Biliary Drainage in Patients With Unresectable, Malignant Obstruction Where ERCP Fails

BACKGROUND: Endoscopic retrograde cholangiopancreatography may fail because of malignant involvement of the second portion of the duodenum and the major papilla. Alternatives include percutaneous transhepatic biliary drainage (PTBD) or surgical bypass. Endoscopic ultrasonography-guided choledochoduodenostomy (EUS-CD) has been reported as an alternative. OBJECTIVE: To prospectively compare EUS-CD and PTBD in patients with unresectable malignant biliary obstruction. DESIGN: Prospective and randomized study. SETTING: Tertiary center. MAIN OUTCOME MEASUREMENTS: Success and efficacy comparison EUS-CD with PTBD. RESULTS: Twenty-five subjects were randomized (13 EUS-CD and 12 PTBD). Mean age was 67 years (SD, 11. 9). The 2 groups were similar before intervention in terms of quality of life EUS-CD (58. 3) vs. PTBD (57. 8) ; P=0. 78, total bilirubin (16. 4 vs. 17. 2; P=0. 7), alkaline phosphatase (539 vs. 518; P=0. 7), and gamma-glutamyl transferase (554. 3 vs. 743. 5; P=0. 56). All procedures were technically and clinically successful in both groups. At 7-day follow-up there was a significant reduction in total bilirubin in both the groups (EUS-CD, 16. 4 to 3. 3; P=0. 002 and PTBD, 17. 2 to 3. 8; P=0. 01), although no difference was noted comparing the 2 groups (EUS-CD to PTBD; 3. 3 vs. 3. 8; P=0. 2). There was no difference between the complication rates in the 2 groups (P=0. 44), EUS-CD (2/13; 15. 3%) and PTBD (3/12; 25%). Costs were similar in the 2 groups also (5673-EUS-CD vs. 7570-PTBD; P=0. 39). LIMITATIONS: Small sample size and single center study. CONCLUSIONS: EUS-CD can be an effective and safe alternative to PTBD with similar success, complication rate, cost, and quality of life.