Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease using multiple Plicator implants: 12-month multicenter study results
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The full-thickness Plicator® (Ethicon Endosurgery, Sommerville, NJ, USA) was developed for endoscopic treatment of gastroesophageal reflux disease (GERD). The goal is to restructure the antireflux barrier by delivering transmural pledgeted sutures through the gastric cardia. To date, studies using this device have involved the placement of a single suture to create the plication. The purpose of this study was to evaluate the 12-month safety and efficacy of this procedure using multiple implants to restructure the gastroesophageal (GE) junction.
A multicenter, prospective, open-label trial was conducted at four tertiary centers. Eligibility criteria included symptomatic GERD [GERD Health-Related Quality-of-Life (GERD-HRQL) questionnaire, off of medication], and pathologic reflux (abnormal 24-h pH) requiring daily proton pump inhibitor therapy. Patients with Barrett’s epithelium, esophageal dysmotility, hiatal hernia >3 cm, and esophagitis (grade III or greater) were excluded. All patients underwent endoscopic full-thickness plication with linear placement of at least two transmural pledgeted sutures in the anterior gastric cardia.
Forty-one patients were treated. Twelve months post treatment, 74% of patients demonstrated improvement in GERD-HRQL scores by ≥50%, with mean decrease of 17.6 points compared with baseline (7.8 vs. 25.4, p < 0.001). Using an intention-to-treat model, 63% of patients had symptomatic improvements of ≥50%, with mean GERD-HRQL decrease of 15.0 (11.0 vs. 26.0, p < 0.001). The need for daily proton pump inhibitor (PPI) therapy was eliminated in 69% of patients at 12 months on a per-protocol basis, and 59% on an intention-to-treat basis. Adverse events included postprocedure abdominal pain (44%), shoulder pain (24%), and chest pain (17%). No long-term adverse events occurred.
Endoscopic full-thickness plication using multiple Plicator implants can be used safely and effectively to improve GERD symptoms and reduce medication use.
KeywordsDigestive GORD/GERD (Gastro-oesophageal reflux disease) Hernia Barrett-s oesophagus, oesophageal Therapeutic/palliation, endoscopy Endoscopic reflux therapy
Conflict of interest statement
The authors Daniel von Renteln, Ingolf Schiefke, Karl-Hermann Fuchs, Susanne Raczynski, Michael Philipper, Wolfram Breithaupt, and Horst Neuhaus declare that they have no conflict of interest including any financial interest in the product being discussed.
Karel Caca declares that he has served in the capacity as a member of the NDO Surgical, Inc. Medical Advisory Board from October 3, 2006, to October 3, 2007 and has received honoraria for speaking and training. Research funding was granted by NDO Surgical, Inc, Mansfield, MA. Research funding contained material support (Plicator device and sutures), financing of the Plicator procedures, and costs for data processing and statistical analysis by QST Consultations, Ltd. (Allendale, MI).
Endoscopic full-thickness plication and hernia repair utilizing three implants (WMV 11474 kb)
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