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NCT Number: NCT05066594

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

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.

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Key information

Conditions

Gastro Esophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS San Raffaele

Milan, 20132, Italy

Location status: Recruiting

Location contact

Emanuela Ribichini, MD, PhD

SUB_INVESTIGATOR

Pier Alberto Testoni, MD, Prof.

CONTACT

[email protected]

+39 02/26432756

Pier Alberto Testoni, MD, Prof.

PRINCIPAL_INVESTIGATOR

Sabrina Gloria Giulia Testoni, MD, PhD

CONTACT

[email protected]

+39 02/26436303

Sabrina Gloria Giulia Testoni, MD, PhD

SUB_INVESTIGATOR

Sandro Passaretti, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transoral incisionless fundoplication

Device

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.

Primary outcomes

  1. Medical use and dosage

    Time frame: 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 outcomes

  1. Health Related Quality of Life questionnaire score

    Time frame: 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

  2. Reflux Symptom Index questionnaire score

    Time frame: 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

  3. Esophagitis

    Time frame: 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

  4. Hill's grade of the gastro-esophageal flap valve

    Time frame: 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

  5. Jobe's length of the gastro-esophageal valve

    Time frame: 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

  6. Barrett's esophagus

    Time frame: 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

  7. High-resolution esophageal manometry findings

    Time frame: 12 months after the date of the intervention

    Esophageal manometry measurements after the intervention

  8. 24-hour esophageal pH-metry findings

    Time frame: 12 months and 24 months after the date of the intervention

    24-hour esophageal pH-metry measurements off proton pump inhibitors after the intervention

  9. 24-hour esophageal impedancemetry findings

    Time frame: 12 months and 24 months after the date of the intervention

    24-hour esophageal pH-impedance measurements off proton pump inhibitors after the intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Pier Alberto Testoni, MD, Prof.

CONTACT

[email protected]

+39 02/26432756

Sabrina Gloria Giulia Testoni, MD, PhD

CONTACT

[email protected]

+39 02/26436303

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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

Acronym: TIF/2021

Important dates

Study start
2021
Primary completion
2026
Study completion
2029
First posted
Oct 4, 2021
Registry last updated
Oct 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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