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Enrolling by Invitation

NCT Number: NCT04457193

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

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.

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Key information

Conditions

Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions Transoral Incisionless Fundoplication

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Saowanee Ngamruengphong

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TIF

Device

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 outcomes

  1. Percentage of participants with normal esophageal acid exposure time

    Time frame: 6 months

    Normal esophageal acid exposure time is 6 percent or less.

Secondary outcomes

  1. Percentage of participants that are able to discontinue PPI post TIF

    Time frame: 6 months

    Percentage of participants that are able to discontinue PPI post TIF will be assessed at 6 months.

  2. Incidence of esophagitis post-TIF

    Time frame: 6 months

    The presence of esophagitis on upper endoscopy.

  3. Proportion of patients with recurrence of BE and BE-related dysplasia

    Time frame: Up to 36 months

    Proportion of patients with recurrence of BE and BE-related dysplasia will be assessed up to 36 months.

  4. Number of TIF-related serious adverse events

    Time frame: Up to 36 months

    Treatment related serious adverse events (SAEs) including hospitalization, unscheduled emergency room or physician visits for post-TIF symptoms), bloating, dysphagia.

  5. 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

    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.

  6. Change in Gastroesophageal Reflux Disease (GERD) symptoms assessed by the Reflux Symptom Index (RSI)

    Time frame: Baseline, 6, 12, 24 and 36 months

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2020
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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