Clinical trial NCT01136980: Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
Official title: A Randomized Controlled Trial Comparing Transoral Incisionless Fundoplication (TIF) Using EsophyX With Sham Procedure for the Treatment of PPI Dependent GERD Compared With Sham and Placebo Controls
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: 2010-06-04
Enrollment: 129
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 objective of the study is to evaluate the relative merits, safety and effectiveness of the EsophyX transoral device in performing an advanced TIF procedure in patients with "troublesome symptoms" as defined by the Montreal consensus definition while on PPIs compared with sham and placebo controls.

Detailed description: Primary Effectiveness Endpoint: A clinically significant reduction in GERD symptoms, specifically "Troublesome" regurgitation with or without heartburn assessed by the Reflux Disease Questionnaire (RDQ).

Troublesome symptoms are those which occur a minimum of 2 days a week and are at least moderate in severity.

Secondary Effectiveness Endpoint: The normalization of esophageal acid exposure at 6 months and a clinically significant reduction in PPI usage at 12 months.

Eligibility criteria: Inclusion Criteria:

* Age 18-80 years
* Dependent upon daily PPIs for \> 6 months
* Troublesome symptoms, specifically heartburn or regurgitation, while on 40 mg of omeprazole or equivalent.

Troublesome heartburn or regurgitation symptoms are those which occur a minimum of 2-3 days a week and are at least moderate in severity.

* Abnormal ambulatory pH study off PPI therapy for 7 days.
* Normal or near normal esophageal motility (by manometry)
* Hiatal hernia axial height is no larger than 2 cm and the transverse dimension should not exceed 2.5 cm
* Patient willing to cooperate with post-operative dietary recommendations and assessment tests
* Signed informed consent

Exclusion Criteria:

* BMI \> 35
* Hiatal hernia \> 2 cm
* Esophagitis Los Angeles grade C or D
* Esophageal ulcer
* Esophageal stricture
* Esophageal motility disorder
* Pregnancy or plans for pregnancy in the next 12 months (in females)
* 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
* Interprocedural determination of anatomical presentation which in the opinion of the surgeon does not allow safe device introduction.

Primary outcomes:
measure: Number of Participants With a Clinically Significant Reduction in Gastroesophageal Reflux Disease (GERD) Symptoms (Specifically "Troublesome" Regurgitation With or Without Heartburn as Assessed by the RDQ Per the Montreal Consensus Definition,
timeFrame: 6 month follow up
Secondary outcomes:
measure: Normalization of Esophageal Acid Exposure - as Measured by DeMeester Score
timeFrame: 6 months post procedure
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Englewood
country: United States
facility: SurgOne PC
state: Colorado
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Columbus
country: United States
facility: Ohio State University Hospital
state: Ohio
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Houston
country: United States
facility: University of Texas, Health Science Center at Houston
state: Texas
city: Reston
country: United States
facility: Reston Surgical Associates
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Oregon Health and Science University
name: John Hunter, MD FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hunter JG, Kahrilas PJ, Bell RC, Wilson EB, Trad KS, Dolan JP, Perry KA, Oelschlager BK, Soper NJ, Snyder BE, Burch MA, Melvin WS, Reavis KM, Turgeon DG, Hungness ES, Diggs BS. Efficacy of transoral fundoplication vs omeprazole for treatment of regurgitation in a randomized controlled trial. Gastroenterology. 2015 Feb;148(2):324-333.e5. doi: 10.1053/j.gastro.2014.10.009. Epub 2014 Oct 13.