Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)

Официальное название

Observational Registry of Transoral Incisionless Fundoplication (Creation of a New Gastroesophageal Valve) in Patients With Gastroesophageal Reflux Disease

Обзор

This observational registry aims to: 1) record the TIF interventions in patients with esophageal or extra-esophageal symptoms; 2) to monitor the therapy response through the clinical experience in terms of effect on the use and dosage of proton pump inhibitors (PPIs) and on the GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaires scores; 3) to characterize the treated patients population and the predictive factors of TIF success, identifying the subpopulation who may effectively benefit from TIF.

Подробное описание

After being evaluated according to the clinical indication for the treatment of symptomatic gastro-esophageal reflux disease (GERD with esophageal or extraesophageal symptoms) by transoral incisionless fundoplication (TIF) and, thus, being treated by TIF using the EsophyX device, all patients giving specific informed consent will enter a 3-year enrollment registry with a 5-year follow-up for each patient through post-TIF routine practice visits and examinations.

Вмешательства

• Устройство Transoral incisionless fundoplication
  The intervention of transoral incisionless fundoplication using the EsophyX (EndoGastric Solutions) system allows, through the endoscopic route, the creation of a cardial neovalve of approximately 270 ° by placing 20-28 polyethylene sutures on the cardial circumference, resulting in an anti-reflux plastic functionally similar to that obtained with the surgical fundoplication.

Первичные конечные точки

• Medical use and dosage [Срок оценки: Yearly, up to 5 years from the date of the intervention]

Вторичные конечные точки (9)

• Health Related Quality of Life questionnaire score [Срок оценки: Yearly, up to 5 years from the date of the intervention]
• Reflux Symptom Index questionnaire score [Срок оценки: Yearly, up to 5 years from the date of the intervention]
• Esophagitis [Срок оценки: 6 months and 12 months after the date of the intervention]
• Hill's grade of the gastro-esophageal flap valve [Срок оценки: 6 months and 12 months after the date of the intervention]
• Jobe's length of the gastro-esophageal valve [Срок оценки: 6 months and 12 months after the date of the intervention]
• Barrett's esophagus [Срок оценки: 6 months and 12 months after the date of the intervention]
• High-resolution esophageal manometry findings [Срок оценки: 12 months after the date of the intervention]
• 24-hour esophageal pH-metry findings [Срок оценки: 12 months and 24 months after the date of the intervention]
• 24-hour esophageal impedancemetry findings [Срок оценки: 12 months and 24 months after the date of the intervention]

Критерии участия

Inclusion Criteria for enrollment:

• Clinical indication to undergo transoral incisionless fundoplication (TIF) with the EsophyX device for treatment of chronic gastro-esophageal reflux disease;
• Availability for prolonged follow-up (5 years) after TIF at San Raffaele Hospital;
• Signed informed consent for participation in the observational registry.

Exclusion Criteria for enrollment:

• Absence of clinical indication to undergo transoral incisionless fundoplication (TIF) with the EsophyX device for treatment of chronic gastro-esophageal reflux disease;
• Unavailability for prolonged follow-up (5 years) after TIF at San Raffaele Hospital;
• No signed informed consent for participation in the observational registry.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Италия · 1 центр

• IRCCS San Raffaele — Milan

Идентификаторы

NCT: NCT05066594 · TIF REGISTRY 2021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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