We analyzed 64 patients with locally advanced
hilar cholangiocarcinoma, including 25 who underwent resection (17 curative and 8 non-curative), 28 treated with
radiotherapy, and 11 who received best supportive care (BSC). The
radiotherapy group received EBRT (50 Gy, 30 fractions), with 11 receiving an additional 24 Gy (4 fractions) ILBT by
iridium-192 with remote after loading. ILBT was performed using percutaneous transhepatic biliary drainage (
PTBD) route. Uncovered metallic
stents (UMS) were inserted into non-resected patients with
obstructive jaundice, with the exception of four patients who received percutaneous transhepatic biliary drainage only. UMS were placed endoscopically or percutaneously, depending on the initial drainage procedure. The primary endpoints were patient death or
stent occlusion. Survival time of patients in the
radiotherapy group was compared with that of patients in the resection and BSC groups.
Stent patency was compared in the
radiotherapy and BSC groups.
RESULTS: No statistically significant differences in patient characteristics were found among the resection,
radiotherapy, and BSC groups. Three patients in the
radiotherapy group and one in the BSC group did not receive UMS insertion but received
PTBD alone;
cholangitis occurred after endoscopic stenting, and patients were treated with
PTBD. A total of 16 patients were administered additional systemic
chemotherapy (
5-fluorouracil-based regimen in 9, S-1 in 6, and
gemcitabine in 1). Overall survival varied significantly among groups, with median survival times of 48.7 mo in the surgery group, 22.1 mo in the
radiotherapy group, and 5.7 mo in the BSC group. Patients who underwent curative resection survived significantly longer than those who were not candidates for surgery (P = 0.0076). Cumulative survival in the
radiotherapy group was significantly longer than in the BSC group (P = 0.0031), but did not differ significantly from those in the non-resection group. Furthermore, the median survival time of patients in the
radiotherapy group who were considered for possible resection (excluding the seven patients who were not candidates for surgery due to comorbid disease or age) was 25.9 mo.
Stent patency was evaluated only in the 24 patients who received a metallic
stent.
Stent patency was significantly longer in the
radiotherapy than in the BSC group (P = 0.0165). Biliary drainage was not eliminated in any patient. To determine the efficacy of ILBT, we compared survival time and
stent patency in the EBRT alone and EBRT plus ILBT groups. However, we found no significant difference in survival time between groups or for
stent patencies. Hemorrhagic
gastroduodenal ulcers were observed in 5 patients (17.9%), three in the EBRT plus ILBT group and two in the EBRT alone group.
Ulcers occurred 5 mo, 7 mo, 8 mo, 16 mo, and 29 mo following
radiotherapy. All patients required hospitalization, but
blood transfusions were unnecessary. All 5 patients recovered following the administration of anti-
ulcer medication.
CONCLUSION: