Clinical trial NCT00575822: A Study to Determine the Effectiveness of Endoscopic Full-Thickness Plication for the Treatment of GERD
Official title: Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: GERD
Sham
Randomized Controlled Study
Endoscopic Full-thickness Plication
Plicator
Lead sponsor: NDO Surgical, Inc.
Sponsor class: INDUSTRY
First posted: 2007-12-18
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study was to determine the effectiveness of endoscopic full-thickness plication (Plicator; NDO Surgical, Inc., Mansfield, MA) for the treatment of GERD in comparison to a sham procedure.

Patients with symptomatic GERD requiring maintenance proton pump inhibitor therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary endpoint was ≥ 50% improvement in GERD-HRQL score. Secondary endpoints included medication use and esophageal acid exposure.

Patients achieving ≥ 50% improvement in GERD-HRQL score at 3-months versus baseline off-meds were considered responsive to their assigned procedure. Patients who failed to reach this level of improvement at 3-months were considered non-responders. Analysis of these dichotomized variables (responder/non-responder) was done using Fisher's exact test comparing the proportion of responders between the active and sham groups. Intent-to-treat analysis was also performed. The null hypothesis was that the proportion of responders was the same in both the active and sham groups. Testing was done at the 5% level of significance (alpha=0.05).


Eligibility criteria: Patients 18 years or older with a history of heartburn or regurgitation symptoms requiring daily PPI therapy were recruited.

Inclusion Criteria:

* GERD-HRQL score ≥ 15 while off PPI therapy, and at least 6 points higher than on-PPI score
* Pathologic esophageal acid exposure, defined as pH\<4.0 ≥ 4.5% of a 24- or 48-hour monitoring period or a DeMeester score \> 14.7
* Lower esophageal resting pressure of at least 5mmHg; and
* Suitability for surgery (American Society of Anesthesiologists Physical Status Classification I or II).

Exclusion Criteria:

* Significant esophageal dysmotility as determined by manometry
* Esophagitis grade III or IV (Savary-Miller)
* Barrett's epithelium
* Hiatus hernia \> 2cm
* Persistent dysphagia, weight loss, esophageal bleeding, vomiting, gas or bloating
* Esophageal or gastric varices
* Previous endoscopic or surgical anti-reflux procedure
* Other esophageal or gastric surgery
* Chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis); and
* Pregnancy.

Primary outcomes:
measure: >/=50% improvement in GERD-Health Related Quality of Life Score
timeFrame: 3-months post-procedure
Secondary outcomes:
measure: GERD medication use
timeFrame: 3-months post-procedure
measure: Esophageal acid exposure
timeFrame: 3-months post-procedure
measure: Heartburn score as measure by visual analog scale
timeFrame: 3-months post-procedure
measure: Quality of Life as measure by SF-36
timeFrame: 3-months post-procedure
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California at Irvine Medical Center
state: California
city: San Ramon
country: United States
facility: Tri Valley Gastroenterology
state: California
city: Denver
country: United States
facility: University of Colorado Health Science Center
state: Colorado
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Exeter
country: United States
facility: Seacoast Gastroenterology
state: New Hampshire
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Nashville
country: United States
facility: Nashville Medical Research and the Maria Nathanson Center of Excellence
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Tacoma
country: United States
facility: Digestive Health Specialists
state: Washington
city: Brussels
country: Belgium
facility: Erasme Hospital
city: Heidelberg
country: Germany
facility: Klinikum Ludwigsburg, University of Heidelburg
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center, Lebanon, NH
name: Richard Rothstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Creighton University Medical Center, Omaha, NE
name: Charles Filipi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Ludwigsburg, University of Heidelburg, Heidelburg, Germany
name: Karel Caca, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nashville Medical Research and the Maria Nathanson Center of Excellence, Nashville, TN
name: Ronald Pruitt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Digestive Health Specialists, Tacoma, WA
name: Klaus Mergener, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center, Nashville, TN
name: Alfonso Torquati, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lenox Hill Hospital, New York, NY
name: Gregory Haber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Colorado Health Science Center, Denver, CO
name: Yang Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California at Irvine Medical Center, Orange, CA
name: Kenneth Chang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tri Valley Gastroenterology, San Ramon, CA
name: David Wong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasme Hospital, Brussels, Belgium
name: Jacques Deviere, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center, Boston MA
name: Douglas Pleskow, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University Medical Center, New York, NY
name: Charles Lightdale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seacoast Gastroenterology, Exeter, NH
name: Alain Ades, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Mason Medical Center, Seattle, WA
name: Richard Kozarek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rothstein R, Filipi C, Caca K, Pruitt R, Mergener K, Torquati A, Haber G, Chen Y, Chang K, Wong D, Deviere J, Pleskow D, Lightdale C, Ades A, Kozarek R, Richards W, Lembo A. Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: A randomized, sham-controlled trial. Gastroenterology. 2006 Sep;131(3):704-12. doi: 10.1053/j.gastro.2006.07.004.