EUS-guided choledochoduodenostomy for primary drainage of malignant distal biliary obstruction (SCORPION-II-p): a prospective pilot study using FCSEMS through LAMS

Aims EUS-guided choledochoduodenostomy (EUS-CDS) with a lumen-apposing metal stent (LAMS) is an alternative for ERCP in patients with a malignant distal biliary obstruction (MBO). [1] [2] The main drawback of EUS-CDS using LAMS is the high rate of stent dysfunction which leads to cholangitis and reinterventions. [3] [4] Presumably, the short length and perpendicular angle of the LAMS to the bile duct contribute to the risk of stent dysfunction. [5] Therefore, the aim was to investigate whether placement of a fully covered self-expandable metal stent (FCSEMS) through the LAMS, thereby changing the axis of biliary drainage towards the descending duodenum, will decrease the risk of stent dysfunction while maintaining high technical success and low adverse event rates.

Methods We performed a prospective pilot study in patients with proven MBO and a bile duct diameter of at least 12mm, requiring biliary drainage, excluding patients with gastric outlet obstruction. Patients underwent biliary drainage with (as first procedure) EUS-CDS using a 6 or 8 mm LAMS with a 6 cm by 8 or 10 mm FCSEMS placed through the LAMS. Primary outcome was stent dysfunction, defined as recurrent jaundice after initial clinical success, ongoing jaundice in combination with persistent dilatation of the bile ducts, or cholangitis. Secondary outcomes were technical success, clinical success, and adverse events (AEs).

Results Overall, 27 consecutive patients with MBO were enrolled with a median bile duct diameter of 16 mm (IQR 15-18) and bilirubin level of 224 µmol/L (IQR 182-336.5) prior to the intervention. All tumor stages were included.

Technical success of EUS-CDS with LAMS was achieved in 24/27 patients (89%), placement of FCSEMS through the LAMS was successful in 20/24 (83%), in the remaining 4 patients a coaxial double pigtail stent (DPS) was placed. Periprocedural AEs occurred in 3 patients (11%) due to LAMS maldeployment which was solved intraprocedurally in all patients. In 1 patient this led to biliary peritonitis and fluid collections requiring percutaneous drainage, the other 2 patients recovered uneventfully.

Clinical success was achieved in 18/20 patients (90%). In 2 patients with LAMS with FCSEMS there was persistent cholestasis in need of stent revision (10%). Stent dysfunction was not observed in any of the other patients (8% in total cohort [2/24]). Two patients experienced cholecystitis within 30 days after the procedure (10%), one patient who also had concomitant kidney failure subsequently deceased. The other patient recovered after antibiotics and percutaneous drainage. Two other patients deceased within 30 days which was unrelated to the procedure.

Conclusions This study showed a stent dysfunction rate of 10% following technically successful EUS-CDS with placement of a FCSEMS through the LAMS. Improving the LAMS design may reduce the rate of stent dysfunction by improving the direction of bile flow through the stent towards the descending duodenum.

Conflicts of interest

Jeska A. Fritzsche, Marc G. Besselink, Olivier R.C. Busch and Freek Daams have no conflicts of interest or financial ties to disclose. Freek Daams reports research grants from Medtronic, and received speaker ‘s fees from Medtronic, and proctoring fees from Intuitive. Paul Fockens performed as a consultant for Olympus and Cook Endoscopy. Johanna W. Wilmink reports research grants from Servier, Merck, Nordic and Astra Zeneca. Rogier P. Voermans reports research grants from Boston Scientific and Prion Medical, performed as a consultant for Boston Scientific, and received speaker’s fees from Mylan and Zambon. Roy L.J. van Wanrooij performed as a consultant for Boston Scientific. All outside the submitted work.

• References

• 1 Teoh AYB, Napoleon B, Kunda R. et al. EUS – guided choledocho-duodenostomy using lumen apposing stent versus ERCP with covered metallic stents in patients with unresectable malignant distal biliary obstruction. A multi-center randomized controlled trial. (DRA-MBO trial). Gastroenterology. 2023
• 2 Chen YI, Sahai A, Donatelli G. et al. Endoscopic Ultrasound-Guided Biliary Drainage of First Intent With a Lumen-Apposing Metal Stent vs Endoscopic Retrograde Cholangiopancreatography in Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Study (ELEMENT Trial). Gastroenterology. 2023
• 3 Vanella G, Bronswijk M, Dell'Anna G. et al. Classification, risk factors, and management of lumen apposing metal stent dysfunction during follow-up of endoscopic ultrasound-guided choledochoduodenostomy: Multicenter evaluation from the Leuven-Amsterdam-Milan Study Group. Dig Endosc 2023; 35 (03) 377-88
• 4 Fritzsche JA, Fockens P, Besselink MG. et al. Endoscopic ultrasound-guided choledochoduodenostomy using single-step lumen-apposing metal stents for primary drainage of malignant distal biliary obstruction (SCORPION-p): a prospective pilot study. Endoscopy. 2023
• 5 El Chafic AH, Shah JN, Hamerski C. et al. EUS-Guided Choledochoduodenostomy for Distal Malignant Biliary Obstruction Using Electrocautery-Enhanced Lumen-Apposing Metal Stents: First US, Multicenter Experience. Dig Dis Sci 2019; 64 (11) 3321-7

Publikationsverlauf

Artikel online veröffentlicht:
15. April 2024