Original ArticlesEndoscopic implantation of a biopolymer in the lower esophageal sphincter for gastroesophageal reflux: A pilot study☆,☆☆
Section snippets
Patients and methods
This study included 15 patients (mean age 52 years, range 36-72 years) treated in Brussels (n = 10) and Rome (n = 5) between June 1999 and June 2000. All patients had an established diagnosis of GERD including esophagitis and had required continuous therapy with a full-dose PPI for at least 3 months. The severity of heartburn at baseline was graded 10 days after cessation of PPI therapy as follows: 1, asymptomatic; 2, daily mild but noticeable symptoms; 3, moderate symptoms, bothersome every
Results
The characteristics of the 15 patients are shown in Table 1.All had symptoms that relapsed on discontinuation of PPI therapy. The volume of injection ranged from 4 to 6 mL of Enteryx in 1 to 6 injections. Mean procedure time was 20 minutes (range 15 to 30 min).
No complications occurred during the procedure. Eight patients had mild retrosternal pain for 1 to 3 days after the procedure that was treated with orally administered analgesics (tramadol hydrochloride, 150 mg/day). In all cases, pain
Discussion
The procedure used in this study has 2 novel features: the type of material injected, and the technique of injection.
The injected biopolymer has an extremely low viscosity that makes it easy to inject through a standard size needle. As described in animal studies, the material is distributed into the tissue as discrete implants that become encapsulated in the muscle several weeks after implantation.10 The biopolymer is nonbiodegradable and precipitates as a spongy mass. This latter
Acknowledgements
We thank Alan Stein, PhD, Myriam Delhaye, MD, and Jean-Marc Panzer, MD for their active participation in the study as well as Jeffrey Peters, MD, for useful comments.
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2007, Journal of Surgical ResearchLaparoscopic Nissen fundoplication after biopolymer injection: A case report
2006, Gastrointestinal EndoscopyCitation Excerpt :During the past few years, new endoscopic techniques for treatment of GERD have been described and approved by the Food and Drug Administration (FDA): endoscopic plication, radiofrequency application, and biopolymer injection into the LES.3 The injection solution consists of a biocompatible polymer, 8% ethyl vinyl alcohol dissolved in dimethyl sulfoxide as the solvent.4,5 This patient's injection therapy was performed endoscopically under fluoroscopic control.
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Supported by Enteric Medical Technology, Palo Alto, California.
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Reprint requests: J. Devière, MD, ULB—Hôpital Erasme, Department of Gastroenterology, Route de Lennik 808, B—1070, Brussels, Belgium.