Набор по приглашению NCT04457193

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

— Наблюдательное Barrett Esophagus Transoral Incisionless Fundoplication

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: TIF.
Кому может быть актуально: Состояния в реестре: Barrett Esophagus, Transoral Incisionless Fundoplication. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Устройство 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.

Первичные конечные точки

Percentage of participants with normal esophageal acid exposure time [Срок оценки: 6 months]

Вторичные конечные точки (6)

Percentage of participants that are able to discontinue PPI post TIF [Срок оценки: 6 months]
Incidence of esophagitis post-TIF [Срок оценки: 6 months]
Proportion of patients with recurrence of BE and BE-related dysplasia [Срок оценки: Up to 36 months]
Number of TIF-related serious adverse events [Срок оценки: Up to 36 months]
Change in quality of life as assessed by the GERD-Health-related quality of life Questionnaire [Срок оценки: Baseline, 6, 12, 24 and 36 months]
Change in Gastroesophageal Reflux Disease (GERD) symptoms assessed by the Reflux Symptom Index (RSI) [Срок оценки: Baseline, 6, 12, 24 and 36 months]

Критерии участия

Критерии включения

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