Unilateral versus bilateral endoscopic hepatic duct drainage in patients with malignant hilar biliary obstruction: results of a prospective, randomized, and controlled study

Background: The necessity for drainage of both liver lobes in tumors arisin g at the biliary bifurcation is controversial. The aim of this study was to compare the outcome of unilateral versus bilateral drainage in patients wi th biliary obstruction at the hilum. Methods: One hundred fifty-seven consecutive patients with primary cholangi ocarcinoma, gallbladder cancer, or periportal lymph node metastases were ra ndomly allocated to unilateral (group A) or bilateral (group a) hepatic duc t drainage. Results: In intention-to treat analysis, group A had a significantly higher rate of successful endoscopic stent insertion than group a (88.6% vs. 76.9 %, p = 0.041), Group B had a significantly higher rate of complications tha n group A (26.9% vs. 18.9%, p = 0.026) because of the higher rate of early cholangitis (16.6% vs. 8.8%, p = 0.013). In per-protocol analysis the rate of successful drainage, complications, and mortality did not differ between the two groups. Median survival did not differ between the two groups but was significantly different for patients with cholangiocarcinoma and those with gallbladder cancer versus patients with metastatic tumors (p = 0.0247) . Conclusion: The insertion of more than one stent would not appear justified as a routine procedure in patients with biliary bifurcation tumors.