Aspiration therapy for the treatment of obesity: 4-year results of a multicenter randomized controlled trial.

BackgroundThe AspireAssist is the first Food and Drug Administration-approved endoluminal device indicated for treatment of class II and III obesity.ObjectivesWe earlier reported 1-year results of the PATHWAY study. Here, we report 4-year outcomes.SettingUnited States-based, 10-center, randomized controlled trial involving 171 participants with the treatment arm receiving Aspiration Therapy (AT) plus Lifestyle Therapy and the control arm receiving Lifestyle Therapy (2:1 randomization).MethodsAT participants were permitted to continue in the study for an additional year up to a maximum of 5 years providing they maintained at least 10% total weight loss (TWL) from baseline at each year end. For AT participants who continued the study, 5 medical monitoring visits were provided at weeks 60, 68, 76, 90, and 104 and thereafter once every 13 weeks up to week 260. Exclusion criteria were a history of eating disorder or evidence of eating disorder on a validated questionnaire. Follow-up weight, quality of life, and co-morbidities were compared with the baseline levels. In addition, rates of serious adverse event, persistent fistula, withdrawal, and A-tube replacement were reported. All analyses were performed using a per-protocol analysis.ResultsOf the 82 AT participants who completed 1 year, 58 continued to this phase of the trial. Mean baseline body mass index of these 58 patients was 41.6 ± 4.5 kg/m2. At the end of first year (at the beginning of the follow-up study), these 58 patients had a body mass index of 34.1 ± 5.4 kg/m2 and had achieved an 18.3 ± 8.0% TWL. On a per protocol basis, patients experienced 14.2%, 15.3%, 16.6%, and 18.7% TWL at 1, 2, 3, and 4 years, respectively (P < .01 for all). Forty of 58 patients (69%) achieved at least 10% TWL at 4 years or at time of study withdrawal. Improvements in quality of life scores and select cardiometabolic parameters were also maintained through 4 years. There were 2 serious adverse events reported in the second through fourth years, both of which resolved with removal or replacement of the A tube. Two persistent fistulas required surgical repair, representing approximately 2% of all tube removals. There were no clinically significant metabolic or electrolytes disorders observed, nor any evidence for development of any eating disorders.ConclusionsThe results of this midterm study have shown that AT is a safe, effective, and durable weight loss alternative for people with class II and III obesity and who are willing to commit to using the therapy and adhere to adjustments in eating behavior

Endoscopic Ultrasound-Guided Pancreatobiliary Endoscopy in Surgically Altered Anatomy

Endoscopic retrograde cholangiopancreatography (ERCP) has become the mainstay of therapy for pancreatobiliary diseases. While ERCP is safe and highly effective in the general population, the procedure remains challenging or impossible in patients with surgically altered anatomy (SAA). Endoscopic ultrasound (EUS) allows transmural access to the bile or pancreatic duct (PD) prior to ductal drainage using ERCP-based techniques. Also known as endosonography-guided cholangiopancreatography (ESCP), the procedure provides multiple advantages over overtube-assisted enteroscopy ERCP or percutaneous or surgical approaches. However, the procedure should only be performed by endoscopists experienced in both EUS and ERCP and with the proper tools. In this review, various EUS-guided diagnostic and therapeutic drainage techniques in patients with SAA are examined. Detailed step-by-step procedural descriptions, technical tips, feasibility, and safety data are also discussed

Training in Bariatric and Metabolic Endoscopic Therapies

Bariatric endoscopy is an emerging subspecialty for gastroenterologists encompassing a broad array of procedures including primary endoscopic bariatric and metabolic therapies and the treatment of complications of bariatric surgery. In addition, comprehensive understanding of lifestyle intervention and pharmacotherapy are essential to successful outcomes. This review summarizes goals and steps of training for this emerging field

Endoscopic Ultrasound-Guided Pancreatobiliary Endoscopy in Surgically Altered Anatomy

Endoscopic retrograde cholangiopancreatography (ERCP) has become the mainstay of therapy for pancreatobiliary diseases. While ERCP is safe and highly effective in the general population, the procedure remains challenging or impossible in patients with surgically altered anatomy (SAA). Endoscopic ultrasound (EUS) allows transmural access to the bile or pancreatic duct (PD) prior to ductal drainage using ERCP-based techniques. Also known as endosonography-guided cholangiopancreatography (ESCP), the procedure provides multiple advantages over overtube-assisted enteroscopy ERCP or percutaneous or surgical approaches. However, the procedure should only be performed by endoscopists experienced in both EUS and ERCP and with the proper tools. In this review, various EUS-guided diagnostic and therapeutic drainage techniques in patients with SAA are examined. Detailed step-by-step procedural descriptions, technical tips, feasibility, and safety data are also discussed