A Study to Determine the Effectiveness of Endoscopic Full-Thickness Plication for the Treatment of GERD
NCT ID: NCT00575822
Last Updated: 2008-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
159 participants
INTERVENTIONAL
2005-01-31
2008-03-31
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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1
NDO Endoscopic Full-thickness Plicator procedure
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.
2
Sham control procedure
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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NDO Surgical, Inc.
INDUSTRY
Responsible Party
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NDO Surgical, Inc.
Principal Investigators
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Richard Rothstein, MD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center, Lebanon, NH
Charles Filipi, MD
Role: PRINCIPAL_INVESTIGATOR
Creighton University Medical Center, Omaha, NE
Karel Caca, MD
Role: PRINCIPAL_INVESTIGATOR
Klinikum Ludwigsburg, University of Heidelburg, Heidelburg, Germany
Ronald Pruitt, MD
Role: PRINCIPAL_INVESTIGATOR
Nashville Medical Research and the Maria Nathanson Center of Excellence, Nashville, TN
Klaus Mergener, MD
Role: PRINCIPAL_INVESTIGATOR
Digestive Health Specialists, Tacoma, WA
Alfonso Torquati, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center, Nashville, TN
Gregory Haber, MD
Role: PRINCIPAL_INVESTIGATOR
Lenox Hill Hospital, New York, NY
Yang Chen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado Health Science Center, Denver, CO
Kenneth Chang, MD
Role: PRINCIPAL_INVESTIGATOR
University of California at Irvine Medical Center, Orange, CA
David Wong, MD
Role: PRINCIPAL_INVESTIGATOR
Tri Valley Gastroenterology, San Ramon, CA
Jacques Deviere, MD
Role: PRINCIPAL_INVESTIGATOR
Erasme Hospital, Brussels, Belgium
Douglas Pleskow, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center, Boston MA
Charles Lightdale, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University Medical Center, New York, NY
Alain Ades, MD
Role: PRINCIPAL_INVESTIGATOR
Seacoast Gastroenterology, Exeter, NH
Richard Kozarek, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Mason Medical Center, Seattle, WA
Locations
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University of California at Irvine Medical Center
Orange, California, United States
Tri Valley Gastroenterology
San Ramon, California, United States
University of Colorado Health Science Center
Denver, Colorado, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Creighton University Medical Center
Omaha, Nebraska, United States
Seacoast Gastroenterology
Exeter, New Hampshire, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Lenox Hill Hospital
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Nashville Medical Research and the Maria Nathanson Center of Excellence
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Digestive Health Specialists
Tacoma, Washington, United States
Erasme Hospital
Brussels, , Belgium
Klinikum Ludwigsburg, University of Heidelburg
Heidelberg, , Germany
Countries
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References
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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.
Other Identifiers
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135-01885
Identifier Type: -
Identifier Source: org_study_id