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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Gastro Esophageal Reflux

Intervention / Treatment
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* Device: Transoral incisionless fundoplication


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transoral incisionless fundoplication with EsophyX device (EndoGastric Solutions)<br>Patients treated by transoral incisionless fundoplication (TIF) using the EsophyX device (EndoGastric Solutions) for gastro-esophageal reflux disease will be enrolled in the registry and clinically followed-up for 5 years from the date of TIF procedure. | Device: Transoral incisionless fundoplication<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical use and dosage | Need to use proton pump inhibitors (PPI), and at what dosage, to control the gastro-esophageal reflux symptoms after intervention | Yearly, up to 5 years from the date of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life questionnaire score | Modification of the scores from the gastro-esophageal reflux disease-health related quality of life (GERD-HRQL) questionnaire (off proton pump inhibitors), according to a Likert scale from 0 (absence of symptoms) to 5 (symptoms do not allow for normal daily activity), after intervention compared with baseline | Yearly, up to 5 years from the date of the intervention | 
| Reflux Symptom Index questionnaire score | Modification of the scores from the reflux symptom index (GERD-RSI) questionnaire (off proton pump inhibitors), according to a Likert scale from 0 (no problem) to 5 (severe problem) after the intervention compared with baseline | Yearly, up to 5 years from the date of the intervention | 
| Esophagitis | Presence and degree of esophagitis according to the Los Angeles classification (grade A, grade B, grade C, grade D) after the intervention | 6 months and 12 months after the date of the intervention | 
| Hill's grade of the gastro-esophageal flap valve | Degree of continence of the neo gastro-esophageal flap valve according to the Hill classification (grade I, grade II, grade III, grade IV) after the intervention | 6 months and 12 months after the date of the intervention | 
| Jobe's length of the gastro-esophageal valve | Length of the fold of the neo gastro-esophageal valve according to the criteria of Jobe et al. after the intervention | 6 months and 12 months after the date of the intervention | 
| Barrett's esophagus | Presence and degree of Barrett's esophagus according to the Prague classification (C, M) after the intervention | 6 months and 12 months after the date of the intervention | 
| High-resolution esophageal manometry findings | Esophageal manometry measurements after the intervention | 12 months after the date of the intervention | 
| 24-hour esophageal pH-metry findings | 24-hour esophageal pH-metry measurements off proton pump inhibitors after the intervention | 12 months and 24 months after the date of the intervention | 
| 24-hour esophageal impedancemetry findings | 24-hour esophageal pH-impedance measurements off proton pump inhibitors after the intervention | 12 months and 24 months after the date of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fundoplication, Endoscopy, Digestive System, Gastro Esophageal Reflux