Introduction
Distal malignant biliary obstruction (DMBO) is a serious diagnosis that often results in significant morbidity and mortality due to development of obstructive jaundice and related complications. Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) has been described as a salvage therapy for patients with DMBO following unsuccessful ERCP and/or EUS-guided biliary drainage [1,2]. EUS-GBD leverages the proximity of the gallbladder to the gastrointestinal lumen to establish a new passage for biliary drainage, which offers a viable and potentially safer alternative to current EUS-BD techniques, particularly when the gallbladder is distended [3]. There is a paucity of data reporting on the outcomes of EUS-GBD for this indication, limited by small cohorts and single-centre design. We report a multi-centre study of outcomes for EUS-GBD performed for DMBO in non-surgical candidates.
Aims & Methods
A review of a prospectively collected database of 28 EUS-GBD cases was performed between 2017 and 2024 at two referral centres in New Zealand. At both centres, patients were consented for biliary drainage via ERCP, EUS-BD, and/or EUS-GBD prior to sedation so that drainage could be achieved in a single anaesthetic session. Ethics approval was provided at participating centres before commencement. Included participants were adults diagnosed with DMBO who had unsuccessful ERCP and/or EUS-BD, and a patent hepatocystic junction. A transduodenal approach was universal, using electrocautery-enhanced lumen apposing metal stents (LAMS), and propofol-assisted anaesthesia. Technical success (TS), clinical success (CS), length of hospital stay (LOS), adverse events (AEs), reinterventions, and survival were recorded. CS was defined by improvement in biochemistry and symptoms within 72 hours. AEs were categorised into serious and non-serious events. Re-interventions were categorised into early (<7 days) or delayed (≥7 days) procedures. Follow up duration was from time of intervention until patient death.
Results
Mean age was 74 years with 32.1% females. Pancreatic cancer was the most common diagnosis. Mean Charlson comorbidity index was 9.8 ± 1.4 and mean ASA physical status classification was 3.9 ± 0.5. The 10mm LAMS was most commonly used (78.6%), with co-axial plastic stent placement performed in 25%. TS and CS was achieved in all cases. Pre-procedure bilirubin improved from mean 126 ± 115 umol/L to 63 ± 49 umol/L at 72 hours. There were no intra-procedural complications and no early reinterventions recorded. Mean LOS was 3 ± 3 days. There were 9 non-serious AEs, all infective in aetiology and treated with antibiotics. 5 serious AEs were recorded (cholangitis (n=1), recurrent obstruction (n=3) and LAMS obstruction (n=1)) and only these cases required reintervention. These were treated with ERCP (n=1), percutanous drainage (n=3), and stent removal (n=1) respectively. No repeat procedure was required in 23/28 (82.1%) patients. Median cohort survival was 135 days.
Conclusion
EUS-GBD offers excellent TS and CS as a salvage therapy for DMBO in the second or third-line setting. Furthermore, it is safe with a favourable AE profile, short LOS and low rate of reintervention. This is particularly important in this cohort of patients with advanced malignancy. EUS-GBD offers a durable therapy and can be used as destination platform for other DMBO therapeutics. We have also demonstrated feasibility of sequential deployment within the same interventional session as ERCP and EUS-BD procedures creating a streamlined process for limiting cumulative anaesthetic exposures.
References
1. Imai, H., et al., EUS-guided gallbladder drainage for rescue treatment of malignant distal biliary obstruction after unsuccessful ERCP. Gastrointestinal endoscopy, 2016. 84(1): p. 147-151.
2. Debourdeau, A., et al., Effectiveness of endoscopic ultrasound (EUS)‐guided choledochoduodenostomy vs. EUS‐guided gallbladder drainage for jaundice in patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography: Retrospective, multicenter study (GALLBLADEUS Study). Digestive Endoscopy, 2024.
3. Kamal, F., et al., Efficacy and safety of EUS-guided gallbladder drainage for rescue treatment of malignant biliary obstruction: A systematic review and meta-analysis. Endoscopic ultrasound, 2023. 12(1): p. 8-15.