Prospective multicenter international study on EUS-guided biliary drainage for patients with distal malignant biliary obstruction and failed endoscopic retrograde cholangiopancreatography (ERCP)

Background EUS-guided biliary drainage (EUS-BD) has emerged as an alternative to traditional radiologic and surgical drainage procedures. However, prospective multicenter data are lacking. Aims: The primary outcome of this prospective study (NCT01889953) was to assess the clinical success of EUS-BD. Secondary outcomes included technical success, rate and severity of adverse events, and long-term outcomes of EUS-BD. Methods All consecutive patients at 12 tertiary centers (5 US, 5 European, 1 Asian, 1 South American) with malignant distal (≥ 2cm from the hilum) biliary obstruction and failed ERCP underwent EUS-BD using either rendezvous (REN), direct transluminal (TL) [Choledochoduodenostomy (CDS), Hepatogastrostomy (HGS), Hepatoduodenostomy (HDS)], or antegrade (AG) stenting techniques. Technical success was defined as successful stent placement in the desired position. Clinical success was defined as drop in bilirubin by 50% at 2 weeks or to below 3 (level that allows patients to undergo chemotherapy) at 4 weeks. Adverse events were prospectively tracked and graded according to the ASGE lexicon's severity grading system. Overall survival and duration of stent patency were calculated using Kaplan-Meier estimate. Results A total of 95 patients (mean age 66yr, female 44%, pancreatic cancer 55%) underwent EUS-BD [REN 11, AG 12, TL 72 (CDS 53, HGS 15, HDS 4)]. Reason for EUS-BD was obscured ampulla by invasive cancer or enteral stent (n=49), altered anatomy (n=9), failed deep biliary cannulation (n=20), gastric outlet obstruction (n=17). Electrocautery was used during 66.67% of procedures (coaxial 38.67%, non-coaxial 28%). EUS-guided cholangiography was successful in 94 (99%) patients. Stent placement (technical success) was achieved in 91 (95.7%) patients (metallic stent 83, plastic stent 8). Mean procedure time was 41 minutes (range 8-207). Clinical success was achieved in 85 patients (95%, intention to treat; 89.4%, per protocol analysis). There was significant decrease in bilirubin (mg/dL) at 4 weeks (13.9 vs. 1.86, p<0.0001). A total of 10 (10.5%) adverse events occurred: pneumoperitoneum (n=2), sheared wire (n=1), bleeding (n=1), bile leak (n=3), cholangitis (n=2), and perforation (n=1): 4 graded as mild, 4 moderate, 1 severe, and 1 fatal (due to perforation). There were no predictive factors of clinical success or occurrence of adverse events (all p>0.05). A total of 24 (25%) patients died of disease progression during the study period. The median patient survival was 491 days. The mean stent patency was 536 days (95% CI 383-689) and the one-year stent patency was 61% (Figure 1). Conclusion This is the first prospective international multicenter study on EUS-BD and demonstrates the excellent efficacy and safety of EUS-BD when performed by experts. Based on these results, a study comparing EUS-BD to percutaneous drainage is being planned.