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

Status: Enrolling by invitation
Location: See location...
Intervention Type: Device
Study Type: Observational
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 may progress to low-grade dysplasia (LGD), to high-grade dysplasia (HGD) and esophageal adenocarcinoma (EAC). Endoscopic ablation is safe and effective for complete eradication of BE. However, recurrence is common. Cumulative incidence rate of BE recurrence is up to 30% in the third year. Thus, achieving complete eradication of IM, patients should undergo surveillance indefinitely with serial endoscopy to assess for recurrence of BE. In addition, BE patients have been committed to life-long proton pump inhibitor (PPI) therapy, but increasing concerns about adverse effects has led to alternative therapies. Studies have showed that laparoscopic Nissen fundoplication may decrease recurrence of BE after endoscopic ablation. Transoral Incisionless Fundoplication (TIF) is an endoscopic procedure that mechanically creates fundoplication similar to traditional operative Nissen fundoplication. The role of TIF in patients with BE whom underwent successful endoscopic ablation has not been fully investigated.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: No
View:

• 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

Locations
United States
Maryland
Saowanee Ngamruengphong
Baltimore
Time Frame
Start Date: June 7, 2018
Estimated Completion Date: June 7, 2026
Participants
Target number of participants: 50
Treatments
post-ablation Barrett's patients
The patients with known prior diagnosis of histologically-confirmed Barrett's esophagus with or without dysplasia who have documentation of complete remission of Barrett's esophagus by endoscopy and histology after endoscopic ablation
Related Therapeutic Areas
Sponsors
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov

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