A NEW 12-FRENCH PLASTIC STENT MAY BE AN ALTERNATIVE TO METALLIC STENTS IN UNRESECTABLE DISTAL MALIGNANT BILIARY OBSTRUCTION

Aims To address the efficacy and safety of a new 12-French plastic stent (PS) in unresectable distal malignant biliary obstruction (DMBO).

Methods Observational, prospective, frequency matched case-control study. All consecutive patients who underwent biliary stenting by a 12-French plastic stent (PS) were considered as cases. A historical control cohort matched by sex, etiology and metastatic status included patients with 10-French PS, fully-covered SEMS (FCSEMS) and uncovered SEMS (UCSEMS).

The primary outcomes were the stent patency and the recurrent biliary obstruction (RBO) rate. Secondary outcomes were the technical success and 30-days mortality and adverse events. A post-procedure analysis by irrigation and dissection in removed analysis was done.

Results Seventy-two patients (median age: 66, range: 32-94 years, 50% male) were included (24 cases, 48 controls). There was no statistically significant difference in the stent patency median time between case-control patients (p=0.684). The RBO in the 12-French stent was lower (50%) compared to the 10-French profile (81.3%), and was significant (p=0.046). Conversely, there was no statistically significant difference between 12-French PSs and FCSEMSs in RBO (50% vs. 43.8%, p=0.698) or stent dysfunction rates (50% vs. 37.5%, p=0.436).

The technical success was 100% in all subgroups. The 30-days mortality in case-control groups were 12.5% and 2.1% (p=0.105). Adverse events were 4.2% in both groups. Overall survival was 240.4 days (±202).

Of 10 removed 12-French PSs suspected to be dysfunctional because of clogging, there were 4 (40%) confirmed occlusions and 6 (60%) were permeable.

Conclusions The 12-French PSs could be an alternative in DMBO, with comparable results to SEMSs and definitively better than 10-French PSs. 12-French stent dysfunction is overestimated.