Outcomes After Transoral Incisionless Fundoplication (TIF) Following Successful Endoscopic Ablation for Barrett's Esophagus

Launched by JOHNS HOPKINS UNIVERSITY · Jun 30, 2020

Keywords

ClinConnect Summary

This study looks at how well a procedure called Transoral Incisionless Fundoplication (TIF) works for people with Barrett’s esophagus who have already had treatment to remove Barrett’s tissue. It's an observational, forward-looking (prospective) study at Johns Hopkins. About 50 adults aged 18 to 75 who had complete Barrett’s removal after endoscopic therapy and are on acid medicines but would like to stop them may be invited to join. To be eligible, you must have a history of Barrett’s esophagus confirmed by biopsy, proof of complete ablation on two endoscopies at least 3 months apart (most recent within 6 months), abnormal acid exposure in the esophagus, a small hiatal hernia if present, and the ability to consent.

If you join, you would undergo the TIF procedure and be followed for up to about 3 years. The main outcome after 6 months is whether the esophagus’ acid exposure becomes normal (6% or less). Other important goals include whether you can stop proton pump inhibitors by 6 months, whether there is any esophagitis seen on endoscopy at 6 months, whether Barrett’s tissue or related changes come back over 3 years, and any serious procedure-related problems. Researchers will also track your quality of life and reflux symptoms at several time points (baseline, 6, 12, 24, and 36 months). This is a pilot, non-randomized study sponsored by Johns Hopkins, currently enrolling by invitation, with completion expected in 2027. Data sharing is not planned.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 18 - 75 years
• • Known prior diagnosis of histologically-confirmed BE with or without dysplasia (as defined by the presence of specialized columnar epithelium anywhere in the tubular esophagus with \>= 1 cm of circumferential involvement or non-circumferential involvement of specialized columnar epithelium) \[Prague class \>1\] and history of initial complete eradication-IM following endoscopic ablation for Barrett's esophagus.
• • Documentation of complete ablation of BE by endoscopy and histology after radiofrequency or cryotherapy ablation on two endoscopic examinations at least 3 months apart, within most recent endoscopy performed within 6 months. Pathologic diagnosis determined by the expert pathologist at each site.
• • On PPI therapy, who opt for an intervention over lifelong drug dependence.
• • Hiatal hernia ≤ 2 cm or Hill grade \< 2 \[unless patients undergoing combined TIF and hiatal hernia repair\]
• • Abnormal esophageal acid exposure \[Percent esophageal acid exposure time \> 6% defined by Bravo ph monitoring (48 - 96 hours study)
• • Able to provide informed consent
• Exclusion Criteria:
• • Age \< 18 or \> 75 years
• • Inability to provide informed consent