NCT04457193

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

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Barrett Esophagus
• Transoral Incisionless Fundoplication

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-06-07
• Primary completion: 2027-06-07
• Completion: 2027-06-07
• First posted: 2020-07-07
• Last updated: 2025-06-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study