Status:
ENROLLING_BY_INVITATION
Outcomes After Transoral Incisionless Fundoplication (TIF) Following Successful Endoscopic Ablation for Barrett's Esophagus
Lead Sponsor:
Johns Hopkins University
Conditions:
Barrett Esophagus
Transoral Incisionless Fundoplication
Eligibility:
All Genders
18-75 years
Brief Summary
Barrett's esophagus (BE) is a precancerous lesion characterized by the replacement of the normal stratified squamous epithelium of the distal esophagus by intestinal metaplasia (IM). Non-dysplastic BE...
Eligibility Criteria
Inclusion
- 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
- Age \< 18 or \> 75 years
- Inability to provide informed consent
Key Trial Info
Start Date :
June 7 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 7 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04457193
Start Date
June 7 2018
End Date
June 7 2027
Last Update
June 11 2025
Active Locations (1)
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1
Saowanee Ngamruengphong
Baltimore, Maryland, United States, 21224