Two trials have shown the safety and efficacy of MSE for antegrade and total enteroscopy respectively1,2. The use of MSE in real-life settings outside MSE-expert centres and safety and effectiveness of MSE in post-surgical patients and patients with altered anatomy had not yet been investigated. The SAMISEN trial (NCT03955081) enrolled 10 European centres with a variety of MSE experience3.
For the core analysis, 251 patients were included, and 47 patients were allocated to the training phase for novel MSE users. Primary endpoint was a non-inferior safety profile of the procedure, defined as a serious adverse event (SAE) rate <8%. Dr Torsten Beyna (Evangelic Hospital Düsseldorf, Germany) presented the results. MSE demonstrated favourable safety outcomes. The overall SAE rate was 2.3% (95% CI 0.9-4.8). The core phase had an SAE rate of 2.0% and the training phase had an SAE rate of 4.3%. The SAEs included a perforation and a deep mucosal laceration of the oesophagus.
Subgroup analysis showed that within the postsurgical/altered anatomy subgroup the SAE rate was 1.9%, representing only 1 case out of 53 participants. In 9.6% of the patients AEs occurred, mostly related to clinically asymptomatic mucosal lacerations at the level of the oesophagus, the cardia, and the small bowel. The anatomic region of interest was reached in 88% of the performed procedures, total enteroscopy was successful in >50% of the patients that were planned for this procedure (n=81). The diagnostic yield of MSE was 83% and the therapeutic yield was 60.2% in this study.