125I Seed-Loaded Stents and 125I Seed Strips for the Treatment of Unresectable Malignant Obstructive Jaundice

Abstract

Brachytherapy can provide longer obstruction-free time and prolonged survival in patients with unresectable malignant biliary obstruction (MBO). A randomized, single-blind, single-center trial was performed to compare the safety and efficacy of 125I seed-loaded stents to 125I seed strips for the treatment of unresectable MBO. Subjects diagnosed with MBO were divided randomly into two groups. Patients in group A were treated with 125I seed-loaded stents, patients in group B were treated with 125I seed strips. Study outcomes included post-operative complications, quality of life (QOL), time without biliary obstruction and survival. There were no significant differences in complications and morbidity that developed perioperatively. However, the incidence of post-operative complications was significantly higher in group B (n = 20) compared to group A (n = 19) (P < 0.05). Apart from those assessing pain (P = 0.91) and nausea and vomiting (P = 0.07), EORTC-QLQC30 scores in patients in group A were significantly higher than those reported for group B. The median time to relief of biliary obstruction was 144 ± 107 days (95% CI, [92.5–195] days) for group A and 231 ± 150 days (95% CI, [160.92–301.58] days) for group B (P = 0.045). Median survival time was 272.58 ± 258.73 days (95% CI, [147–397] days) for group A and 268 ± 143 days (95% CI, [201–335] days) for group B (P = 0.992). We observed no significant differences with respect to survival were. Although administration of 125I seed strips resulted in a prolonged period without biliary obstruction, use of the 125I seed-loaded stent implant was associated with a lower rate of complications and significantly improved QOL.