Clinical trial NCT01110811: Transoral Incisionless Fundoplication (TIF) Versus Sham for Treatment of Gastroesophageal Reflux Disease (GERD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Hiatal Hernia
Keywords: GERD
Esophagitis
Fundoplication
Anti-reflux surgery
PPI dependent
Lead sponsor: EndoGastric Solutions
Sponsor class: INDUSTRY
First posted: 2010-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients in clinical remission
timeFrame: at 6 month follow-up
Secondary outcomes:
measure: Reduction in symptoms
timeFrame: at 6 moths follow-up
measure: Normalized esophageal acid exposure
timeFrame: at 6 months follow-up
measure: Healed reflux esophagitis
timeFrame: at 6 months follow-up
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
city: Nantes
country: France
facility: University of Nantes Hospital
city: Stockholm
country: Sweden
facility: Karolinska University, Ersta Hospital
city: Stockholm
country: Sweden
facility: Karolinska University, Huddinge Hospital
Study officials:
affiliation: Karolinska University, Huddinge Hospital, Stockholm, Sweden
name: Lars Lundell, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hakansson B, Montgomery M, Cadiere GB, Rajan A, Bruley des Varannes S, Lerhun M, Coron E, Tack J, Bischops R, Thorell A, Arnelo U, Lundell L. Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD. Aliment Pharmacol Ther. 2015 Dec;42(11-12):1261-70. doi: 10.1111/apt.13427. Epub 2015 Oct 13.