Introduction

Post-procedural pancreatitis (PPP) is the most common adverse event associated with endoscopic retrograde cholangiopancreatography (ERCP). Endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) using a lumen-apposing metal stent is emerging as a promising approach for managing malignant distal biliary obstruction (MDBO), offering the potential to lower the risk of PPP. We compared the outcomes of EUS-CDS with ERCP when used as the primary modality for biliary decompression.

Aims & Methods

This was a multicenter randomized controlled study, enrolling consecutive patients admitted for obstructive jaundice due to malignant distal biliary obstruction with dilated common bile duct (CBD>15mm). Patients were randomly allocated to receive EUS-CDS or ERCP for primary biliary drainage. This was a superiority trial with post-procedural acute pancreatitis (abdominal pain, elevation in pancreatic enzymes, and hospitalisation) as primary outcome. Other outcomes included technical success, clinical success, adverse events, 6-months stent patency rate, and overall survival. Analyses were performed according to intention-totreat principles.

Results

Between April 2021 and October 2023, 220 patients were enrolled in the study (EUS-CDS group: 111; ERCP group: 109). EUS-CDS group showed a lower risk for post-procedural acute pancreatitis (1.8% in EUS-CDS group vs 7.3% in ERCP group; RR: 0.25, 95%CI 0.07-0.88). Technical success was achieved in 94.6% in EUS-CDS group vs 78.9% ERCP group (p value: <0.001), in a mean procedural time of 13.5+11.6 minutes, and 24.7+14.9 minutes, respectively (p value: <0.001). No differences were found in other adverse events, clinical success, stent patency, or overall mortality

Conclusion

EUS-CDS is superior to ERCP in reducing post-procedural acute pancreatitis risk, without significantly affecting the overall risk of adverse events. Additionally EUS-CDS showed improved technical success, and comparable clinical efficacy. These results support the use of EUS-CDS as the potential preferred primary approach in patients with dilated CBD (NCT04099862).

Introduction

Preoperative biliary drainage (PBD) is commonly used in patients with malignant distal biliary obstruction (MDBO) to maintain performance status, prevent cholangitis and allow subsequent surgical or neoadjuvant treatment. Endoscopic retrograde cholangiopancreatography (ERCP) is the first-line approach, but in cases of failure, percutaneous transhepatic biliary drainage (PTBD) or endoscopic ultrasound-guided biliary drainage (EUS-BD) are considered. While EUS-BD has shown favourable outcomes compared to PTBD in the palliative setting, evidence comparing these modalities in the preoperative setting is limited.

Aims & Methods

The aim of this study was to compare the efficacy, safety, and surgical outcomes of PTBD and EUS-BD in patients with MDBO after failed ERCP. This retrospective multicenter study included patients who underwent PTBD or EUS-BD followed by pancreaticoduodenectomy (PD) for periampullary cancer at 15 referral centers in Japan between January 2012 and December 2021. Only patients who had failed or were not amenable to ERCP were included. The primary outcome was surgery-related adverse events (AEs), while secondary outcomes included drainage efficacy, recurrence patterns, disease-free survival (DFS), and overall survival (OS). Propensity score matching (PSM) was used to adjust for baseline differences.

Results

In total, 2350 patients received PBD before PD. Of the 79 patients in whom ERCP failed, 65 underwent PTBD and 14 underwent EUS-BD. After PSM, 13 matched pairs were analyzed. Technical and clinical success rates were comparable between groups. However, the EUS-BD group had a significantly higher internalization success rate (100% vs. 46%, P=0.005) and fewer drainage sessions required (median: 1 vs. 2, P=0.015). The EUS-BD group also had a significantly shorter hospital stay for drainage (11 vs. 17 days, P=0.042). Rates of drainage-related AEs tended to be lower in the EUS-BD group, although not statistically significant. Surgery-related outcomes, including operative time, intraoperative blood loss, R0 resection rate, postoperative hospital stay, and surgery-related AEs, were not significantly different between groups. No cases of needle tract seeding were observed. Median DFS and OS were comparable between groups (DFS: 14.2 vs. 16.8 months, P=0.22; OS: 17.9 vs. 27.9 months, P=0.167).

Conclusion

EUS-BD showed comparable surgical outcomes and long-term oncological efficacy to PTBD, while offering superior internalization success, fewer interventions, and a shorter preoperative hospital stay. These advantages make EUS-BD a favorable alternative to PTBD in the preoperative management of MDBO after failed ERCP, particularly in patients scheduled for neoadjuvant therapy.

Disclosure

Kitano M has received grants from Boston Scientific, Zeon Medical Inc., and Medicos Hirata Inc. Takenaka M, Shiomi H, Kitagawa K, Shintani S, Maruyama H, Sagami R, Ikeura T, Ogura T, Ishida Y, Mandai K, Sugimori S, Imamura Y, Masuda A, Ikezawa K,Shimizu A, Nakai A, Nagai M and Nakano R have no conflicts of interest or financial ties to disclose.

Introduction

Malignant biliary obstruction (MBO) often necessitates endoscopic retrograde cholangiopancreatography (ERCP) for biliary drainage. Although ERCP is standard treatment, post-procedural infections such as cholangitis and cholecystitis remain clinically important. Current guidelines recommend prophylactic antibiotics only for high-risk cases. Clinically, MBO is categorized into distal malignant biliary obstruction (DMBO) and hilar malignant biliary obstruction (HMBO), depending on whether the obstruction involves the extrahepatic duct or the intrahepatic duct/hilar confluence. While several studies have supported the use of prophylactic antibiotics in HMBO, evidence remains limited for DMBO. This study aimed to evaluate the effect of prophylactic antibiotics on post-ERCP infectious complications in DMBO.

Aims & Methods

We retrospectively reviewed patients who underwent initial ERCP with stent placement for DMBO at five Japanese centers between January 2020 and September 2024. Patients were grouped based on the use or non-use of prophylactic antibiotics for ERCP. Propensity score matching (1:1) was performed using clinically relevant covariates. In addition, a sensitivity analysis was conducted via multivariable logistic regression on the before matched data to further assess the robustness of the findings. The primary outcome was the incidence of infectious complications (cholangitis or cholecystitis) within five days of ERCP.

Results

A total of 508 patients (304 in the antibiotic group, 204 in the non-antibiotic group) were included in the study. After PSM, 165 patients were selected for each group. Characteristics of the antibiotic vs. non-antibiotic groups included: median age 74 years in both groups; sex 92 (55.8%) males vs. 94 (57.0%) males; pancreatic cancer 129 (77.2%) cases vs. 133 (79.6%) cases; plastic stents 72 (43.6%) cases vs. 69 (41.8%) cases.
In the matched population, the incidence of overall infectious complications (cholangitis or cholecystitis) was significantly lower in the prophylactic antibiotic group than in the non-antibiotic group (3.6% vs. 10.3%; risk difference (RD), 6.7%; p=0.029), corresponding to a number needed to treat (NNT) of 14.9. No significant difference was observed in the rate of post-ERCP pancreatitis: 10 patients (6.1%) in the non-antibiotic group and 16 patients (9.7%) in the antibiotic group (p = 0.307). Sensitivity analysis using multivariable logistic regression confirmed that absence of prophylactic antibiotics was independently associated with a higher risk of infectious complications (odds ratio: 2.45, 95% confidence interval: 1.22–4.92).

Conclusion

Prophylactic antibiotics significantly reduce post-ERCP infectious complications in patients with DMBO.