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

Barrett Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04457193
• Other study ID #: IRB00164823
• Status: Enrolling by invitation
• Start date: June 7, 2018
• Est. completion date: June 7, 2027

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: June 7, 2027
• Est. primary completion date: June 7, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Transoral Incisionless Fundoplication

Intervention

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.

Locations

Country	Name	City	State
United States	Saowanee Ngamruengphong	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with normal esophageal acid exposure time	Normal esophageal acid exposure time is 6 percent or less.	6 months
Secondary	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
Secondary	Incidence of esophagitis post-TIF	The presence of esophagitis on upper endoscopy.	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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