Authors' objectives:

The objective of this review was to assess the safety and efficacy of the following endoscopic anti-reflux treatments currently used for treating GORD: Radiofrequency energy ablation (Stretta Procedure). Endoluminal gastroplication (Bard EndoCinch, Wilson-Cook Endoscopic Suturing Device and NDO Plicator). Injection/implantation techniques (Enteryx, Gatekeeper Reflux Repair System and Plexiglas).

Authors' results and conclusions: Limited evidence suggested that in a select group of patients the Stretta Procedure produces improvements in symptoms and quality of life that are comparable to laparoscopic fundoplication and superior to sham treatment. Another intervention is generally required in up to 10% of patients two years after treatment. The main advantage of the Stretta Procedure is that it causes fewer serious complications than fundoplication and rarely requires general anaesthetic. Results from a single RCT comparing EndoCinch to sham treatment indicated a significant placebo effect, but EndoCinch reduced oesophageal exposure and medication usage more than the sham procedure. Evidence from three small non-randomised comparative studies suggested that EndoCinch provided the same or slightly inferior results, compared to laparoscopic fundoplication. Although EndoCinch was associated with a re-intervention rate of up to 55% within two years, patients had fewer serious adverse events following EndoCinch than laparoscopic fundoplication. Two small case series studies on the NDO Plicator noted a positive effect on symptom and quality of life scores and medication usage between six and twelve months after treatment. Evidence from a small RCT suggested that Enteryx has a substantial placebo effect. Up to a quarter of patients may need re-treatment within two years. A single RCT that compared Enteryx and EndoCinch found no significant difference in safety or efficacy between the two treatments. Enteryx was recalled by the manufacturer in September 2005 after serious adverse events and one death were reported after the procedure. One case series study reported improvements in symptoms, quality of life and medication usage six months after treatment with the Gatekeeper Reflux Repair System. The evidence for Plexiglas was sketchy, with only one very small case series study reporting modest improvements at an average of seven months after treatment. Both procedures were relatively safe.

Authors' recommendations: The scope, applicability, efficacy and cost effectiveness of endoscopic anti-reflux therapies for the treatment of GORD have not been established. These procedures may provide an alternative treatment for selected patients with mild to moderate GORD who are dependent on medication and are reluctant or unable to undergo surgery. However, a substantial placebo effect has been demonstrated in sham controlled trials, and endoscopic results were generally inferior when compared with laparoscopic fundoplication. Doubts about the durability of the therapeutic effect remain since the follow-up period in most studies was short. Clearly defined patient selection criteria and concurrently controlled studies assessing the affect of these endoscopic techniques in particular patient groups, especially with respect to medication usage, will help resolve the question of where these procedures fit in the spectrum of treatment choices available for patients with GORD. While the endoscopic anti-reflux procedures are relatively safe when performed in the setting of a clinical trial, their use in routine clinical practice should be closely monitored. Guidance from professional bodies, such as the Upper Gastrointestinal section of the Royal Australasian College of Surgeons and the relevant section of the Gastroenterological Society of Australasia, on the minimum training requirements for performing these procedures would be helpful.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.surgeons.org/Content/NavigationMenu/Research/ASERNIPS/default .htm

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Australian Safety and Efficacy Register of New Interventional Procedures-Surgical

Contact Address: ASERNIP-S 24 King William Street, Kent Town SA 5067 Australia Tel: +61 8 8219 0900

Contact Name: racs.asernip@surgeons.org

Contact Email: racs.asernip@surgeons.org

Copyright: Australian Safety and Efficacy Register of New Interventional Procedures - Surgical