DOES CO-AXIAL PLASTIC DOUBLE PIG TAIL STENT PLACEMENT INTO LUMEN-APPOSING METAL STENTS REDUCE RISKS IN EUS-GUIDED DRAINAGE OF PANCREATIC FLUID COLLECTIONS?

Aims:

Endoscopic ultrasound (EUS)-guided lumen-apposing metal stents (LAMS) placement may facilitate pancreatic fluid collections (PFC) drainages but data on related-adverse events, particularly bleeding, are limited. Few data suggest that a co-axial plastic double pig tail stent (DPS) might reduce bleeding risk. Primary aim was the feasibility, efficacy and safety of Hot Axios(Boston Scientific) in a series of patients undergoing PFC EUS-guided drainage. Second aim was to assess the efficacy of DPS placement into the LAMS in order to decrease bleeding.

Methods:

A retrospective review of Hot Axios placement for PFC drainage in our Institute between Oct2014 and Sept2018 was performed. Patients demographics, PFC etiology and characteristics, technical success (TS), clinical success (CS) rate (< 50% PFC + symptoms resolution) and adverse events (± 7 days: immediate/delayed) were registered.

Results:

49 pts were identified. TS rate was 98%, CS rate 93.9%. Total adverse events were 16.3%. Bleeding rate was 10.2%(5/49): 3 early (arterial pseudoaneurysms-1 death), 2 delayed (1 hepatic artery branch vessel bleeding, 1 fatal WON cavity hemorrhage). 1 immediate perforation and 2"buried stent syndrome" occurred. DPS was positioned in 34.7%(17/49). Bleeding rate in patients with DPS was lower (1/17;5.9%) compared to patients without (5/32;15.6%), but this difference was not statistically significant (p = 0.65). “Other” complications rate also did not differ with or without DPS (p = 0.23). At logistic regression analysis PFC size, necrosis, access, sex, age and DPS presence were not significantly associated with complications/bleeding risk.

Conclusions:

Hot Axios PFC drainage is highly feasible and effective, with a relatively safe profile. Bleeding is a serious and potentially fatal complication. Although bleeding rate seems lower after DPS positioning (5.9% vs. 15.6%), if this difference is true, a power calculation with a β= 0.20 and an α= 0.10 suggests that a RCT would reach statistical significance with > 200 patients per arm. Further multicenter studies are needed to assess the possible DPS protective role in this setting.