Comparing the Safety and Efficacy of Intraluminal Brachytherapy vs Isolated Percutaneous Transhepatic Biliary Drainage with internalization for Unresectable Malignant Biliary Obstruction: A Prospective Observational Study.

Abstract

Background and objectives: Intraluminal therapies, including brachytherapy, can locally destroy obstructing tumors and increase the duration of catheter/stent patency in patients with unresectable malignant biliary obstruction (MBO). In this prospective observational study, the safety and efficacy of percutaneous transhepatic biliary drainage (PTBD) followed by HDR intraluminal brachytherapy (ILBT) in the palliative treatment of malignant biliary obstruction was evaluated.

Patients and methods: In total, 66 MBO patients (January 2021 to March 2022) who were unfit for alternate treatment modalities were enrolled in our study and underwent percutaneous transhepatic biliary drainage (PTBD) with internalization. Additionally, 11 patients underwent subsequent ILBT, which was administered over two sessions (800 cGy each session, one week apart) with iridium-192 prescribed at 1.5 cmfrom the central axis of the catheter via a percutaneous biliary catheter. The second session was followed up by endoluminal stenting in the same sitting. Patients with an Eastern Cooperative Oncology Group (ECOG) status <4 and a 50% decline in bilirubin/<5 mg/dL on day 10 after PTBD were selected for ILBT. The biliary stent/catheter patency period, survival duration, mean bilirubin level (mg/dL) decline, and incidence of complications were evaluated.

Results: Among the sixty-six patients included and classified into ILBT or PTBD-only groups, the median survival period for the ILBT group vs PTBD group was 172 (84.5-273.5) days vs 45 (30.75-83) days (p ≤ 0.0001) with an overall survival (OS) at 6 months of 62.34% vs 3.64% (p ≤ 0.0001). The stent/catheter patency period of the ILBT group in comparison to the PTBD group was 172 (83-273.5) days vs 30 (20-42.5) days (p ≤ 0.0001). No major treatment-related complications were observed in any of the patients.

Conclusions: ILBT with stenting is a safe option for improving stent patency and survival duration with minimal complications with the condition that patients are carefully selected.