Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) with stent placement is the current standard for drainage of distal malignant biliary obstruction (MBO), but carries a significant risk of post-procedural pancreatitis.[1] EUS-guided choledochoduodenostomy (EUS-CDS) is increasingly used as a promising alternative, but comparative studies are still scarce.[2,3] While previous studies have mainly focused on stent patency, the current study aims to evaluate whether EUS-CDS is superior to ERCP in achieving a textbook outcome for the patients, indicating an optimal post-procedural course.

Aims & Methods

This single-center study included patients with distal MBO who underwent technically successful (1) EUS-CDS with a lumen apposing metal stent (LAMS) plus additional coaxial stent or (2) ERCP with fully covered self-expandable metal stent (FCSEMS) as part of the prospective SCORPION studies and SPHINX trial, respectively.[1,4] The primary endpoint was textbook outcome, defined as the absence of procedure- or stent-related adverse events (AEs), reinterventions, or hospital readmissions within 30 days of the procedure. Secondary endpoints included individual components of the primary outcome, mortality, time to initiation of treatment (e.g., systemic therapy or surgery), and textbook outcome at 90 days.

Results

A total of 144 patients were enrolled for EUS-CDS (n=49) or ERCP (n=95). Primary etiologies included pancreatic cancer (n=117, 81%) and distal cholangiocarcinoma (n=14, 10%). Coaxial stents used in the EUS-CDS group were FCSEMS (n=20) or double pigtail plastic stents (n=29). Textbook outcome was achieved in 44 patients (90%) in the EUS-CDS group and in 67 patients (71%) in the ERCP group at 30 days (RR 1.27, 95% CI 1.08-1.50). EUS-CDS led to fewer procedure- or stent-related AEs (RR 0.35, 95% CI 0.14-0.84) compared with ERCP, particularly post-procedure pancreatitis (0% vs. 23%). Other AEs, including perforation (2% vs. 0%), bleeding (0% vs. 0%), stent dysfunction with or without cholangitis (4% vs. 6%), and cholecystitis (4% vs. 3%) were similar between groups. Hospital readmission rate was lower in the EUS-CDS group (6% vs. 30%, RR 0.21, 95% CI 0.07-0.65), as was the length of hospital stay (mean 0.3 days [SD 1.3] vs. 1.8 days [SD 4.0], P=0.01). In-hospital mortality (8% vs. 5%), need for reinterventions (8% vs. 6%), and time to treatment initiation, either surgery or chemotherapy, did not differ (median 33 days [IQR 23-42] vs. 30 days [IQR 18-41]). At 90 days, textbook outcome was more often present in the EUS-CDS group when compared to ERCP however the difference was no longer significant (78% vs. 69%, RR 1.22, 95% CI 1.02-1.44).

Conclusion

EUS-CDS with LAMS and additional coaxial stent was superior to ERCP with FCSEMS in achieving textbook outcome at 30 days post-procedure. EUS-CDS resulted in less procedure- or stent-related AEs, particularly post-procedure pancreatitis, and consequently in fewer hospital readmissions and shorter hospital stay. Therefore, when expertise is available, EUS-CDS with coaxial stent placement could be considered as primary biliary drainage technique in patients with distal MBO.

References

1. Onnekink, A. M., Gorris, M., Bekkali, N. L., et al (2024). Endoscopic sphincterotomy to prevent post-ERCP pancreatitis after self-expandable metal stent placement for distal malignant biliary obstruction (SPHINX): a multicentre, randomised controlled trial. Gut, gutjnl-332695. https://doi.org/10.1136/gutjnl-2024-332695
2. Teoh, A. Y. B., Napoleon, B., Kunda, R et al (2023). EUS-Guided choledocho-duodenostomy using lumen apposing stent versus ERCP with covered metallic stents in patients with unresectable malignant distal biliary obstruction: a multicenter randomized controlled trial (DRA-MBO trial). Gastroenterology, 165(2), 473-482.e2. https://doi.org/10.1053/j.gastro.2023.04.016
3. Chen, Y., Sahai, A., Donatelli, G. et al (2023). 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, 165(5), 1249-1261.e5. https://doi.org/10.1053/j.gastro.2023.07.024
4. Fritzsche, J. A., Fockens, P., Besselink, M. G. et al (2024). Optimizing EUS-guided choledochoduodenostomy with lumen-apposing metal stents for primary drainage of malignant distal biliary obstruction (SCORPION-IIp): a prospective pilot study. Gastrointestinal Endoscopy. https://doi.org/10.1016/j.gie.2024.10.012

Disclosure

Paul Fockens acted as a consultant for Cook Endoscopy and Olympus, outside the submitted work.
Roy L.J. van Wanrooij acted as a consultant for Boston Scientific. Jeanin E. van Hooft has received research support from Cook Medical and acted as lecturer for Cook Medical, Boston Scientific and Falk, and as consultant for Olympus. Rogier P. Voermans received a research grant and acted as consultant for Boston Scientific. All outside the submitted work. All other authors declare that they have no competing financial interests or personal relationships that could have appeared to influence the work reported in this abstract.

Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) is a key procedure in managing biliary and pancreatic disorders. In cases of difficult cannulation (DC), when standard cannulation techniques (SCT) fail, precut sphincterotomy (PS) may be used as an alternative technique, often by experienced endoscopists. PS has been shown to improve cannulation success rates, but its use has been associated with an increased risk of adverse events, including post-ERCP pancreatitis (PEP), perforation, and bleeding. Despite this it is argued that it might be safer to proceed with PS early rather than to traumatise the papilla with continuous attempts with SCT. DC is defined as cannulation taking more than 5 minutes, more than 5 attempts or accidently entering the pancreatic duct with a guidewire more than once and is known to be associated with more complications than non-DC. The aim of this study was to compare outcomes of PS versus SCT in cases of DC, regarding complication rates and successful cannulation.

Aims & Methods

Data were retrieved from the Swedish National Register for Gallstone surgery and ERCP, GallRiks from September 2016 to December 2023. A total of 30,561 ERCPs, performed as index ERCPs without rendezvous technique, were identified and cross-checked. Logistic regression analyses were conducted, adjusting for endoscopist and clinic volume using generalized estimating equations.

Results

Altogether 9,909 procedures were classified as DC among which 3,005 (30%) were performed with PS, compared to 434 (2%) of 20,218 in the non-DC group. In DC the rate of pancreatitis was 9.4%, cholangitis 2.3%, bleeding 1.4%, bile leakage 1.9% and perforation 0.7%. PS was not associated with increased risk of procedure related complications in DC. The rate of successful cannulation in DC was 87.9% when SCT were used and 70.4% when PS was performed.

Conclusion

PS is a safe technique in ERCP when cannulation is difficult and is not associated with an increased risk of complications compared to SCT.