Gastro Esophageal Reflux
Conditions
Keywords
Fundoplication, Endoscopy, Digestive System, Gastro Esophageal Reflux
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.
Interventions
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.
Sponsors
IRCCS San Raffaele
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medical use and dosage | Yearly, up to 5 years from the date of the intervention | Need to use proton pump inhibitors (PPI), and at what dosage, to control the gastro-esophageal reflux symptoms after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reflux Symptom Index questionnaire score | Yearly, up to 5 years from the date of the intervention | 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 |
| Esophagitis | 6 months and 12 months after the date of the intervention | Presence and degree of esophagitis according to the Los Angeles classification (grade A, grade B, grade C, grade D) after the intervention |
| Hill's grade of the gastro-esophageal flap valve | 6 months and 12 months after the date of the intervention | 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 |
| Jobe's length of the gastro-esophageal valve | 6 months and 12 months after the date of the intervention | Length of the fold of the neo gastro-esophageal valve according to the criteria of Jobe et al. after the intervention |
| Health Related Quality of Life questionnaire score | Yearly, up to 5 years from the date of the intervention | 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 |
| High-resolution esophageal manometry findings | 12 months after the date of the intervention | Esophageal manometry measurements after the intervention |
| 24-hour esophageal pH-metry findings | 12 months and 24 months after the date of the intervention | 24-hour esophageal pH-metry measurements off proton pump inhibitors after the intervention |
| 24-hour esophageal impedancemetry findings | 12 months and 24 months after the date of the intervention | 24-hour esophageal pH-impedance measurements off proton pump inhibitors after the intervention |
| Barrett's esophagus | 6 months and 12 months after the date of the intervention | Presence and degree of Barrett's esophagus according to the Prague classification (C, M) after the intervention |
Countries
Italy
Contacts
Primary ContactPier Alberto Testoni, MD, Prof.
Backup ContactSabrina Gloria Giulia Testoni, MD, PhD
Outcome results
None listed