Introduction
Endoscopic biliary drainage (EBD) is the standard of care for patients with malignant hilar biliary obstructions (MHBO) but is associated with a high risk of complications, such as pancreatitis or cholangitis. In a phase II trial of primary percutaneous stenting (PPS) for unresectable MHBO, the risk of severe drainage-related complications was 18% and none of 67 patients developed cholangitis or pancreatitis.(1)
Aims & Methods
The aim of this randomized controlled trial (RCT) was to compare PPS with EBD for patients with suspected unresectable MHBO. We performed an investigator-initiated, open-label phase III RCT in five Dutch academic centers.(2) Eligible patient presented with metastatic disease, locally advanced disease, or resectable disease with a poor performance status precluding surgery. Patients were randomly assigned 1:1 to PPS or EBD. PPS consisted of one or more uncovered self-expandable metal stents placed above the ampulla without leaving an external drain. EBD was performed according to international guidelines by experienced endoscopists. The primary endpoint was major complications within 90 days after randomization, defined as any complication with prolonged hospital stay (>72 hours), readmission, invasive reintervention, or death (including death due to disease progression). Secondary endpoints included technical success of initial stent placement, clinical success (i.e., bilirubin below 51 µmol/L or a reduction of >=50% within 14 days after the initial drainage procedure), severe drainage-related complications within 90 days, reinterventions within 90 days, palliative systemic treatment, and overall survival. Analyses were performed according to the intention-to-treat principle.
Results
Between August 2023 and June 2026, 148 patients were randomized to PPS (n=72) or EBD (n=76). This preliminary analysis of 143 patients (PPS 69, EBD 74) excluded five patients who have not yet reached 90-day follow-up. The median age was 71 years (IQR, 63-79) and 32 patients (22%) were ≥ 80 years. Patients had perihilar cholangiocarcinoma (n=73, 51%), intrahepatic cholangiocarcinoma (n=42, 29%), gallbladder cancer (n=11, 8%), liver metastases (n=12, 8%), or other tumors causing MHBO (n=5, 3%). The median bilirubin before drainage was 339 µmol/L in the PPS arm and 226 µmol/L in the EBD arm.
Major complications within 90 days occurred in 28 patients (41%) in the PPS arm versus 50 (68%) in the EBD arm (p=0.001). Technical success of stent placement at initial drainage was achieved in 66 patients (96%) after PPS versus 62 (84%) after EBD (p=0.021); clinical success after the initial drainage procedure was reached in 52 patients (75%) after PPS versus 49 (66%) after EBD (p=0.23). Severe drainage-related complications occurred in 13 patients (19%) after PPS versus 37 (50%) after EBD (p<0.001), including cholangitis in 2 (3%) versus 24 (32%, p<0.001), pancreatitis in 5 (7%) versus 0 (p=0.059), hemorrhage in 2 (3%) versus 1 (1%), and bile duct perforation in 5 (7%) versus 5 (7%). Reinterventions were performed in 10 patients (15%) after PPS versus 42 (57%) after EBD (p<0.001). Crossover was never performed in the PPS arm versus in 15 patients (20%) in the EBD arm. Palliative systemic treatment was initiated in 28 patients (41%) after PPS versus 22 (30%) after EBD (P=0.22). Survival at six months was 62% after PPS versus 44% after EBD (p=0.75).
Conclusion
PPS substantially reduced major complications and reinterventions within 90 days compared to EBD in patients with unresectable MHBO.
References
1. Franssen S, Rousian M, van Verschuer V, et al. Primary percutaneous stenting for palliative biliary drainage of patients with malignant hilar biliary obstruction: TESLA trial. JHEP Rep. 2025;7(11):101541. Published 2025 Sep 11. doi:10.1016/j.jhepr.2025.101541
2. Rousian M, van Verschuer V, Franssen S, et al. Primary percutaneous stenting above the ampulla versus endoscopic drainage for unresectable malignant hilar biliary obstruction (TESLA RCT): study protocol for a multicenter randomized controlled trial. BMC Cancer. 2025;25(1):849. Published 2025 May 9. doi:10.1186/s12885-025-14158-0
Disclosure
This abstract presents the results of the preliminary analysis on August 18th. All patients have been randomized and treated. But 5 patients are still within the 90 days follow-up period and therefore not yet evaluable for the primary outcome. On September 24th, all patients will have at least 90 days follow-up. We will then run the definitive analyses according to the statistical analysis plan. Those results will be available for presentation at UEG. It is unlikely that the results will change in a meaningful way.