Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04411823

Enrollment

200

Registered

2020-06-02

Start date

2021-02-01

Completion date

2028-10-01

Last updated

2026-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery Complication, Gastroesophageal Reflux, Sleeve Gastrectomy

Keywords

Gastroesophageal Reflux, Sleeve gastrectomy

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.

Interventions

DEVICEEndoFLIP measurement

EndoFLIP device can measure gastroesophageal junction distensibility index and esophageal contractile pattern under FDA cleared indication. It is performed during endoscopy.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTElizabeth Lemke

Lemke.Elizabeth@mayo.edu5072663317

PRINCIPAL_INVESTIGATOROmar Ghanem, MD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026