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, p0.05). 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.