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 Type
OBSERVATIONAL
Enrollment
50
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.
Saowanee Ngamruengphong
Baltimore, Maryland, United States
Percentage of participants with normal esophageal acid exposure time
Normal esophageal acid exposure time is 6 percent or less.
Time frame: 6 months
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.
Time frame: 6 months
Incidence of esophagitis post-TIF
The presence of esophagitis on upper endoscopy.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6, 12, 24 and 36 months
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