NCT07768202Active, not recruiting
AJYR+GV vs RYGB for GERD
Sleeve Gastrectomy With Roux-en-Y Antrum-jejunal Anastomosis Versus Roux-en-Y Gastric Bypass for Gastroesophageal Reflux Disease: A Randomized Surgical Trial
Source: ClinicalTrials.gov · Last updated 17 Aug 2026
Brief summary (registry, in English)
This study focuses on gastroesophageal reflux disease (GERD), a condition in which stomach acid flows back into the esophagus (the tube that carries food from the mouth to the stomach), causing heartburn and other symptoms. GERD is common among people with obesity.The standard surgical treatment for these patients is Roux-en-Y gastric bypass, a surgery that makes the stomach smaller and reroutes part of the digestive tract. This procedure promotes weight loss and usually improves reflux. However, recent studies show that up to 20% of patients continue to have, or develop, reflux after this surgery. Untreated reflux can seriously impair quality of life and may lead to complications such as esophageal ulcers and esophageal cancer. In addition, the bypass leaves parts of the digestive tract that cannot be examined with routine endoscopy, which may make it harder to detect cancers in those areas in the future.This study will compare the standard gastric bypass with a newer procedure that combines sleeve gastrectomy (removal of most of the stomach, leaving a narrow tube) with a Roux-en-Y antrum-jejunal anastomosis (a connection between the lower part of the stomach and the small intestine). This new technique may control reflux as effectively as the bypass while keeping the whole digestive tract accessible to endoscopic examination.Adults with obesity and GERD who are candidates for bariatric surgery may participate. Participants will be randomly assigned (by chance, like a coin flip) to receive one of the two procedures. The main goals of the study are to evaluate whether the new technique treats or controls reflux as well as, or better than, the standard bypass; to compare weight loss between the two procedures; to compare changes in metabolism (how the body processes sugar and fats); to check whether the duodenum (the first part of the small intestine) can be easily examined by endoscopy after the new procedure; and to understand how food moves through the digestive tract after the new procedure.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 6 Aug 2026
- Start date
- 28 Nov 2024
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Victor Dib Institute
- Diseases
- Obesity
- NCT number
- NCT07768202
What you commit to
- Study type: Interventional
- Participants enrolled: 60
- From 28 Nov 2024 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe esophageal motor disorders
- Crohn's disease
- Advanced-stage cancer or ongoing cancer treatment
- Failure to undergo the study examinations during follow-up, or withdrawal of informed consent at any time during follow-up (patients will be excluded, and their data analyzed up to the moment of dropout)
Who the study is looking for
- Candidates for AJYR+SG or RYGB, aged \>18 and \<65 years
- BMI ≥35 and ≤45 kg/m²
- Presence of gastroesophageal reflux symptoms
- Agreement to randomization between the AJYR+SG and RYGB techniques
- Signed informed consent form (ICF)
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Victor Dib Institute Coordinator of this site? Confirm its status | Manaus | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.