Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction

Study Overview
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Brief Summary
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Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.

Detailed Description
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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.

Official Title
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Prediction of Post-laparoscopic Sleeve Gastrectomy Gastroesophageal Reflux Disease With an Endolumenal Functional Lumen Imaging Probe (EndoFLIP)

Conditions
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Gastroesophageal Reflux, Sleeve Gastrectomy, Bariatric Surgery Complication

Intervention / Treatment
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* Device: EndoFLIP measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Undergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy | Device: EndoFLIP measurement<br>* EndoFLIP device can measure gastroesophageal junction distensibility index and esophageal contractile pattern under FDA cleared indication. It is performed during endoscopy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worsening or new-onset gastroesophageal reflux disease | 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. | Baseline, 6 months, and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal Reflux, Sleeve gastrectomy