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NCT Number: NCT04411823

Post-sleeve Gastrectomy Gastroesophageal Reflux Disease Prediction

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

Recruiting

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Key information

Conditions

Gastroesophageal Reflux Bariatric Surgery Complication Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Sleeve Gastrectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orlando Health, Orlando, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EndoFLIP measurement

Device

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

Primary outcomes

  1. Worsening or new-onset gastroesophageal reflux disease

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Lemke

CONTACT

[email protected]

5072663317

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Jun 2, 2020
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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