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

NCT04457193 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: IRB00164823
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 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

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with normal esophageal acid exposure time

  Normal esophageal acid exposure time is 6 percent or less.

  6 months

Secondary Outcomes (6)

• Percentage of participants that are able to discontinue PPI post TIF

  6 months

• Incidence of esophagitis post-TIF

  6 months

• Proportion of patients with recurrence of BE and BE-related dysplasia

  Up to 36 months

• Number of TIF-related serious adverse events

  Up to 36 months

• Change in quality of life as assessed by the GERD-Health-related quality of life Questionnaire

  Baseline, 6, 12, 24 and 36 months

Study Arms (1)

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

Device: TIF

Interventions

TIF DEVICE

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.

post-ablation Barrett's patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with history Barrett's esophagus who have resolution of Barrett's mucosa after endoscopic ablation.

You may qualify if:

• 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

You may not qualify if:

• Age \< 18 or \> 75 years
• Inability to provide informed consent

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Saowanee Ngamruengphong

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Saowanee Ngamruengphong

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: June 7, 2018
• Primary Completion (Estimated): June 7, 2027
• Study Completion (Estimated): June 7, 2027
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)