Clinical trials evaluating endoscopic GERD treatments: is it time for a moratorium on the clinical use of these procedures?
Perendoscopic treatments of gastroesophageal reflux have been used in clinical practice following FDA approval of the first two devices in 2000. A number of clinical trials predominantly short-term have been performed almost uniformly demonstrating patient improvement in GERD symptomatology and reduction or elimination of antacids. However, only two of these endo reflux treatment trials have included the essential elements of strict patient entry criteria, randomization, attempts at blending, and intention-to-treat analysis. Two new endoscopic antireflux trials are published in this issue of the journal. The first study compares the EndoCinch sewing device to the Enteryx copolymer injection procedure. The second report compares the EndoCinch technique to the laparoscopic fundoplication procedure. Unfortunately, both studies lack a sham-control population and have other important flaws in design. Basically, all these techniques improved GERD symptoms and well-being and decreased the patients PPI requirement during follow-up period. However, none of the endoscopic procedures reduced acid reflux impressively or improved lower esophageal sphincter tone, a consistent negative outcome with all these techniques. Morbidity was associated with all the procedures and Enteryx has been withdrawn recently from clinical use by the manufacturer because of significant complications. The efficacy durability and safety of these devices in treating GERD patients is in question. A moratorium on the continued use of the procedures in clinical practice seems appropriate at this time.
Hogan
Walter J
WJ
D018795:Device Approval; D004869:Equipment Safety; D004945:Esophagoscopy; D018662:Fundoplication / Q000295:instrumentation*; D005764:Gastroesophageal Reflux / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy; D010043:Outcome and Process Assessment, Health Care; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D016896:Treatment Outcome