Clinical benefit of radiation therapy and metallic stenting for unresectable hilar cholangiocarcinoma

Table 1 Patient characteristics

	Patient group
	Radiotherapy	BSC	Resection	Pvalue
Cases	28	11	25
Gender (M/F)	14/14	4/7	20/5
Mean age (yr)	70.1 ± 9.7 (52-86)	74.0 ± 9.0 (61-90)	67.0 ± 9.7 (55-78)
Reason for non-resection				> 0.9999
Tumor factor	21	9	-
Patient factor	7	2	-
Performance status
0	12	3	17
1	15	6	8
2	1	2	0
TNM stage				0.4953
1a	0	0	7
1b	2	2	1
2a	1	0	3
2b	1	1	8
3	24	8	6
Bismuth classification				0.2332
1	3	0	2
2	6	3	2
3	7	6	10
4	12	2	11

No statistically significant differences in patient characteristics were observed among the resection, radiotherapy, and BSC groups. The mean age of the BSC patients was higher than that of the other groups, but the difference was not significant. TNM: Tumor, node, metastasis; BSC: Best supportive care.

Table 2 Details of biliary drainage and anti-cancer therapy

	Patient group
	Radiotherapy	BSC	Pvalue
Cases	28	11
Biliary metallic stenting	24	10
Drainage area			0.0630
Bilateral	14	2
Unilateral	10	8
Insertion route			0.0339
Endoscopic	4	6
Percutaneous	20	4
PTBD only	3	1	> 0.9999
No need for drainage	1	0	> 0.9999
Anti-cancer therapy
Radiotherapy	28	-
Extra corporeal (50 Gy)	28	-
Intra bile duct (24 Gy)	11	-
Additional chemotherapy	16	-
Gemcitabine	1	-
S-1	6	-
5FU-based regimen	9	-

Three patients in the radiotherapy group and one in the BSC group did not receive a metallic stent but underwent PTBD alone; cholangitis occurred after endoscopic stenting, and patients were treated with PTBD. A total of 16 patients were administered additional systemic chemotherapy, with 9 receiving a 5-fluorouracil (5FU)-based regimen, 6 receiving S-1, and 1 receiving gemcitabine. PTBD: Percutaneous transhepatic biliary drainage; BSC: Best supportive care.

Table 3 Results of metallic stenting

	Patient group
	Radiotherapy	BSC	Pvalue
Cases	23	11
Mean stent patency (d)1	604 ± 78.3	235 ± 53.3	0.0038
Median stent patency (d)1	557	358
Stent obstruction (%)	12 (56.5)	4 (36.4)	0.4646
Mean patent period	329.2 ± 234.8	136.8 ± 147.1	0.1472
Cause
Tumor ingrowth	9	1	0.1133
Tumor overgrowth	1	1	0.5490
Sludge	2	2	0.5799

¹Mean and median stent patency were calculated using the Kaplan-Meier method and compared using the log rank test. Stent patency was significantly longer in the radiotherapy than in the BSC group. Mean patent period was longer in the radiotherapy than in the BSC group, but the difference was not significant. BSC: Best supportive care.