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Predicting Reflux After Sleeve Gastrectomy

This study aims to predict who will develop new or worsening gastroesophageal reflux disease (GERD) after sleeve gastrectomy (a weight-loss surgery). Researchers will use a device called EndoFLIP, which measures how stretchy your esophagus is during an endoscopy (a procedure where a thin tube with a camera is inserted down your throat). You could join if you are an adult over 18, have a BMI of 30 or higher, and are planning to have sleeve gastrectomy. The study will look at whether the EndoFLIP measurements and other endoscopy findings can help predict GERD up to 5 years after surgery. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 200 participants. It is not specified if it is randomized or blinded.
What's involved
You will undergo an upper endoscopy with EndoFLIP before surgery and complete questionnaires during follow-ups for up to 5 years. A repeat endoscopy with EndoFLIP may occur at 6 months if medically necessary.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up to 5 years after surgery.

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NCT04411823

Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction

Recruiting
NAAges 18+InterventionalDiagnostic
Mayo Clinic
~200 participants
Updated 2026-03-05 on ClinicalTrials.gov
What's tested:EndoFLIP measurement

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Worsening or new-onset gastroesophageal reflux disease
Measured over Baseline, 6 months, and 5 years

Conditions

Gastroesophageal Reflux
Sleeve Gastrectomy
Bariatric Surgery Complication

Explore related trials

Gastroesophageal Reflux

Where it's being run

2 sites across 2 states
Florida1
Minnesota1

Study leadership

  • Omar Ghanem, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Elizabeth Lemke
[email protected]
5072663317
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Worsening or new-onset gastroesophageal reflux diseaseBaseline, 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.