Clinical trial NCT05066594: Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)
Official title: Observational Registry of Transoral Incisionless Fundoplication (Creation of a New Gastroesophageal Valve) in Patients With Gastroesophageal Reflux Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastro Esophageal Reflux
Keywords: Fundoplication
Endoscopy, Digestive System
Gastro Esophageal Reflux
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Medical use and dosage
timeFrame: Yearly, up to 5 years from the date of the intervention
Secondary outcomes:
measure: Health Related Quality of Life questionnaire score
timeFrame: Yearly, up to 5 years from the date of the intervention
measure: Reflux Symptom Index questionnaire score
timeFrame: Yearly, up to 5 years from the date of the intervention
measure: Esophagitis
timeFrame: 6 months and 12 months after the date of the intervention
measure: Hill's grade of the gastro-esophageal flap valve
timeFrame: 6 months and 12 months after the date of the intervention
measure: Jobe's length of the gastro-esophageal valve
timeFrame: 6 months and 12 months after the date of the intervention
measure: Barrett's esophagus
timeFrame: 6 months and 12 months after the date of the intervention
measure: High-resolution esophageal manometry findings
timeFrame: 12 months after the date of the intervention
measure: 24-hour esophageal pH-metry findings
timeFrame: 12 months and 24 months after the date of the intervention
measure: 24-hour esophageal impedancemetry findings
timeFrame: 12 months and 24 months after the date of the intervention
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele
Study officials:
affiliation: IRCCS San Raffaele
name: Pier Alberto Testoni, Prof.
role: PRINCIPAL_INVESTIGATOR
References: