A Study to Determine the Effectiveness of Endoscopic Full-Thickness Plication for the Treatment of GERD

Gastroesophageal Reflux Disease (GERD) Clinical Trial

Official title:

Endoscopic Full-Thickness Plication for the Treatment of Gastroesophageal Reflux Disease: A Randomized, Sham-Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00575822
• Other study ID #: 135-01885
• Status: Terminated
• Phase: N/A
• First received: December 14, 2007
• Last updated: July 15, 2008
• Start date: January 2005
• Est. completion date: March 2008

Study information

• Verified date: May 2008
• Source: NDO Surgical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 159
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease (GERD)

Intervention

Device:
• NDO Full-thickness Plicator
A low-profile (=6mm) gastroscope was advanced and an EGD followed by Savary wire placement was performed. The gastroscope was then removed and the Plicator was advanced directly over the wire and into the stomach. The gastroscope was re-introduced through the Plicator, and the Plicator was retroflexed under direct endoscopic visualization to the anterior gastric cardia, approximately 1cm below the gastroesophageal (GE) junction. The Plicator arms were opened and the endoscopic tissue retractor was advanced deeply into the gastric cardia. The gastric wall was then retracted into the open arms of the Plicator. The arms were closed and a single, transmural pledgeted suture was deployed. The Plicator and gastroscope were then removed and the gastroscope re-inserted to evaluate the post-plication GE junction.
• Sham Control
The sham procedure was identical to the treatment procedure through the positioning of the retroflexed Plicator 1cm below the GE junction. The Plicator instrument remained in this position for 15 minutes, based on average procedure times established in previous studies. During the sham procedure, physician investigators were required to talk through the procedure steps to maintain the patient blind.

Locations

Country	Name	City	State
Belgium	Erasme Hospital	Brussels
Germany	Klinikum Ludwigsburg, University of Heidelburg	Heidelberg
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University of Colorado Health Science Center	Denver	Colorado
United States	Seacoast Gastroenterology	Exeter	New Hampshire
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Nashville Medical Research and the Maria Nathanson Center of Excellence	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	Creighton University Medical Center	Omaha	Nebraska
United States	University of California at Irvine Medical Center	Orange	California
United States	Tri Valley Gastroenterology	San Ramon	California
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Digestive Health Specialists	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
NDO Surgical, Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Germany, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	>/=50% improvement in GERD-Health Related Quality of Life Score		3-months post-procedure	No
Secondary	GERD medication use		3-months post-procedure	No
Secondary	Esophageal acid exposure		3-months post-procedure	No
Secondary	Heartburn score as measure by visual analog scale		3-months post-procedure	No
Secondary	Quality of Life as measure by SF-36		3-months post-procedure	No