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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | NDO Endoscopic Full-thickness Plicator procedure |
|
| 2 | Sham Comparator | Sham control procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| >/=50% improvement in GERD-Health Related Quality of Life Score | 3-months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| GERD medication use | 3-months post-procedure | |
| Esophageal acid exposure | 3-months post-procedure | |
| Heartburn score as measure by visual analog scale |
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Patients 18 years or older with a history of heartburn or regurgitation symptoms requiring daily PPI therapy were recruited.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California at Irvine Medical Center | Orange | California | 92868 | United States | ||
| Tri Valley Gastroenterology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16952539 | Result | 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. |
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| 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. |
|
|
| 3-months post-procedure |
| Quality of Life as measure by SF-36 | 3-months post-procedure |
| 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 | 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 |
| San Ramon |
| California |
| 94583 |
| United States |
| University of Colorado Health Science Center | Denver | Colorado | 80010 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Creighton University Medical Center | Omaha | Nebraska | 68131 | United States |
| Seacoast Gastroenterology | Exeter | New Hampshire | 03833 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Lenox Hill Hospital | New York | New York | 10021 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Nashville Medical Research and the Maria Nathanson Center of Excellence | Nashville | Tennessee | 37205 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37240 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Digestive Health Specialists | Tacoma | Washington | 98405 | United States |
| Erasme Hospital | Brussels | Belgium |
| Klinikum Ludwigsburg, University of Heidelburg | Heidelberg | 71640 | Germany |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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