Back to resultsPost-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction
Primary Purpose
Gastroesophageal Reflux, Sleeve Gastrectomy, Bariatric Surgery Complication
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EndoFLIP measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastroesophageal Reflux focused on measuring Gastroesophageal Reflux, Sleeve gastrectomy
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
Sites / Locations
- Orlando Health
- Mayo Clinic in RochesterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention arm
Arm Description
Undergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04411823
Brief Title
Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction
Official Title
Prediction of Post-laparoscopic Sleeve Gastrectomy Gastroesophageal Reflux Disease With an Endolumenal Functional Lumen Imaging Probe (EndoFLIP)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux, Sleeve Gastrectomy, Bariatric Surgery Complication
Keywords
Gastroesophageal Reflux, Sleeve gastrectomy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Undergo an upper endoscopy with EndoFLIP at baseline before sleeve gastrectomy
Intervention Type
Device
Intervention Name(s)
EndoFLIP measurement
Intervention Description
EndoFLIP device can measure gastroesophageal junction distensibility index and esophageal contractile pattern under FDA cleared indication. It is performed during endoscopy.
Primary Outcome Measure Information:
Title
Worsening or new-onset gastroesophageal reflux disease
Description
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.
Time Frame
Baseline, 6 months, and 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Lemke
Phone
5072663317
Email
Lemke.Elizabeth@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barham Abu Dayyeh, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abi Stromme
Phone
507-538-8238
Email
DLRSTABUDAYYEHLAB@mayo.edu
First Name & Middle Initial & Last Name & Degree
Elizabeth Lemke
Phone
507-266-3317
Email
Lemke.elizabeth@mayo.edu
First Name & Middle Initial & Last Name & Degree
Barham Abu Dayyeh, MD, MPH
First Name & Middle Initial & Last Name & Degree
Omar Ghanem, MD
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction
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