Outcomes After Transoral Incisionless Fundoplication (TIF) Following Successful Endoscopic Ablation for Barrett's Esophagus
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TIF.
- Who it may be relevant to
- Registry conditions: Barrett Esophagus, Transoral Incisionless Fundoplication. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Outcomes After Transoral Incisionless Fundoplication (TIF) Following Successful Endoscopic Ablation for Barrett's Esophagus: A Pilot Study
Overview
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.
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.
Primary outcome measures
- Percentage of participants with normal esophageal acid exposure time [Time frame: 6 months]
Secondary outcome measures (6)
- Percentage of participants that are able to discontinue PPI post TIF [Time frame: 6 months]
- Incidence of esophagitis post-TIF [Time frame: 6 months]
- Proportion of patients with recurrence of BE and BE-related dysplasia [Time frame: Up to 36 months]
- Number of TIF-related serious adverse events [Time frame: Up to 36 months]
- Change in quality of life as assessed by the GERD-Health-related quality of life Questionnaire [Time frame: Baseline, 6, 12, 24 and 36 months]
- Change in Gastroesophageal Reflux Disease (GERD) symptoms assessed by the Reflux Symptom Index (RSI) [Time frame: Baseline, 6, 12, 24 and 36 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Saowanee Ngamruengphong — Baltimore
Identifiers
NCT: NCT04457193 · IRB00164823