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

Study Overview
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Brief Summary
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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).

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

Conditions
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Gastroesophageal Reflux Disease (GERD)

Intervention / Treatment
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* Device: NDO Full-thickness Plicator
* Device: Sham Control


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>NDO Endoscopic Full-thickness Plicator procedure | Device: NDO Full-thickness Plicator<br>* 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.<br>* Other names: Active Plicator procedure;|
| Sham Comparator: 2<br>Sham control procedure | Device: Sham Control<br>* 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.<br>* Other names: Sham control procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| >/=50% improvement in GERD-Health Related Quality of Life Score |  | 3-months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 3-months post-procedure | 
| Quality of Life as measure by SF-36 |  | 3-months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Sham, Randomized Controlled Study, Endoscopic Full-thickness Plication, Plicator