Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD) (TIF/2021)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastro Esophageal Reflux
• Intervention / Treatment: Device: Transoral incisionless fundoplication

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Pier Alberto Testoni, MD, Prof.; Phone Number: +39 02/26432756; Email: testoni.pieralberto@hsr.it
• Study Contact Backup: Name: Sabrina Gloria Giulia Testoni, MD, PhD; Phone Number: +39 02/26436303; Email: testoni.sabrinagloriagiulia@hsr.it

Study Locations

• Italy
  • Milan, Italy, 20132
    • Recruiting
    • IRCCS San Raffaele
    • Contact: Pier Alberto Testoni, MD, Prof.; Phone Number: +39 02/26432756; Email: testoni.pieralberto@hsr.it
    • Contact: Sabrina Gloria Giulia Testoni, MD, PhD; Phone Number: +39 02/26436303; Email: testoni.sabrinagloriagiulia@hsr.it
    • Principal Investigator: Pier Alberto Testoni, MD, Prof.
    • Sub-Investigator: Sabrina Gloria Giulia Testoni, MD, PhD
    • Sub-Investigator: Sandro Passaretti, MD
    • Sub-Investigator: Emanuela Ribichini, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inclusion criteria for TIF: >12 months esophageal or extraesophageal symptoms from gastroesophageal reflux, despite >6 months therapy with PPI; cardial valve Hill's degree >III; pathological gastroesophageal reflux; hiatal hernia ≤2 cm.

Exclusion criteria for TIF: hiatal hernia >2 cm; paraesophageal hernia; severe esophageal motility disorder or Los Angeles grade C and D esophagitis; esophageal stenosis, diverticula, infections; pregnancy, breastfeeding; bleeding disorders; malignant neoplasm; immunosuppressant therapy; portal hypertension; esophageal varices; eosinophilic esophagitis; autoimmune esophagitis; BMI ≥35; limited mobility of the neck; patients for whom the use of the EsophyX device is contraindicated.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Transoral incisionless fundoplication with EsophyX device (EndoGastric Solutions); 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele
• Investigators: Principal Investigator: Pier Alberto Testoni, Prof., IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2021
• Primary Completion (ANTICIPATED): May 1, 2026
• Study Completion (ANTICIPATED): May 1, 2029

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (ACTUAL): October 4, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 24, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Fundoplication; Endoscopy, Digestive System; Gastro Esophageal Reflux
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: TIF REGISTRY 2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes