Endoscopic intraluminal brachytherapy and metal stent in malignant hilar biliary obstruction: a pilot study

Malignant hilar biliary obstruction carries a poor prognosis, as the disease is often unresectable at the time of diagnosis. Various palliative measures as surgical/radiological/ endoscopic drainage with or without radiotherapy/chemotherapy have been tried with dismal outcome. We prospectively studied the effect of unilateral metal stent with intraluminal high dose rate (HDR) brachytherapy in patients with type II malignant hilar biliary obstruction.

Eight patients with type II malignant hilar biliary obstruction were treated with contrast-free unilateral metal stenting followed by endoscopic intraluminal brachytherapy (ILBT). A retrospectively analyzed group of 10 patients treated only with contrast-free unilateral metal stenting served as historical controls.

A successful drainage was achieved in all, cholangitis occurred in none and no patient died within 30 days in both groups. The mean (+/-SD) patency of metal stent was 305 (+/-183.96) days and 143.9(+/-115.11) days in patients with and without intraluminal brachytherapy, respectively (P=0.03). Mean (+/-SD) survival of these patients was 310 (+/-192.68) days and 154.9 (+/-122.51) days in patients with and without intraluminal brachytherapy, respectively (P=0.05). Kaplan-Meier analysis showed estimated median survival of 225 (95% CI; 169.5, 280.4) days in brachytherapy and 100 (95%CI; 94.1, 105.8) days in control group (P=0.025). No major complications related to metal stent or ILBT were observed.

Contrast-free unilateral metal stenting with HDR ILBT in type II malignant hilar biliary obstruction is a safe and effective method of palliation and appears to prolong patient survival as well as patency of stent in these patients, however, a larger, randomized trial is required to validate the same.