Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EndoFLIP measurement.
- Who it may be relevant to
- Registry conditions: Gastroesophageal Reflux, Sleeve Gastrectomy, Bariatric Surgery Complication. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prediction of Post-laparoscopic Sleeve Gastrectomy Gastroesophageal Reflux Disease With an Endolumenal Functional Lumen Imaging Probe (EndoFLIP)
Overview
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
- Device EndoFLIP measurement
EndoFLIP device can measure gastroesophageal junction distensibility index and esophageal contractile pattern under FDA cleared indication. It is performed during endoscopy.
Primary outcome measures
- Worsening or new-onset gastroesophageal reflux disease [Time frame: Baseline, 6 months, and 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 2 centers
- Orlando Health — Orlando
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT04411823 · 19-000348