Aims Endoscopic ultrasound-guided biliary drainage (EUS-BD) has been associated with better
clinical outcomes and a lower rate of adverse events than fluoroscopically guided
percutaneous transhepatic biliary drainage (PTBD) in recent retrospective studies.
However, both procedures have not yet been compared in a prospective sufficiently
powered multicentre international study in adult patients with distal malignant bile
duct obstruction undergoing primary metal stenting after unsuccessful ERCP.
Methods The study protocol (PMID: 36302047) was designed as a non-inferiority, non-randomised,
controlled, European multicentre study with two parallel groups. Each of the 14 centres
in Spain and Germany used the intervention with the highest level of competence (US-guided
PTBD or EUS-guided transmural BD) as an intended one step-procedure with primary metal
stenting (NCT03546049).
Results Two hundred and twelve patients were recruited from December 2018 to August 2024
at five PTBD and 9 EUS-BD centres, resulting in 68 PTBDs and 141 EUS-BDs, respectively
(60 EUS-HGS, 59 EUS-CDS, 17 EUS-AGS, and 5 EUS-Rendezvous with ERCP). The baseline
characteristics of the patients (mean age: 73 years) were comparable with pancreatic
cancer as the main cause of distal malignant bile duct obstruction (63.6%) and gastric
outlet obstruction (49.3%) as the main cause of unsuccessful ERCP. Mean procedure
time (58.0 vs. 44.0 minutes) and hospital stay after initial procedure (9.4 vs. 7.5
days) were longer for PTBD than for EUS-BD. Technical success (97.2 vs. 91.2%) and
clinical success in the ITT analysis (76.3 vs. 70.6%) were better in EUS-BD than in
PTBD, except in the subgroup of EUS-HGS, where the clinical success rate was similar
to PTBD. The overall rate of adverse events (grade 1-4) was similar in both groups
(13.2% in PTBD vs. 16.3% in EUS-BD), including 6 fatal adverse events (death). There
was no significant increase in pain scores (VAS) in either arm. Six-month follow-up
data pending [1]
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Conclusions EUS-BD (EUS-HGS, EUS-CDS, EUS-AGS and EUS-Rendezvous with ERCP) showed overall slightly
better technical and clinical success than PTBD for distal malignant biliary obstruction
with intended primary metal stenting, except for EUS-HGS in the subgroup analysis.
The rate of adverse events was similar for both procedures.
