Interventional procedure overview of endoluminal gastroplication for gastro-oesophageal reflux disease

Existing assessments of this procedure

A 2021 systematic review undertaken as part of a Health Technology Assessment from the Austrian Institute for Health Technology Assessment assessing the efficacy and safety of this procedure has been included in the summary of key evidence (Grössmann 2021).

The final conclusion from this HTA was that "the inclusion in the catalogue of benefits is currently not recommended" for this procedure. The reasoning for this was that "the current evidence is not sufficient to prove that endoscopic plication is more effective and equally safe or equally effective and safer than laparoscopic surgery, PPI therapy and/or sham treatment in chronic GORD patients. Due to the methodological shortcomings of the available evidence no solid conclusions can be drawn neither for clinical effectiveness nor for the safety of endoscopic plication therapy. Hence, there is a need for high-quality studies showing consistent long-term effectiveness results as well as properly reported and detailed safety data."

A guideline from the European Society of Gastrointestinal Endoscopy (ESGE) on the endoscopic management of gastrointestinal motility disorders was published in 2019. The ESGE "recommends against the widespread clinical use of transoral incisionless fundoplication (TIF) as an alternative to proton pump inhibitor (PPI) therapy or anti reflux surgery in the treatment of gastro-oesophageal reflux disease (GORD), because of the lack of data on the long-term outcomes, the inferiority of TIF to fundoplication, and its modest efficacy in only highly selected patients. TIF may have a role for patients with mild GORD who are not willing to take PPIs or undergo anti reflux surgery." This was a strong recommendation based on a moderate quality of evidence (level of agreement 92.8%).

The ESGE also "recommends against the use of the Medigus ultrasonic surgical endostapler (MUSE) in clinical practice because of insufficient data showing its effectiveness and safety in patients with GORD. MUSE should be used in clinical trials only". This was a strong recommendation based on a low quality of evidence (level of agreement 100%) (Weusten 2020).

An expert panel recommendation on treatment for distinct GORD symptoms characterised by unresponsiveness to PPI therapy was published in the American Journal of Gastroenterology in 2018. The panel stated that TIF was "not judged appropriate in any scenario" due to "the lack of long-term data demonstrating sustained and consistent efficacy" (Yadlapati 2018).

A guideline from the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) concerning endoluminal treatments for GORD was published in 2013 and updated in 2017. The recommendation given said "Based on existing evidence, TIF can be done with an acceptable safety risk in appropriately selected patients. The procedure leads to better control of GORD symptoms compared with PPI treatment in the short term (6 months) but appears to lose effectiveness during longer term follow up and is associated with moderate patient satisfaction scores. Objective GORD measures improve similarly after TIF 2.0 compared with PPI. No comparative, controlled trials exist between TIF and surgical fundoplication, but preliminary evidence suggests that the latter can be used safely after TIF failure." This was a strong recommendation based on a moderate quality of evidence (Pearl 2017).

A guideline from the American Society for Gastrointestinal Endoscopy (ASGE) on the role of endoscopy in the management of GORD was published in 2015. The ASGE recommends that "endoscopic anti reflux therapy be considered for selected patients with uncomplicated GORD after careful discussion with the patient regarding potential adverse effects, benefits, and other available therapeutic options." This recommendation was based on a low quality of evidence (Muthusamy 2015).