Demographic and Clinical characteristics
A total of 164 consecutive patients were included in the study. The demographic data and clinical characteristics of the two groups are shown in Table 1. There was no statistical difference in average age (PBD 61.8 ± 10.6, DS 61.9 ± 8.8, P = 0.94), gender (108 males, 58 females, P = 0.56), comorbity (hypertension 22.7% in PBD group, 24.2% in DS group, P = 0.848; diabetes 18.2% in PBD group, 16.7% in DS group, P = 0.819). The total bilirubin (TB) before surgery in PBD group was significantly lower than that in DS group(PBD 125.9 ± 109.5umol/L,DS 250.6 ± 124.1umol/L༌P = 0.001)。
Table 1
Demographic and clinical characteristics
|
|
PBD
(n = 44)
|
DS
(n = 120)
|
P
|
Age, years
|
|
61.8 ± 10.6
|
61.9 ± 8.8
|
0.94
|
Gender
|
male
|
30(68.2)
|
76(63.3)
|
0.56
|
|
female
|
14(31.8)
|
44(36.7)
|
|
BMI
|
|
22.4 ± 2.7
|
22.4 ± 3.5
|
0.9
|
Smoking history
|
yes
|
29(65.9)
|
87(72.5)
|
0.41
|
|
no
|
15(34.1)
|
33(27.5)
|
|
Drinking history
|
yes
|
28(63.6)
|
77(64.2)
|
0.95
|
|
no
|
16(36.4)
|
43(35.8)
|
|
ASA score
|
≤ 2
|
35(79.5)
|
103(85.8
|
0.32
|
|
3
|
9(20.5)
|
17(14.2)
|
|
hypertension
|
yes
|
10(22.7)
|
29(24.2)
|
0.848
|
|
no
|
34(77.3)
|
91(75.8)
|
|
diabetes
|
yes
|
8(18.2)
|
20(16.7)
|
0.819
|
|
no
|
36(71.8)
|
100(83.3)
|
|
TB, umol / L
|
|
125.9 ± 109.5
|
250.6 ± 124.1
|
0.001
|
ALB, U/L
|
|
39.4 ± 4.5
|
38.4 ± 3.6
|
0.128
|
ALT, U/L
|
|
77.8 ± 53.1
|
197.8 ± 124.7
|
0.001
|
AST, U/L
|
|
53.5 ± 27.5
|
129.9 ± 113.6
|
0.001
|
BMI, body mass index; ASA, American Society of Anesthesiologists; TB, total bilirubin; ALB, albumin; ALT, alanine Aminotransferase; AST, aspartate aminotransferase |
Surgical outcomes
The operation-related data are shown in Table 2. The operation methods were divided into standard PD and PPPD. PD was performed in 84.1% of PBD group, and that of DS group was 85.8%. There was no significant difference between the two groups (P = 0.9087). The softness of pancreatic texture is an important factor causing postoperative pancreatic fistula. The ratio of soft pancreatic texture of the two groups were 86.4% and 85.8%, respectively, without significant difference (P = 0.931). There was no significant difference in vascular resection rate between the two groups (PBD 13.6%, DS 26.7%, P = 0.08). In addition, there was no significant difference in operation time (PBD 187 ± 68.8 min, DS 187 ± 68.8 min, P = 0.309) and intraoperative blood loss (PBD 485 ± 443 ml, DS 485 ± 443 ml, P = 0.858) between this two groups.
Table 2
|
|
PBD
(n = 44)
|
DS
(n = 120)
|
P
|
Operation type
|
PPPD
|
7(15.9)
|
20(16.7)
|
0.908
|
|
PD
|
37(84.1)
|
100(83.3)
|
|
Pancreatic texture
|
soft
|
38(86.4)
|
103(85.8)
|
0.931
|
|
hard
|
6(13.6)
|
17(14.2)
|
|
Diameter of pancreatic duct, mm
|
≤ 2
|
3.75 ± 1.2
|
3.87 ± 1.3
|
0.599
|
|
> 2
|
|
|
|
Vascular invasion
|
yes
|
10(22.7)
|
44(36.7)
|
0.092
|
|
no
|
34(77.3)
|
76(63.3)
|
|
Vascular resection
|
yes
|
6(13.6)
|
32(26.7)
|
0.08
|
|
no
|
38(86.4)
|
88(73.3)
|
|
Operation time
|
|
187.±68.8
|
177.9 ± 47.7
|
0.309
|
Intraoperative blood loss, ml
|
|
485 ± 443
|
501 ± 528
|
0.858
|
Postoperative outcomes
The comparison of postoperative complications is shown in Table 3. The incidence of overall morbidity in PBD group was 54.5%, and major complications 20.5%. DS group was 61.7% and 11.7% respectively, in the meanwhile. There was no significant difference in the overall morbidity and severe complications between the two groups (P = 0.41, 0.151, respectively). The incidence of POPF was 31.8% in PBD group and 26.7% in DS group, with no significant difference (P = 0.515). There was no significant difference in PPH (PBD 25%, DS 17.5%, P = 0.283), IAA (PBD 36.4, DS 34.2%, P = 0.793), sepsis (PBD 11.4%, DS 6.7%, P = 0.509), postoperative hospital stay (PBD 19.5 days, DS 18.2 days, P = 0.534) and 90-day death (PBD 6.8%, DS 3.3%, P = 0.588). The incidence of DGE in PBD group was significantly lower than that in DS group PBD 4.5%, DS 19.2% (P = 0.021).
Table 3
|
|
PBD
(n = 44)
|
DS
(n = 120)
|
P
|
Overall morbidity
|
yes
|
24(54.5)
|
74(61.7)
|
0.41
|
|
no
|
20(45.5)
|
46(38.3)
|
|
CD score
|
gradeⅠ-Ⅱ
|
35(79.5)
|
106(88.3)
|
0.151
|
|
≥Grade Ⅲ
|
9(20.5)
|
14(11.7)
|
|
POPF
|
yes
|
14(31.8)
|
32(26.7)
|
0.515
|
|
no
|
30(68.2)
|
88(73.3)
|
|
PPH
|
yes
|
11(25)
|
21(17.5)
|
0.283
|
|
no
|
33(75)
|
99(82.5)
|
|
IAA
|
yes
|
16(36.4)
|
41(34.2)
|
0.793
|
|
no
|
28(63.6)
|
79(65.8)
|
|
Sepsis
|
yes
|
5(11.4)
|
8(6.7)
|
0.509
|
|
no
|
39(88.6)
|
112(93.3)
|
|
DGE
|
yes
|
2(4.5)
|
23(19.2)
|
0.021
|
|
no
|
42(95.5)
|
97(80.8)
|
|
Postoperative hospital stay, days
|
|
19.5 ± 14.5
|
18.2 ± 9.8
|
0.534
|
90-day death
|
yes
|
3(6.8)
|
4(3.3)
|
0.588
|
|
no
|
41(93.2)
|
116(96.7)
|
|
POPF, postoperative pancreatic fistula; PPH, postpancreatectomy hemorrhage; IAA, intra-abdominal abscess; DGE, delayed gastric emptying |
Multivariate regression analysis
Univariate analysis showed that age over 66 years (P = 0.013) and direct surgery (P = 0.021) were associated with postoperative DGE. In the multivariate logistic regression analysis, age over 66 years (OR: 3.094, 95% CI: 1.268–7.55) and direct surgery (OR: 5.298, 95% CI: 1.176–23.865) were independent risk factors of DGE(Table 4).
Table 4
Multivariate regression analysis of risk factors for DGE
Variable
|
group
|
univariate
|
multivariate
|
|
|
N
|
P
|
OR(95%CI)
|
P
|
age, years
|
< 66
|
10(9.8)
|
0.013
|
3.094(1.268–7.55)
|
0.013
|
|
≥ 66
|
15(24.2)
|
|
|
|
Sex
|
male
|
16(15.1)
|
0.943
|
|
|
|
female
|
9(15.5)
|
|
|
|
BMI
|
< 18.5
|
2(18.2)
|
0.418
|
|
|
|
18.5–24.9
|
16(12.8)
|
|
|
|
|
25-29.9
|
6(26.1)
|
|
|
|
|
≧ 30
|
1(20)
|
|
|
|
Smoking
|
Yes
|
8(16.7)
|
0.744
|
|
|
|
no
|
17(14.7)
|
|
|
|
ECOG score
|
≤ 1
|
14(13.7)
|
0.488
|
|
|
|
> 1
|
11(17.7)
|
|
|
|
ASA score
|
≤ 2
|
21(15.2)
|
1
|
|
|
|
3
|
4(15.4)
|
|
|
|
Hypertension
|
yes
|
8(20.5)
|
0.294
|
|
|
|
no
|
17(13.6)
|
|
|
|
Diabetes
|
Yes
|
6(21.4)
|
0.477
|
|
|
|
no
|
19(14)
|
|
|
|
PBD status
|
no
|
23(19.2)
|
|
5.298(1.176–23.865)
|
0.03
|
|
Yes
|
2(4.5)
|
|
|
|
Operation type
|
PPPD
|
1(3.7)
|
0.125
|
|
|
|
PD
|
24(17.5)
|
|
|
|
Operation time, min
|
< 180
|
12(14.5)
|
0.777
|
|
|
|
≥ 180
|
13(16)
|
|
|
|
Intraoperative blood loss, ml
|
< 400
|
13(16)
|
0.777
|
|
|
≥ 400
|
12(14.5)
|
|
|
|