Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction

Mayo Clinic

Status: Enrolling

Conditions: Bariatric Surgery Complication; Sleeve Gastrectomy; Gastroesophageal Reflux

Treatments: Device: EndoFLIP measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT04411823

19-000348

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Intervention arm

Experimental group

Description:

Undergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy

Treatment:

Device: EndoFLIP measurement