Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)

Gastroesophageal Reflux Disease Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD: the TIF vs. Sham Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110811
• Other study ID #: D2009-10
• Status: Completed
• Phase: N/A
• Start date: April 2010
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: EndoGastric Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study objective is to evaluate the relative merits, safety and effectiveness of transoral incisionless fundoplication (TIF) in proton pump inhibitor (PPI) dependent GERD patients compared with sham procedure.

Description:

Primary Effectiveness Endpoint: The proportion of patients in clinical remission after 6 months (without being classified as treatment failure).

Secondary Effectiveness: PPI consumption, esophageal acid exposure, reduction in QOLRAD and GSRS scores and healing of reflux esophagitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2018
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80 years

• On daily PPIs for > 6 months

• Documented PPI dependency

• Persistent GERD symptoms without PPI therapy during the titration phase of the study

• Evidence of two or more of the following while off PPI therapy (> 10 days):

• Erosive esophagitis (Los Angeles grade A-C)

• Abnormal ambulatory pH study

• Moderate to severe GERD symptoms

• Normal or near normal esophageal motility (by manometry)

• Patient willing to cooperate with post-operative dietary recommendations and assessment tests

• Signed informed consent

Exclusion Criteria:

• BMI > 35

• Hiatal hernia > 3 cm

• Esophagitis LA grade D

• Esophageal ulcer

• Esophageal stricture

• Barretts esophagus (Prague: C>1, M>2)

• Esophageal motility disorder

• Severe gastric paralysis

• Pregnancy or plans for pregnancy in the next 12 months

• Immunosuppression

• ASA > 2

• Portal hypertension and/or varices

• History of previous resective gastric or esophageal surgery, cervical spine fusion, Zenker's diverticulum, esophageal epiphrenic diverticulum, achalasia, scleroderma or dermatomyositis, eosinophilic esophagitis, or cirrhosis

• Active gastro-duodenal ulcer disease

• Gastric outlet obstruction or stenosis

• Severe gastroparesis or delayed gastric emptying confirmed by solid-phase gastric emptying study if patient complains of postprandial satiety during assessment

• Coagulation disorders

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Hernia, Hiatal
• Hiatal Hernia

Intervention

Procedure:
• Transoral Incisionless Fundoplication (TIF)
The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degress around the esophagus.

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven
France	University of Nantes Hospital	Nantes
Sweden	Karolinska University, Ersta Hospital	Stockholm
Sweden	Karolinska University, Huddinge Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
EndoGastric Solutions

Countries where clinical trial is conducted

Belgium,  France,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients in clinical remission	Fifty nine per cent of patients remained in clinical remission	at 6 month follow-up
Secondary	Reduction in symptoms	GSRS score improved from 14 (range 10-21) to 10 (range 6-19) with P = 0.004.	at 6 moths follow-up
Secondary	Normalized esophageal acid exposure	Sixty nine per cent of patients (69%) in TIF surgical arm normalized esophageal acid exposure.	at 6 months follow-up
Secondary	Healed reflux esophagitis	In 80% of patients healing of esophagitis was observed	at 6 months follow-up