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.
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
100
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.
IRCCS San Raffaele
Milan, Italy
RECRUITINGMedical use and dosage
Need to use proton pump inhibitors (PPI), and at what dosage, to control the gastro-esophageal reflux symptoms after intervention
Time frame: Yearly, up to 5 years from the date of the intervention
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months and 12 months after the date of the intervention
High-resolution esophageal manometry findings
Esophageal manometry measurements after the intervention
Time frame: 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
Time frame: 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
Time frame: 12 months and 24 months after the date of the intervention
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