Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction
Prediction of Post-laparoscopic Sleeve Gastrectomy Gastroesophageal Reflux Disease With an Endolumenal Functional Lumen Imaging Probe (EndoFLIP)
1 other identifier
interventional
200
1 country
2
Brief Summary
Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2020
CompletedFirst Posted
Study publicly available on registry
June 2, 2020
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
March 5, 2026
March 1, 2026
7.7 years
May 27, 2020
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Intervention arm
EXPERIMENTALUndergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy
Interventions
EndoFLIP device can measure gastroesophageal junction distensibility index and esophageal contractile pattern under FDA cleared indication. It is performed during endoscopy.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (2)
Orlando Health
Orlando, Florida, 32806, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Omar Ghanem, MD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 27, 2020
First Posted
June 2, 2020
Study Start
February 1, 2021
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
October 1, 2028
Last Updated
March 5, 2026
Record last verified: 2026-03