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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Barrett Esophagus; Transoral Incisionless Fundoplication
• Intervention / Treatment: Device: TIF

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Saowanee Ngamruengphong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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 Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants with normal esophageal acid exposure time	Normal esophageal acid exposure time is 6 percent or less.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants that are able to discontinue PPI post TIF	Percentage of participants that are able to discontinue PPI post TIF will be assessed at 6 months.	6 months
Incidence of esophagitis post-TIF	The presence of esophagitis on upper endoscopy.	6 months
Proportion of patients with recurrence of BE and BE-related dysplasia	Proportion of patients with recurrence of BE and BE-related dysplasia will be assessed up to 36 months.	Up to 36 months
Number of TIF-related serious adverse events	Treatment related serious adverse events (SAEs) including hospitalization, unscheduled emergency room or physician visits for post-TIF symptoms), bloating, dysphagia.	Up to 36 months
Change in quality of life as assessed by the GERD-Health-related quality of life Questionnaire	The GERD-Health-related quality of life (HRQL) Questionnaire has an overall score range of 0 to 75. Each item is scored from 0 to 5, with a higher score indicating worse symptoms and poorer quality of life.	Baseline, 6, 12, 24 and 36 months
Change in Gastroesophageal Reflux Disease (GERD) symptoms assessed by the Reflux Symptom Index (RSI)	The RSI is a nine-item self-administered outcome questionnaire designed to document reflux symptoms and severity. Each item is scored on a scale of 0 (no problem) to 5 (severe problem), with overall score ranging between 0 and 45. Higher scores mean more severe symptoms. RSI > 13 may be indicative of significant reflux disease.	Baseline, 6, 12, 24 and 36 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Saowanee Ngamruengphong, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2018
• Primary Completion (Estimated): June 7, 2027
• Study Completion (Estimated): June 7, 2027

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: June 30, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: IRB00164823

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes