Clinical trial NCT04457193: Outcomes After Transoral Incisionless Fundoplication (TIF) Following Successful Endoscopic Ablation for Barrett's Esophagus
Official title: Outcomes After Transoral Incisionless Fundoplication (TIF) Following Successful Endoscopic Ablation for Barrett's Esophagus: A Pilot Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Barrett Esophagus
Transoral Incisionless Fundoplication
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with history Barrett's esophagus who have resolution of Barrett's mucosa after endoscopic ablation.

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.


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

Primary outcomes:
measure: Percentage of participants with normal esophageal acid exposure time
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of participants that are able to discontinue PPI post TIF
timeFrame: 6 months
measure: Incidence of esophagitis post-TIF
timeFrame: 6 months
measure: Proportion of patients with recurrence of BE and BE-related dysplasia
timeFrame: Up to 36 months
measure: Number of TIF-related serious adverse events
timeFrame: Up to 36 months
measure: Change in quality of life as assessed by the GERD-Health-related quality of life Questionnaire
timeFrame: Baseline, 6, 12, 24 and 36 months
measure: Change in Gastroesophageal Reflux Disease (GERD) symptoms assessed by the Reflux Symptom Index (RSI)
timeFrame: Baseline, 6, 12, 24 and 36 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Saowanee Ngamruengphong
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Saowanee Ngamruengphong
role: PRINCIPAL_INVESTIGATOR
References: