Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction

Not Applicable

Recruiting

• Conditions: Bariatric Surgery Complication; Gastroesophageal Reflux; Sleeve Gastrectomy
• Interventions: Device: EndoFLIP measurement

• Registration Number: NCT04411823
• Lead Sponsor: Mayo Clinic

Brief Summary

Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.

Detailed Description

Subjects will undergo an upper endoscopy with EndoFLIP before sleeve gastrectomy to measure parameters from endoscopy and EndoFLIP device to develop a prediction model for post-operative gastroesophageal reflux disease. Subjects will undergo a repeat upper endoscopy with EndoFLIP at 6 months if an upper endoscopy is clinically indicated after surgery and complete questionnaires during follow-ups up to 5 years.

Study Timeline

• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-05-29
• Study First Posted: 2020-06-02
• Study Start: 2021-02-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-18
• Primary Completion: 2028-10
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Adult patients > 18 years
• BMI 30 or greater kg/m2
• Participants can give a consent to the procedure
• Participants have no contraindications to LSG (gastric ulceration)

Exclusion Criteria

• Participants who have LA grade C or D esophagitis, Barrett mucosa or peptic stricture.
• Patients who have evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis)
• Patients with hiatal hernia > 3 cm
• Patients with previous esophageal or stomach surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	EndoFLIP measurement	Undergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy

Primary Outcome Measures

Name	Time	Method
Worsening or new-onset gastroesophageal reflux disease	Baseline, 6 months, and 5 years	Determined by the change in the GERD-Health Related Quality of Life questionnaire score with questions individually scored on a scale of 0-5, combined to determine a total score range of 0-75 where a higher score indicates worse quality of life and increased score would indicate new or worsening GERD.

Trial Locations

Locations (2)

Orlando Health; 🇺🇸 Orlando, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States