Optimizing EUS-guided choledochoduodenostomy with lumen-apposing metal stents for primary drainage of malignant distal biliary obstruction (SCORPION-IIp): a prospective pilot study.

BACKGROUND AND AIMS: Biliary drainage by ERCP in patients with malignant distal bile duct obstruction (MBO) is frequently associated with adverse events, such as pancreatitis, hampering patient outcomes. EUS-guided choledochoduodenostomy (EUS-CDS) with a lumen-apposing metal stent (LAMS) is a promising alternative in patients with MBO but is associated with a worrisome risk of stent dysfunction. Placement of a fully covered self-expandable metal stent (FCSEMS) through the LAMS, thereby changing the axis of biliary drainage toward the descending duodenum, may decrease the risk of stent dysfunction while maintaining high technical success and low adverse event rates.

METHODS: This was a prospective single-center pilot study in patients with pathology-confirmed MBO without gastric outlet obstruction. The primary outcome was stent dysfunction, defined as recurrent jaundice after initial clinical success, ongoing jaundice in combination with persistent bile duct dilatation, or cholangitis.

RESULTS: Overall, 27 consecutive patients eligible for EUS-CDS were enrolled. The placement of a LAMS was successful in 24 of 27 patients (89%), and placement of a FCSEMS through the LAMS was successful in 20 of 24 (83%); in the remaining 4 patients, a coaxial double-pigtail plastic stent was placed. Two of these 20 patients experienced persistent jaundice requiring stent revision (10%), leading to a clinical success rate of 90%. No patients developed stent dysfunction after initial clinical success.

CONCLUSIONS: This study showed a stent dysfunction rate of 10% after technically successful EUS-CDS with placement of a FCSEMS through the LAMS. Improving the design of LAMSs may further reduce the rate of stent dysfunction. (Clinical trial registration number: NCT05595122.).