Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04411823
• Other study ID #: 19-000348
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: September 2024

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: Elizabeth Lemke
• Phone: 5072663317
• Email: Lemke.Elizabeth[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Researchers are trying to identify predictors for gastroesophageal reflux disease after sleeve gastrectomy.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Complication
• Esophagitis, Peptic
• Gastroesophageal Reflux
• Sleeve Gastrectomy

Intervention

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

Locations

Country	Name	City	State
United States	Orlando Health	Orlando	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Mayo Clinic Clinical Trials