AIHTA - Publications - Search - Endoscopic plication therapy in patients with gastroesophageal reflux disease (GERD)

Grössmann, N. and Wolf, S. and Wild, C. (2021): Endoscopic plication therapy in patients with gastroesophageal reflux disease (GERD). Decision Support Document 127.

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Gastroesophageal reflux (GERD) is one of the most common health problems, affecting approximately 10-20% of the western world population. Although the majority of patients respond to proton pump inhibitor (PPI) therapy, approximately 42% of GERD patients are dissatisfied with PPI treatment and are potential candidates for surgical therapy options.

This systematic review aimed to analyse whether endoscopic plication systems are more effective and equally safe than currently used standard treatments (PPI medication and laparoscopic surgery) for the treatment of GERD patients. The focus was on the following three endoscopic devices which are currently available on the market: ultrasound endoscopic endostapler (MUSE TM), transoral incisionless fundoplication (EsophyXZ®) and endoscopic full-thickness plication (GERDx TM).

A total of; six randomised controlled trials (RCTs), one non-randomised controlled trial and (NRCT) and one prospective single-arm study were included for the analysis. Regarding clinical effectiveness, for the outcome health-related quality of life (HRQoL) conflicting results could be observed across studies. Considering heartburn and regurgitation symptoms, one study showed statistically significant improvements in the intervention group compared to the control group (laparoscopic surgery). With regard to the safety profile of endoscopic therapies, no differences were found compared to the respective comparators. However, both the quality and the level of detail of the available safety data were insufficient.

Due to the very low quality of the currently available evidence and the use of predecessor device generations, the inclusion of endoscopic plication systems in the Austrian hospital benefit catalogue is currently not recommended. Larger study cohorts and longer follow-up times of comparative studies investigating the latest device generations will be necessary in the future to be able to draw solid conclusions about the efficacy and safety of endoscopic plication systems.

Item Type:Decision Support Document
Keywords:Gastroesophageal reflux, endoscopic plication, MUSE, EsophyXZ, GERDx, heartburn
Subjects:W Health professions > W 100-275 Medical, dental and pharmaceutical service plans
WB Practice of medicine > WB 300-962 Therapeutics
WI Digestive system > WI 250 Oesophagus
WO Surgery > WO 500-517 Operative surgical procedures. Techniques
WO Surgery > WO 505 Minimally invasive surgical procedures
Series Name:Decision Support Document 127
Deposited on:15 Jul 2021 07:28
Last Modified:15 Jul 2021 07:28

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