Randomized EsophyX Versus Sham / Placebo Controlled TIF Trial: The RESPECT Study
RESPECT
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
1 other identifier
interventional
129
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2011
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2010
CompletedFirst Posted
Study publicly available on registry
June 4, 2010
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedResults Posted
Study results publicly available
December 3, 2021
CompletedDecember 3, 2021
December 1, 2021
4 years
June 2, 2010
November 12, 2020
December 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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,
Primary efficacy Hypothesis 1: At 6-month follow-up, the proportion of Transesophageal Incisionless Fundoplication (TIF)2+Placebo pts who are free of "troublesome" symptoms will be statistically significantly larger than those randomized to the Sham+PPI (Proton Pump Inhibitor) treatment group.
6 month follow up
Secondary Outcomes (1)
Normalization of Esophageal Acid Exposure - as Measured by DeMeester Score
6 months post procedure
Study Arms (2)
Sham placebo procedure
PLACEBO COMPARATORSham Procedure: SHAM/PPI's An upper GI Endoscopy is performed with a standard endoscope, during 30-45 minutes. The patient is under general anesthesia. EGD explores the esophagus, the stomach, and the GEJ.
TIF Transoral Fundoplication
ACTIVE COMPARATORIntervention: TIF 2.0/Placebo TIF Transoral Incisionless Fundoplication: A fundoplication of 270 degrees and 3cm in length was created. The EsophyX device is introduced over a standard endoscope, through the mouth, into the stomach.
Interventions
A novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions)
The Sham Procedure (control) will consist of an upper GI endoscopy that will be conducted under general anesthesia in an operating room. The surgical team will follow the same steps before, during, and after the sham procedure similar to the TIF procedure, except they will never insert the EsophyX device into the patient. The endoscope will be manipulated for 30-45 min as if the device were around it to simulate the effect of many rotations and manipulations on the esophagus.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
SurgOne PC
Englewood, Colorado, 80110, United States
Northwestern University
Chicago, Illinois, 60611, United States
Ohio State University Hospital
Columbus, Ohio, 43211, United States
The Oregon Clinic
Portland, Oregon, 97210, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Texas, Health Science Center at Houston
Houston, Texas, 77401, United States
Reston Surgical Associates
Reston, Virginia, 20190, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
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.
PMID: 25448925DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Intent to treat (ITT) analysis included 12 patients with limited follow-up data. Assessment of the primary end point at 6 months can be viewed as premature by some; however, we believed it likely that delaying the primary end point beyond 6 months would risk patients not entering or dropping out of the study prematurely.
Results Point of Contact
- Title
- Adrain Lobontiu
- Organization
- EndoGastric Solutions
Study Officials
- PRINCIPAL INVESTIGATOR
John Hunter, MD FACS
Oregon Health and Science University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2010
First Posted
June 4, 2010
Study Start
April 1, 2011
Primary Completion
April 1, 2015
Study Completion
March 1, 2018
Last Updated
December 3, 2021
Results First Posted
December 3, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share