The baseline characteristics of the BBDC group and the control group are well balanced (Table 1). The technical success rate in both groups was 100%. None of the 125I seeds were lost during the delivery and deployment as well as in vivo implantation process. The median estimated radiation doses for the reference points of the BBDC group and the control group were 85.14 ± 4.72 Gy and 44.35 ± 3.55Gy (P<0.05), as calculated by computer TPS over one month and the total number of 125I seeds embedded in the patients of both groups was 38.84 ± 2.45 and 18.86 ± 2.75, respectively (P<0.05)
Table 1
Characteristics
|
Control group
(n = 39)
|
BBDC group
(n = 34)
|
P value
|
Age
|
57.05 ± 8.73
|
59.21 ± 7.22
|
0.408†
|
Sex
|
|
|
1.000*
|
Male
|
24
|
21
|
|
female
|
15
|
13
|
|
Clinical symptom
|
|
|
0.983*
|
Jaundice with poor appetite
|
21
|
19
|
|
Jaundice with emaciation
|
11
|
9
|
|
Jaundice with recurrent fever
|
7
|
6
|
|
Location of the tumor
|
|
|
0.495*
|
Middle bile duct
|
13
|
16
|
|
Distal bile duct
|
17
|
11
|
|
Hilar bile duct
|
9
|
7
|
|
Stenosis length (mm), mean ± SD
|
31.31 ± 5.90
|
29.07 ± 7.76
|
0.343†
|
Reason for unresectability
|
|
|
0.720*
|
Metastases
|
17
|
13
|
|
Local infiltration
|
12
|
14
|
|
Refusal/intolerance to surgical treatment
|
10
|
7
|
|
* Pearson chi-square test was used. |
† Independent samples t test was used. |
Clinical Success
The hospital stay of the BBDC group and the control group was 12.53 ± 4.67 days and 11.45 ± 5.29 days, respectively(P>0.05).Except for one in control group died of severe gastrointestinal bleeding three weeks after the treatment, the levels of ALT, TBIL and DBIL in both group decreased significantly, and the condition improved considerablely as well (p < 0.05). The ALB levels in the both group were increased slightly within one week, while the ALB levels continued to increase following treatment in the both group(p < 0.001).(Fig. 3)
Complications
Procedure-related complications in the BBDC group were biliary hemorrhage, pancreatitis, cholangitis, and biliary re-intervention and the corresponding incidence were(3/34,8.82%), (1/34,2.94%), (2/34,5.88%), and (4/39,10.26%), while the incidence of control group were (2/39,5.12%), (2/39,5.12%), (1/39,2.56%) and (3/34,8.82% ), respectively(P>0.05).
Stent Patency, and Survival
During the follow-up, the incidence of hepatic failure, Multiple organ metastasis, Gastrointestinal bleeding, and Unknown death in BBDC group were (21/34, 61.76%), (9/34, 26.47%), (3/34, 8.82%),(1/34, 2.94%), respectively while the corresponding causes of death in the control group were (24/39, 61.53%), (8/39, 20.51%), (4/39, 10.25%), (3/39, 7.69%), respectively (p > 0.05)(Table 2).The patency was determined by clinical findings related to biliary obstruction, results of laboratory examination and / or subsequent reexamination by cholangiography or imaging. The median stent patency was 207 days (95% CI: 189.152, 224.848) in the BBDC group versus 180 days (95% CI: 170.367, 189.633) in the control group, and mean overall stent patency was 204.212 days (95% CI: 190.441, 217.983) in the BBDC group versus 186.278 months (95% CI: 173.427, 199.130) in the control group (p = 0.043, log-rank test).Additionally, the median overall survival was 245 days (95% CI: 232.010, 257.990) in the BBDC group versus 212 days (95% CI: 204.903, 219.097) in the control group, and mean overall survival was 244.883 days (95% CI: 230.414, 259.352) in the BBDC group versus 221.844 days (95% CI: 207.306, 236.383) in the control group (p = 0.030, log-rank test). (Fig. 4)
Table 2
Procedural details, post-procedure outcomes and follow-up data
Characteristics
|
Control group (n = 39)
|
BBDC group (n = 34)
|
P value
|
125I Seed number, (mean ± SD )
|
18.68 ± 2.99
|
38.84 ± 2.46
|
0.002‡
|
Cumulative dose at reference point
|
42.55 ± 2.60
|
85.14 ± 4.72
|
0.001‡
|
Hospital stay, day (mean ± SD)
|
11.45 ± 5.29
|
12.53 ± 4.67
|
0.596‡
|
Stent size (diameter × length)
|
|
|
0.463#
|
10 × 60 mm
|
27
|
20
|
|
10 × 50 mm
|
12
|
14
|
|
Complications
|
|
|
|
Biliary hemorrhage
|
2
|
3
|
0.695*
|
Pancreatitis
|
2
|
1
|
1.000*
|
Cholangitis
|
1
|
2
|
1.000*
|
Biliary re-intervention
|
4
|
3
|
1.000*
|
The reasons for death
|
|
|
|
Hepatic failure
|
24
|
21
|
0.984#
|
Multiple organ metastasis
|
8
|
9
|
0.589#
|
Gastrointestinal hemorrhage
|
4
|
3
|
1.000*
|
Unknown cause
|
3
|
1
|
0.618*
|
Follow-up anti-cancer treatments
|
|
|
|
Transarterial infusion chemotherapy
|
17
|
16
|
0.450#
|
Intravenous chemical therapy
|
14
|
12
|
1.000#
|
Immunotherapy
|
8
|
6
|
0.776#
|
*The Fisher exact test was used. |
#Pearson chi-square test was used. |
‡Difference in the variance between the two groups (Mann–Whitney test). |