Clinical trial NCT01910688: Use of Radiofrequency Ablation for RGB Salvage
Official title: Use of Endoscopically Delivered Radiofrequency Ablation for the Treatment of Ptients Who Have Undergone Roux-en-Y Gastric Bypass and Have Failed to Achieve/ Maintain Satisfactory Excess Body Weight Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: RGB Salvage, RFA
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2013-07-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study will assess the feasibility of using endoscopic radiofrequency ablation (RFA) to treat the gastric pouch and stoma with the intent to cause tissue contraction and decreased compliance after a failed Roux-en-Y gastric bypass.

Detailed description: Obesity is a leading cause of preventable death in the United States, with approximately 300,000 related deaths per year. The most commonly performed bariatric surgical interventions are Roux-en Y gastric bypass (RGB) and laparoscopic adjustable gastric band placement. Despite the overall initial success of RGB to induce significant EBWL in the majority of patients, significant weight regain occurs in about 25% of patients at 2+ years following surgery. Given the preliminary success of endoscopic, non-surgical salvage interventions for the failed (uncomplicated) RGB patient, the present study will assess the feasibility of using endoscopic radiofrequency ablation (RFA) to treat the gastric pouch and stoma with the intent to cause tissue contraction and decreased compliance. A reduction of size and compliance may, as others have reported, result in re-establish weight loss and achieve an acceptable EBWL with minimal patient morbidity.

Eligibility criteria: Inclusion Criteria:

1. History of RGB surgery at least 1 year prior to enrollment
2. Achievement of \> 40% EBWL after RGB
3. Weight regain of \> 25% of the lost weight at the time of enrollment. For example, if excess body weight was 50 kg prior to RGB, patient must have lost at least 20 kg after RGB, then regained at least 5 kg to be eligible for the present study
4. Age 18-70 inclusive
5. Subject is able to tolerate endoscopy and sedation
6. Subject agrees to participate, fully understands content of the informed consent, and signs the informed consent form (ICF)

Exclusion Criteria:

1. History of any bariatric surgery other than RGB, including lap band
2. History or presence of a gastrogastric fistula or gastric pouch / jejunal ulceration
3. Gastrojejunostomy \> 4 cm in diameter (size estimated at time of endoscopy)
4. Perceived inability of the patient by the Investigator to comply with a post-treatment diet or medication regimen
5. History of alcohol, tobacco and/or controlled substance dependency that would impair the patient from complying with protocol requirements
6. Pregnancy
7. Subject is unable to provide informed consent for this study

Primary outcomes:
measure: Excess Body Weight Loss After RFA Treatment
timeFrame: 12 months
Secondary outcomes:
measure: Technical Feasibility: Percentage of Participants Who Completed RFA Treatment
timeFrame: Day 0, month 4, month 8
measure: Patient Tolerability
timeFrame: 12 months
measure: Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Columbia Univeristy
state: New York
Study officials:
affiliation: Columbia University
name: Julian Abrams, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dartmouth-Hitchcock Medical Center
name: Richard Rothstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abrams JA, Komanduri S, Shaheen NJ, Wang Z, Rothstein RI. Radiofrequency ablation for the treatment of weight regain after Roux-en-Y gastric bypass surgery. Gastrointest Endosc. 2018 Jan;87(1):275-279.e2. doi: 10.1016/j.gie.2017.06.030. Epub 2017 Jul 13.