Prospective Feasibility Study of Gastrojejunostomy Anastomotic Size Reduction by Endoluminal Gastroplication in Patients with Post-Gastric Bypass Recidivism

Abstract

Background: Morbid obesity affects 10% of all obese patients (approximately 6.7 million) in the United States. The Roux-en-Y gastric bypass (RNYGB) procedure has proven long-term effects on weight loss in the morbidly obese. Surgical success is defined as 50% excess weight loss. Approximately 15% do not achieve surgical success and only 10% undergoing RNYGB reach ideal body weight. Failure to reach targeted weight loss or weight regain, also known as recidivism, is seen in a significant number of these patients. A dilated gastrojejunal (GJ) anastomosis is considered to be one of the mechanisms behind post-RNYGB recidivism. Surgical revision of the GJ anastomosis is considered challenging and is infrequently performed. A less invasive, nonsurgical approach to remedy the dilated GJ anastomosis could be a viable alternative. Aim: The primary objective of this study was to investigate the safety and feasibility of utilizing endoluminal suturing to reduce the GJ anastomotic diameter size in patients with RNYGB recidivism. The secondary endpoint was to assess weight loss following endoluminal suturing of the GJ anastomosis. Method: Following institutional IRB approval, a 3-month, prospective, single center, study of 11 RNYGB patients with weight related recidivism was conducted. Patients with GJ diameters, measured by endoscopy, of greater than 15 mm underwent endoluminal gastroplication (ENDOCINCH, Davol-CR Bard) of the GJ anastomosis. Monthly weights (1, 2, & 3 months) and dietary logs were obtained. Nutritional consultations were performed. GJ diameters were endoscopically assessed at 3 months. Results: The average total procedure time was 30 minutes with patients under deep sedation. At 3-month follow-up, the GJ anastomotic size was reduced by an average of 35% or 9 mm (P < 0.008). The average weight loss recorded per patient was 10 pounds (P < 0.0026). No post-operative complications related to the device or the procedure occurred. Conclusion: This study confirms that endoluminal suturing of the GJ anastomosis is safe and feasible. In conjunction with nutritional counseling, this data suggests that endoluminal suturing of the GJ anastomosis may be effective in decreasing weight in patients with post Roux-en-Y gastric bypass recidivism. Longer-term, multicenter studies are needed to better understand the role of endoluminal suturing for the reduction of the GJ anastomosis in this bariatric patient population. Background: Morbid obesity affects 10% of all obese patients (approximately 6.7 million) in the United States. The Roux-en-Y gastric bypass (RNYGB) procedure has proven long-term effects on weight loss in the morbidly obese. Surgical success is defined as 50% excess weight loss. Approximately 15% do not achieve surgical success and only 10% undergoing RNYGB reach ideal body weight. Failure to reach targeted weight loss or weight regain, also known as recidivism, is seen in a significant number of these patients. A dilated gastrojejunal (GJ) anastomosis is considered to be one of the mechanisms behind post-RNYGB recidivism. Surgical revision of the GJ anastomosis is considered challenging and is infrequently performed. A less invasive, nonsurgical approach to remedy the dilated GJ anastomosis could be a viable alternative. Aim: The primary objective of this study was to investigate the safety and feasibility of utilizing endoluminal suturing to reduce the GJ anastomotic diameter size in patients with RNYGB recidivism. The secondary endpoint was to assess weight loss following endoluminal suturing of the GJ anastomosis. Method: Following institutional IRB approval, a 3-month, prospective, single center, study of 11 RNYGB patients with weight related recidivism was conducted. Patients with GJ diameters, measured by endoscopy, of greater than 15 mm underwent endoluminal gastroplication (ENDOCINCH, Davol-CR Bard) of the GJ anastomosis. Monthly weights (1, 2, & 3 months) and dietary logs were obtained. Nutritional consultations were performed. GJ diameters were endoscopically assessed at 3 months. Results: The average total procedure time was 30 minutes with patients under deep sedation. At 3-month follow-up, the GJ anastomotic size was reduced by an average of 35% or 9 mm (P < 0.008). The average weight loss recorded per patient was 10 pounds (P < 0.0026). No post-operative complications related to the device or the procedure occurred. Conclusion: This study confirms that endoluminal suturing of the GJ anastomosis is safe and feasible. In conjunction with nutritional counseling, this data suggests that endoluminal suturing of the GJ anastomosis may be effective in decreasing weight in patients with post Roux-en-Y gastric bypass recidivism. Longer-term, multicenter studies are needed to better understand the role of endoluminal suturing for the reduction of the GJ anastomosis in this bariatric patient population.