Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT04457193

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

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2018-06-07

Completion Date

2027-06-07

Last Updated

2025-06-11

Healthy Volunteers

No

Interventions

DEVICE

TIF

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.

Locations (1)

Saowanee Ngamruengphong

Baltimore, Maryland, United States