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

NCT00575822 | Terminated

• 1 other identifier: 135-01885
• Study Type: interventional
• Target: 159
• Locations: 3 countries
• Sites: 15

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).

Conditions

Gastroesophageal Reflux Disease (GERD)

Keywords

GERD; Sham; Randomized Controlled Study; Endoscopic Full-thickness Plication; Plicator

Outcome Measures

Primary Outcomes (1)

• >/=50% improvement in GERD-Health Related Quality of Life Score

  3-months post-procedure

Secondary Outcomes (4)

• GERD medication use

  3-months post-procedure

• Esophageal acid exposure

  3-months post-procedure

• Heartburn score as measure by visual analog scale

  3-months post-procedure

• Quality of Life as measure by SF-36

  3-months post-procedure

Study Arms (2)

1

ACTIVE COMPARATOR

NDO Endoscopic Full-thickness Plicator procedure

Device: NDO Full-thickness Plicator

2

SHAM COMPARATOR

Sham control procedure

Device: Sham Control

Interventions

NDO Full-thickness Plicator DEVICE

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.

Also known as: Active Plicator procedure

1

Sham Control DEVICE

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.

Also known as: Sham control procedure

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• NDO Surgical, Inc.: lead

Study Sites (15)

University of California at Irvine Medical Center

Orange, California, 92868, United States

Location

Tri Valley Gastroenterology

San Ramon, California, 94583, United States

Location

University of Colorado Health Science Center

Denver, Colorado, 80010, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

Seacoast Gastroenterology

Exeter, New Hampshire, 03833, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Lenox Hill Hospital

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Nashville Medical Research and the Maria Nathanson Center of Excellence

Nashville, Tennessee, 37205, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37240, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Digestive Health Specialists

Tacoma, Washington, 98405, United States

Location

Erasme Hospital

Brussels, Belgium

Location

Klinikum Ludwigsburg, University of Heidelburg

Heidelberg, 71640, Germany

Location

Related 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 disease: A randomized, sham-controlled trial. Gastroenterology. 2006 Sep;131(3):704-12. doi: 10.1053/j.gastro.2006.07.004.

  PMID: 16952539 RESULT

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Richard Rothstein, MD

  Dartmouth-Hitchcock Medical Center, Lebanon, NH

  PRINCIPAL INVESTIGATOR

• Charles Filipi, MD

  Creighton University Medical Center, Omaha, NE

  PRINCIPAL INVESTIGATOR

• Karel Caca, MD

  Klinikum Ludwigsburg, University of Heidelburg, Heidelburg, Germany

  PRINCIPAL INVESTIGATOR

• Ronald Pruitt, MD

  Nashville Medical Research and the Maria Nathanson Center of Excellence, Nashville, TN

  PRINCIPAL INVESTIGATOR

• Klaus Mergener, MD

  Digestive Health Specialists, Tacoma, WA

  PRINCIPAL INVESTIGATOR

• Alfonso Torquati, MD

  Vanderbilt University Medical Center, Nashville, TN

  PRINCIPAL INVESTIGATOR

• Gregory Haber, MD

  Lenox Hill Hospital, New York, NY

  PRINCIPAL INVESTIGATOR

• Yang Chen, MD

  University of Colorado Health Science Center, Denver, CO

  PRINCIPAL INVESTIGATOR

• Kenneth Chang, MD

  University of California at Irvine Medical Center, Orange, CA

  PRINCIPAL INVESTIGATOR

• David Wong, MD

  Tri Valley Gastroenterology, San Ramon, CA

  PRINCIPAL INVESTIGATOR

• Jacques Deviere, MD

  Erasme Hospital, Brussels, Belgium

  PRINCIPAL INVESTIGATOR

• Douglas Pleskow, MD

  Beth Israel Deaconess Medical Center, Boston MA

  PRINCIPAL INVESTIGATOR

• Charles Lightdale, MD

  Columbia University Medical Center, New York, NY

  PRINCIPAL INVESTIGATOR

• Alain Ades, MD

  Seacoast Gastroenterology, Exeter, NH

  PRINCIPAL INVESTIGATOR

• Richard Kozarek, MD

  Virginia Mason Medical Center, Seattle, WA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 14, 2007
• First Posted: December 18, 2007
• Study Start: January 1, 2005
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: July 16, 2008

Record last verified: 2008-05

Locations

BE (1); DE (1); US (13)