AJYR+GV vs RYGB for GERD

NCT07768202 | Active Not Recruiting

• 1 other identifier: AJYR+GVxRYGB/GERD
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity, Morbid; Gastroesophageal Reflux (GERD)

Keywords

Bariatric Surgery; Gastroesophageal Reflux Disease; Gastroenteroanastomosis; Roux-en-Y Gastric Bypass; Sleeve Gastrectomy; Roux-en-Y Antrojejunostomy; Morbid Obesity

Outcome Measures

Primary Outcomes (1)

• Measure: Resolution or improvement of gastroesophageal reflux disease (GERD)

  Presence of postoperative GERD (yes/no), assessed by objective measures - reduction or absence of esophagitis detected by upper endoscopy, and reduction or absence of esophageal acid exposure detected by pH monitoring - and by the subjective measure of improvement or absence of patient-reported GERD symptoms assessed during clinic visits and by the QS-DRGE questionnaire.

  Before surgery and at 6, 12, 24, and 60 months postoperatively

Secondary Outcomes (5)

• Change in body weight

  At 6, 12, 24, and 60 months postoperatively

• Change in HbA1c

  At 6, 12, 24, and 60 months postoperatively

• Change in fasting plasma glucose

  At 6, 12, 24, and 60 months postoperatively

• Change in blood pressure

  At 6, 12, 24, and 60 months postoperatively

• Change in lipid profile

  At 6, 12, 24, and 60 months postoperatively

Study Arms (2)

Group A

EXPERIMENTAL

sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis, AJYR+SG

Procedure: sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis, AJYR+SG

Group B

ACTIVE COMPARATOR

Roux-en-Y gastric bypass, RYGB

Procedure: Roux-en-Y gastric bypass, RYGB

Interventions

sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis, AJYR+SG PROCEDURE

Sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis (AJYR+SG). The greater curvature of the stomach is released from 1 cm proximal to the pylorus to the angle of His, sealing the vessels of the right and left gastroepiploic arcades and the short gastric vessels. A sleeve gastrectomy is performed with an ascending, proximal gastric partition calibrated by a 32-Fr Fouchet bougie positioned along the lesser curvature, resulting in a gastric tube of approximately 150 mL. A Roux-en-Y reconstruction is then created: the jejunum is transected 150 cm distal to the ligament of Treitz with a 45-mm white cartridge, and an 80-cm Roux (alimentary) limb is constructed, preserving at least 3 meters of common intestinal channel. The distal jejunal limb is brought to the gastric antrum in an antecolic fashion. An antrojejunal anastomosis is created between the anterior antral wall of the gastric tube and the antimesenteric border of the jejunal limb, using a continuous, single full-thickness lay

Group A

Roux-en-Y gastric bypass, RYGB PROCEDURE

The angle of His is dissected, and the lesser curvature of the stomach is dissected close to the gastric wall, 5 cm distal to the cardia, entering the lesser sac. A horizontal gastric stapling is performed at this level with a 45-mm blue cartridge. A 32-Fr Fouchet bougie is introduced orally and advanced to the level of the horizontal gastric partition. Two sequential vertical staple firings are then performed with two 45-mm blue cartridges, immediately adjacent to the bougie, completing the gastric partition at the angle of His, 1 cm lateral to the cardia, creating a small gastric pouch. The jejunum is transected 150 cm distal to the ligament of Treitz with a 45-mm white cartridge, preserving at least 3 meters of common intestinal channel. The distal jejunal segment (Roux alimentary limb) is brought to the small gastric pouch in an antecolic, antegastric fashion. A hand-sewn end-to-side gastrojejunal anastomosis is created with a 3-cm diameter, in a single extramucosal layer, with 3-0

Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Victor Dib Institute: lead

Study Sites (1)

Victor Dib Institute

Manaus, Amazonas, 69020-210, Brazil

Location

MeSH Terms

Conditions

Obesity, Morbid; Gastroesophageal Reflux

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Victor RM Dib, PhD

  Victor Dib Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, PhD, Digestive system surgeon and Director of Victor Dib Institute

Model Details: This is a prospective, double-blind, randomized clinical trial with parallel groups, conducted at Instituto Victor Dib and Hospital Beneficente Portuguesa. A total of 60 patients with clinically severe obesity (BMI 35-45 kg/m²) and symptoms of gastroesophageal reflux, aged between 18 and 65 years, will be randomly allocated in a 1:1 ratio to one of two surgical groups: Group A (sleeve gastrectomy with Roux-en-Y antrojejunal anastomosis, AJYR+SG) or Group B (Roux-en-Y gastric bypass, RYGB). Randomization is performed by drawing lots immediately after induction of anesthesia, following pre-allocation of patients into two strata matched by BMI (35-40 kg/m² and \>40 kg/m²). Patients will be followed with assessments for gastroesophageal reflux disease before surgery and at 6, 12, 24, and 60 months postoperatively. The primary outcome is the presence of postoperative GERD (dichotomous, yes/no), also analyzed in subcategories (resolved, improved, worsened, de novo). Secondary outcomes include

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 17, 2026
• Study Start: November 28, 2024
• Primary Completion: August 1, 2026
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)