Bryan J Sandler1, Laurent Biertho2, Mehran Anvari3, Roberto Rumbaut4, Luis Alonso Morales-Garza5, Gustavo Torres-Barrera4, Simon Marceau2, Dennis Hong3, C Daniel Smith6, Santiago Horgan7. 1. Division of Minimally Invasive Surgery, Department of Surgery, UC San Diego, San Diego, CA, USA. bsandler@ucsd.edu. 2. Département de Chirurgie, Université Laval, Quebec, QC, Canada. 3. Department of Surgery, McMaster University, Hamilton, ON, Canada. 4. Hospital de Tec de Monterrey, Monterrey, Nuevo León, Mexico. 5. Tecnologico de Monterrey, Escuela de Medicina y Ciencias de la Salud, Monterrey, Mexico. 6. Esophageal Institute of Atlanta, Atlanta, GA, USA. 7. Division of Minimally Invasive Surgery, Department of Surgery, UC San Diego, San Diego, CA, USA.
Abstract
BACKGROUND: Only a small percentage of candidates for bariatric surgery ever undergo a procedure for weight loss. Devices duplicating key effects of bariatric surgeries with removable, fully trans-oral implants could extend their benefits to patients unwilling to undergo anatomy-altering abdominal surgeries. METHODS:Thirty-two obese subjects (mean BMI: 42.3) were enrolled in a prospective, multicenter, single-arm, feasibility trial of the first fully trans-oral endoscopic gastrointestinal bypass device. The device is a cuff attached to the distal esophagus by transmural anchors and connected to a 120-cm sleeve diverting undigested nutrients to the jejunum. Bodyweight, vital signs, adverse events, medications, HbA1c, fasting glucose, and lipids were collected at baseline and follow-up visits. Device status was endoscopically assessed every 6 months. RESULTS: The fully trans-oral procedure was successful in all subjects without intraoperative adverse events or postoperative infections. Twenty-eight of 32 subjects (88%) remained implanted with continuing follow-up beyond their 12-month visit. At 12 months, the 32 subjects had lost an average of 44.8% of excess body weight, 17.6% of total body weight, 20.8 kg, and 7.5 BMI points. Weight loss depended on capture of ingesta by the esophageal cuff, with 18 of 32 subjects without visible gaps around their cuffs at the 6 month endoscopy having significantly greater EWL (53.6 vs. 33.4% in the remaining subjects, p < 0.002). Mean HbA1c and fasting glucose declined by 1.1% points and 29 mg/dL in type 2 diabetic subjects, 80% of whom had remission of their diabetes at 12 months. CONCLUSION: This study demonstrates the feasibility, safety, and efficacy of a fully trans-oral gastrointestinal bypass implant. This purely endoscopic device may provide a valuable addition to the armamentarium of treatment available for the management of morbid obesity.
RCT Entities:
BACKGROUND: Only a small percentage of candidates for bariatric surgery ever undergo a procedure for weight loss. Devices duplicating key effects of bariatric surgeries with removable, fully trans-oral implants could extend their benefits to patients unwilling to undergo anatomy-altering abdominal surgeries. METHODS: Thirty-two obese subjects (mean BMI: 42.3) were enrolled in a prospective, multicenter, single-arm, feasibility trial of the first fully trans-oral endoscopic gastrointestinal bypass device. The device is a cuff attached to the distal esophagus by transmural anchors and connected to a 120-cm sleeve diverting undigested nutrients to the jejunum. Bodyweight, vital signs, adverse events, medications, HbA1c, fasting glucose, and lipids were collected at baseline and follow-up visits. Device status was endoscopically assessed every 6 months. RESULTS: The fully trans-oral procedure was successful in all subjects without intraoperative adverse events or postoperative infections. Twenty-eight of 32 subjects (88%) remained implanted with continuing follow-up beyond their 12-month visit. At 12 months, the 32 subjects had lost an average of 44.8% of excess body weight, 17.6% of total body weight, 20.8 kg, and 7.5 BMI points. Weight loss depended on capture of ingesta by the esophageal cuff, with 18 of 32 subjects without visible gaps around their cuffs at the 6 month endoscopy having significantly greater EWL (53.6 vs. 33.4% in the remaining subjects, p < 0.002). Mean HbA1c and fasting glucose declined by 1.1% points and 29 mg/dL in type 2 diabetic subjects, 80% of whom had remission of their diabetes at 12 months. CONCLUSION: This study demonstrates the feasibility, safety, and efficacy of a fully trans-oral gastrointestinal bypass implant. This purely endoscopic device may provide a valuable addition to the armamentarium of treatment available for the management of morbid obesity.
Authors: Lars Sjöström; Anna-Karin Lindroos; Markku Peltonen; Jarl Torgerson; Claude Bouchard; Björn Carlsson; Sven Dahlgren; Bo Larsson; Kristina Narbro; Carl David Sjöström; Marianne Sullivan; Hans Wedel Journal: N Engl J Med Date: 2004-12-23 Impact factor: 91.245
Authors: Bryan J Sandler; Roberto Rumbaut; C Paul Swain; Gustavo Torres; Luis Morales; Lizcelly Gonzales; Sarah Schultz; Mark A Talamini; Garth R Jacobsen; Santiago Horgan Journal: Surg Endosc Date: 2015-01-29 Impact factor: 4.584
Authors: Bryan J Sandler; Roberto Rumbaut; C Paul Swain; Gustavo Torres; Luis Morales; Lizcelly Gonzales; Sarah Schultz; Mark Talamini; Santiago Horgan Journal: Surg Endosc Date: 2011-04-13 Impact factor: 4.584
Authors: Philip R Schauer; Deepak L Bhatt; John P Kirwan; Kathy Wolski; Stacy A Brethauer; Sankar D Navaneethan; Ali Aminian; Claire E Pothier; Esther S H Kim; Steven E Nissen; Sangeeta R Kashyap Journal: N Engl J Med Date: 2014-03-31 Impact factor: 91.245
Authors: Paul E O'Brien; John B Dixon; Cheryl Laurie; Stewart Skinner; Joe Proietto; John McNeil; Boyd Strauss; Sharon Marks; Linda Schachter; Leon Chapman; Margaret Anderson Journal: Ann Intern Med Date: 2006-05-02 Impact factor: 25.391
Authors: Fatima Cody Stanford; Theodore K Kyle; Mechelle D Claridy; Joseph F Nadglowski; Caroline M Apovian Journal: Obesity (Silver Spring) Date: 2014-12-28 Impact factor: 5.002
Authors: David B Sarwer; Scott Ritter; Thomas A Wadden; Jacqueline C Spitzer; Marion L Vetter; Reneé H Moore Journal: Surg Obes Relat Dis Date: 2012-10-27 Impact factor: 4.734