Original Articles
Endoscopic implantation of a biopolymer in the lower esophageal sphincter for gastroesophageal reflux: A pilot study,☆☆

https://doi.org/10.1067/mge.2002.121596Get rights and content

Abstract

Background: GERD is the most frequent disorder of the esophagus. Endoscopic minimally invasive treatment is desirable. However, the results of injection techniques have been disappointing. Methods: A pilot study was conducted in patients with GERD, who required continuous therapy with a proton pump inhibitor, in which ethylene-vinyl-alcohol was injected into the muscle of the gastric cardia. Primary endpoints were the safety of the procedure, the effect on lower esophageal sphincter pressure and the stability of the injected material. A secondary endpoint was the effect on heartburn score after discontinuation of treatment with a proton pump inhibitor. Results: Ethylene-vinyl-alcohol injection into the cardia resulted in circular diffusion of the product in 10 of 15 cases, suggesting that implantation into the muscle is feasible. Lower esophageal sphincter pressure was increased in 13 of 15 cases at 1 month and was sustained at a median follow-up of 6 months (range 4-12 months). Mean ± SEM of lower esophageal sphincter pressures (15 patients) were 12.2 ± 0.9, 18.7 ± 1.5 (p = 0.001 at baseline), and 16.7 ± 1.3 mm Hg (p = 0.038 from baseline) at, respectively, baseline, 1 month follow-up, and final follow-up. There was also a sustained reduction in heartburn score (off proton pump inhibitor) (3.40 ± 0.13 vs. 1.53 ± 0.24 and 1.87 ± 0.26 at baseline vs. 1 month and final follow-up, respectively; p < 0.01). Nine of the 15 patients had more than 50% of the injected material in place at second follow-up (at 6 months for 8 patients; at 12 months for 1 patient). In only 2 patients was there loss of more than 75% of injected ethylene-vinyl-alcohol. Persistence of greater than 50% of the material was associated with achievement of a circular injection. Only 4 patients had to resume therapy with a proton pump inhibitor. Mild retrosternal discomfort was observed in 8 patients; this disappeared in all cases after a maximum of 3 days. Conclusions: Ethylene-vinyl-alcohol implantation in the muscle of the cardia is feasible and safe. It leads to a sustained increase in resting lower esophageal sphincter pressure. This is associated with a sustained improvement in heartburn score for patients who previously required continuous therapy with a proton pump inhibitor. (Gastrointest Endosc 2002;55:335-41.)

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.

References (10)

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    Citation 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.

☆☆

Reprint requests: J. Devière, MD, ULB—Hôpital Erasme, Department of Gastroenterology, Route de Lennik 808, B—1070, Brussels, Belgium.

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