A Study of Endolumenal Functional Lumen Imaging Probe (EndoFLIP) for Gastroesophageal Reflux Disease after Laparoscopic Sleeve Gastrectomy

Overview

About this study

The purpose of this study is to identify a predictive model for worsening of preexisting gastroesophageal reflux disease (GERD) or development of de novo GERD after laparoscopic sleeve gastrectomy (LSG) by using EndoFLIP, upper endoscopy and esophageal manometry to assess patients preoperatively in a discovery cohort.  This prospective predictive model will then identify sensitivity, specificity, positive and negative predictive values for prediction of worsening or de novo GERD.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adult patients > 18 years.
  • BMI over 30 kg/m2.
  • Participants can give a consent to the procedure.
  • Participants have no contraindications to LSG. (anticoagulation, gastric ulceration, hiatal hernia of > 5 cm).

Exclusion Criteria:

  • Participants who have preexisting GERD defined by GERD HRQL of more than 40.
  • If participants have GERD HRQL < 40, they will undergo upper endoscopy with Bravo esophageal pH testThey will be excluded if they meet Lyon criteria for conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6%, 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Barham Abu Dayyeh, M.D., M.P.H.

Contact us for the latest status

Contact information:

Erik Hyland B.S.

(507)284-4723

Hyland.Erik@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

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Supplemental Study Information

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