9181-y] [Citation(s) in RCA: 48] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/03/2003] [Accepted: 03/04/2004] [Indexed: 12/15/2022]
Abstract
BACKGROUND The endoscopic delivery of temperature-controlled radiofrequency energy to the gastroesophageal junction (Stretta procedure) recently has been shown effective for patients with gastroesophageal reflux disease (GERD). However, its effectiveness has been assessed mainly over short periods (6-12 months). This study aimed to evaluate long-term results of the Stretta procedure. METHODS All patients undergoing the Stretta procedure since August 2000 were prospectively evaluated under an institutional review board-approved protocol. All patients with a follow-up period longer than 18 months were recruited for a 24-h pH study and mailed a follow-up survey, which included the following: Short Form 12 (SF-12) health status questionnaire, GERD-specific quality-of-life questionnaire (QOLRAD), and queries regarding long-term satisfaction and medication use. RESULTS The Stretta procedure was performed on 82 patients, and 41 patients with a follow-up period longer than 18 months qualified for the study. Follow-up surveys were completed by 36 patients (88%) during a mean follow-up period of 27.1 +/- 3.7 months. Of these 36 patients, 30 (83%) were highly satisfied with the procedure and would have it performed again. More than half of the Fifty Stretta patients (56%) had completely discontinued their use of proton pump inhibitors (PPIs), and an additional 31% had reduced their dose significantly. The mean PPI equivalent doses were 37.8 +/- 22.2 mg/day before the Stretta procedure and 11.6 +/- 14.6 mg/day at 27-month follow-up assessment (p = 0.001). According to the patient outcomes for daily PPI use (yes/no), the patients were divided into two groups: responders (n = 20) and nonresponders (n = 16). The responder group scored higher in QOLRAD score (p = 0.0001), SF-12 physical score (p = 0.038), and SF-12 mental score (p = 0.003). In the 24-hour pH study, the responder group demonstrated a significant decrease in distal esophageal acid exposure time (6.4% +/- 1.5% to 3.1% +/- 1.4%; p = 0.0001). CONCLUSION The Stretta procedure results in a statistical significant long-term decrease in GERD symptoms and PPI use. The treatment effect is durable beyond 2 years, and 56% of patients had discontinued their user of all antisecretory drugs.
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Affiliation(s)
- A Torquati
- Department of Surgery, Vanderbilt University Medical Center, D-5219 MCN, Nashville, TN 37232, USA
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Lutfi RE, Torquati A, Richards WO. Endoscopic treatment modalities for gastroesophageal reflux disease. Surg Endosc 2004; 18:1299-315. [PMID: 15803228 DOI: 10.1007/s00464-003-8292-9] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/16/2003] [Accepted: 03/04/2004] [Indexed: 02/08/2023]
Abstract
A debate has been going for decades between surgeons and gastroenterologists about the treatment of choice for gastroesophageal reflux disease (GERD). The lower esophageal sphincter (LES) has been historically far from the reach of gastroenterologists, who adopted the symptomatic treatment as their approach to reflux disease through reduction of gastric acid. As for surgeons, reaching the LES was only possible by invading the thoracic or abdominal cavity. Although their approach was later refined to become "minimally" invasive, it was still deemed too invasive by others to allow it to be the "gold standard." Simple logic should lead one to think about the "natural route" as the easiest way to reach the LES. This concept has opened the door for the new era of GERD treatment through "endoscopic modality." Seven different techniques are currently being used to treat patients with GERD. We review the mechanism of action, potential side effects, efficacy, durability, and results from the most recent or largest experience of each. This review shows that endoscopic treatment has definitely earned its place as a viable option for GERD treatment in selected patients. With the available data from clinical trials, it is not possible to determine the best modality available, and the endoscopic treatment of choice is to be determined with further studies.
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Affiliation(s)
- R E Lutfi
- Department of Surgery, Vanderbilt University School of Medicine, D 5203 MCN, Nashville, TN 37232-2577, USA
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Triadafilopoulos G. Changes in GERD symptom scores correlate with improvement in esophageal acid exposure after the Stretta procedure. Surg Endosc 2004; 18:1038-44. [PMID: 15156392 DOI: 10.1007/s00464-003-8243-5] [Citation(s) in RCA: 33] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/22/2004] [Accepted: 02/15/2004] [Indexed: 10/26/2022]
Abstract
BACKGROUND Endoscopic radiofrequency energy delivery (Stretta) is effective for managing gastroesophageal reflux disease (GERD) in selected patients. One criticism, however, is a theory that a mechanism of action is partial desensitization of the esophageal body rather than a reduction in esophageal acid exposure. To resolve this question, this study sought to determine if there is a correlation between the improvement in GERD outcomes and esophageal acid exposure after Stretta. METHODS Subgroup analyses were performed between "responder" and "nonresponder" groups from the U.S. Stretta open label trial ( n = 118), on the basis of posttreatment responses for GERD health-related quality of life (HRQL) heartburn, satisfaction, and proton pump inhibitor use. Outcomes were analyzed within and between subgroups. Pearson correlation coefficient analysis was performed comparing distal esophageal acid exposure with each of the continuous outcomes (GERD-HRQL, heartburn, satisfaction). RESULTS Responder subgroups had significant improvements in esophageal acid exposure, whereas nonresponders had no change or less improvement in the same. Changes in GERD-HRQL and heartburn severity were correlated with changes in acid exposure ( r = 0.16, p = 0.12 and r = 0.26, p = 0.01, respectively). Changes in satisfaction were negatively correlated with changes in esophageal acid exposure ( r = 0.23, p = 0.02) because satisfaction, as expected, increased as acid exposure decreased. CONCLUSIONS Responders had significant improvement in esophageal acid exposure, whereas nonresponders had less or no change. There was a positive correlation between esophageal acid exposure and both GERD-HRQL and heartburn. This evidence suggests that symptomatic improvement after Stretta is attributable to a decrease in esophageal acid exposure and not to desensitization of the esophagus.
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Affiliation(s)
- G Triadafilopoulos
- Gastroenterology Section, Veterans Affairs Palo Alto Health Care System, and the Division of Gastroenterology and Hepatology, Stanford University School of Medicine, 3801 Miranda Avenue, Palo Alto, Stanford CA 94304, USA.
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Freston JW, Triadafilopoulos G. Review article: approaches to the long-term management of adults with GERD-proton pump inhibitor therapy, laparoscopic fundoplication or endoscopic therapy? Aliment Pharmacol Ther 2004; 19 Suppl 1:35-42. [PMID: 14725577 DOI: 10.1111/j.0953-0673.2004.01837.x] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
The goals of gastro-oesophageal reflux disease (GERD) treatment are to control symptoms, heal the injured oesophageal mucosa, and prevent complications. Pharmacological therapy is effective in producing acute symptom relief and mucosal healing, as well as the long-term maintenance of remission. Proton pump inhibitors are the mainstay of GERD therapy. However, the need for daily administration, failure to provide complete symptom relief and costs of these agents may limit their use in some patients, prompting a consideration of alternative treatment strategies. Laparoscopic fundoplication may achieve symptom relief and healing of the oesophagitis in these individuals, but its invasiveness, cost and inherent surgical risks have created an interest in endoscopic therapies for GERD, with several emerging during the past few years. These interventions may either be viewed as an alternative therapy or as 'bridge' therapy, with patients still choosing to be treated with acid anti-secretory drugs or fundoplication if the endoscopic procedure fails to provide adequate symptom relief or if symptoms recur. Patient selection is critical for the success of fundoplication as well as endoscopic procedures, with ideal candidates being those with well-established endoscopically documented GERD, abnormal pH monitoring, normal oesophageal motility studies, and who have experienced at least partial symptom relief with proton pump inhibitor therapy. Hiatal hernia is not a contra-indication to fundoplication, while endoscopic intervention is best suited for those with a hiatal hernia of less than 3 cm in length. The long-term efficacy, cost-effectiveness, and impact of endoscopic procedures on extra-oesophageal manifestations of GERD and risk for GERD-related complications has not been determined.
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Affiliation(s)
- J W Freston
- University of Connecticut Health Center, Farmington Avenue, Farmington, CT 06030-1111, USA.
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Abstract
The Stretta procedure is increasingly offered as first-line therapy before more invasive surgical procedures for selected patients with gastroesophageal reflux disease (GERD). Although a new addition to the clinical armamentarium, thus far the Stretta procedure appears to be a safe and effective technology for the treatment of GERD, with well-documented clinical trial data supporting its efficacy, safety, and patient satisfaction.
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