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

Gastro Esophageal Reflux Clinical Trial

— TIF/2021  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05066594
• Other study ID #: TIF REGISTRY 2021
• Status: Recruiting
• Start date: May 1, 2021
• Est. completion date: May 2029

Study information

• Verified date: September 2021
• Source: IRCCS San Raffaele
• Contact: Pier Alberto Testoni, MD, Prof.
• Phone: +39 02/26432756
• Email: testoni.pieralberto[@]hsr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 2029
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastro Esophageal Reflux
• Gastroesophageal Reflux

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	High-resolution esophageal manometry findings	Esophageal manometry measurements after the intervention	12 months after the date of the intervention
Secondary	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
Secondary	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