A total of 290 consecutive patients with malignant obstructive jaundice who underwent a radical resection at Zhongshan Hospital between June 2017 and December 2019 were included in the study. One hundred fifty-nine (54.8%) patients received PBD (group PG) before the resection, and 131 (45.2%) patients underwent a radical resection directly after admission (group DG). In group PG, for 5 (3.1%), 5 (3.1%), and 149 (93.7%) out of 159 patients, EBS, ENBD, and PTBD were chosen as initial PBD, respectively. Eight patients (5.0% of the 159) needed a second PBD, which was PTBD in all cases. The frequency of the second PBD was not significantly different among the 3 subgroups (P = 0.082; Table 1). Radical resections included pancreaticoduodenectomy, radical resection for pCCA, and other procedures according to the tumor site.
Table 1
The frequency of a second PBD in group PG
| Total | EBS | ENBD | PTBD | Statistic | P value |
First PBD | 159 (100%) | 5 (3.1%) | 5 (3.1%) | 149 (93.7%) | χ2 = 5.665 | 0.082* |
Second PBD | 8 (5.0%) | 1 (20.0%) | 1 (20.0%) | 6 (4.0%) |
*Fisher’s exact test in Monte Carlo mode. |
Patient Characteristics
Baseline characteristics of the patients with malignant obstructive jaundice in groups DG and PG are described in Table 2. The baseline characteristics (on admission) including age, sex, and BMI were not significantly different between the two groups. ASA scores were significantly different between the two groups: the PG group contained more patients with ASA score III–IV (P < 0.001). One hundred seventy-two (59.1%) patients had proximal biliary obstruction, and 119 (40.9%) distal biliary obstruction. The site of obstruction did not significantly affect the choice of PBD (P = 0.301). Final histopathological diagnoses were as follows: 4 iCCAs and 14 GBCs with invasion of an extrahepatic bile duct, 153 pCCAs, 51 distal biliary carcinomas, 47 ampullary carcinomas, 20 PDACs, and 1 hepatocellular carcinoma with invasion of an extrahepatic bile duct; prevalence rates of these diagnoses were not significantly different between groups DG and PG (P = 0.301).
Table 2
Demographic data on the patients under study
Characteristics | Total (n=290) | DG (n=131) | PG (n=159) | statistic | P value |
Age (years) | Mean±SD (range) | 62.21±9.41 (24-80) | 62.21±9.60 (24-80) | 62.2±9.30 (28-80) | t=0.007 | 0.994 |
≥70, n (%) | 63 (21.72%) | 29 (22.14%) | 34 (21.38%) | χ2= 0.024 | 0.877 |
<70, n (%) | 227 (78.28%) | 102 (77.86%) | 125 (78.62%) |
Sex | Male, n (%) | 185 (63.79%) | 82 (62.60%) | 103 (64.78%) | χ2= 0.148 | 0.700 |
Female, n (%) | 105 (36.21%) | 49 (37.40%) | 56 (35.22%) |
BMI (kg/m2) | Mean±SD | 22.72±3.02 | 22.52±2.65 | 22.86±3.25 | t=0.862 | 0.389 |
ASA score | I | 22 (7.59%) | 10 (7.63%) | 12 (7.55%) | χ2= 17.810 | <0.001 |
II | 237 (81.72%) | 118 (90.08%) | 119 (74.84%) |
III-IV | 31 (10.69%) | 3 (2.29%) | 28 (17.61%) |
Medical history | hepatolithiasis | 12 | 2 | 10 | χ2= 1.752 | 0.636* |
cholecystolithiasis | 29 | 11 | 18 |
HBP | 50 | 17 | 33 |
Diabetes | 26 | 8 | 18 |
Obstruc- Tion site | Proximal | 172 | 82 | 90 | χ2= 1.068 | 0.301 |
Distal | 118 | 49 | 69 |
Histopa- thological diagnosis | iCCA | 4 | 3 | 1 | χ2= 4.187 | 0.664* |
GBC | 14 | 8 | 6 |
pCCA | 153 | 71 | 82 |
biliary carcinoma | 51 | 21 | 30 |
ampullary carcinoma | 47 | 21 | 26 |
PDAC | 20 | 7 | 13 |
hepatocellular carcinoma | 1 | 0 | 1 |
*Fisher’s exact test in Monte Carlo mode. |
HBP: high blood pressure. |
Laboratory Testing Results
A comparison of these data between the time of initial diagnosis and the time point of perioperative testing is presented in Table 3. Within the DG group, initial laboratory test results including hemoglobin (Hb) and ALB (albumin) were significantly higher as compared with the perioperative test (P < 0.001 and P = 0.016). ALT and AST levels also decreased significantly (P < 0.001 and P = 0.005, respectively). TB and direct bilirubin (DB) levels increased obviously (both P < 0.001). PBD was found to prevent the deterioration of liver function. Within the PG group, Hb levels improved significantly (P < 0.001). ALT, AST, TB, and DB decreased significantly (P < 0.001, P < 0.001, P < 0.001, and P < 0.001, respectively).
Table 3
A comparison of laboratory testing results between two time points (initial diagnosis and perioperative testing) within each group
Parameters | DG | Within DG | PG | Within PG |
initial | perioperative | cases with paired data available | statistic | P value | initial | perioperative | cases with paired data available | statistic | P value |
Hb (g/L) | 126.13±14.34 | 122.97±14.71 | 124 | t=5.400 | <0.001 | 121.47±17.51 | 114.70±15.78 | 147 | t=6.352 | <0.001 |
WBC (10^9/L) | 6.12±1.84 | 5.98±1.75 | 124 | t=1.463 | 0.146 | 6.45±2.10 | 6.34±2.00 | 147 | t=0.639 | 0.524 |
NEUT (%) | 63.10±9.36 | 64.23±9.31 | 124 | t=-1.789 | 0.076 | 66.94±9.27 | 62.30±9.37 | 146 | t=4,705 | 0.028 |
Plt (10^9/L) | 252.23±83.36 | 254.86±85.68 | 124 | t=-0.751 | 0.454 | 253.24±87.03 | 243.80±83.14 | 147 | t=1.764 | <0.001 |
ALB (g/L) | 38.82±4.09 | 38.17±4.05 | 121 | t=2.435 | 0.016 | 37.43±4.99 | 40.70±5.22 | 147 | t=-5.914 | 0.100 |
ALT (U/L) | 200.21±151.89 | 165.80±140.32 | 122 | t=4.517 | <0.001 | 166.09±152.17 | 78.52±59.40 | 147 | t=7.656 | <0.001 |
AST (U/L) | 133.94±99.47 | 115.38±93.63 | 122 | t=2.887 | 0.005 | 131.58±122.80 | 54.60±43.18 | 146 | t=7.882 | 0.001 |
TB (µmol/L) | 140.99±83.27 | 158.12±95.11 | 122 | t=-4.572 | <0.001 | 227.38±126.49 | 83.03±57.59 | 147 | t=14.399 | <0.001 |
DB (µmol/L) | 116.11±70.21 | 133.40±79.21 | 121 | t=-5.402 | <0.001 | 186.06±103.03 | 71.49±49.17 | 147 | t=13.904 | <0.001 |
GGT (U/L) | 798.17±602.69 | 739.93±593.06 | 119 | t=3.228 | 0.002 | 586.88±436.73 | 228.60±181.69 | 145 | t=11.031 | <0.001 |
ALP (U/L) | 434.24±268.60 | 423.75±262.36 | 122 | t=1.031 | 0.305 | 465.28±363.83 | 230.40±158.91 | 145 | t=9.484 | <0.001 |
Na (mmol/L) | 139.83±3.01 | 139.74±3.16 | 119 | t=0.460 | 0.646 | 138.87±3.16 | 139.78±2.96 | 146 | t=-3.279 | <0.001 |
PT (s) | 11.35±1.42 | 11.20±1.22 | 117 | t=0.843 | 0.401 | 11.59±1.51 | 11.65±1.08 | 146 | t=-0.402 | 0.682 |
Hb: hemoglobin; WBC: white blood cell; NEUT: neutrophils; Plt: platelet; ALB: albumin; ALT: alanine transminase-glutamic pyruvic transaminase; AST: aspartate transminase-glutamic oxalo-acetic transaminase; TB: total bilirubin; DB: direct bilirubin; GGT: γ-glutamyltransferase; ALP: alkaline phosphatase; Na; natrium; PT: prothrombin time |
A comparison of the laboratory test results between the two groups is presented in Table 4. At the time of initial diagnosis, the PG patients had severer anemia, higher percentage of neutrophils (NEUT %), hypoalbuminemia, and jaundice (P = 0.015, P = 0.001, P = 0.038, and P < 0.001, respectively). As to perioperative laboratory findings, the PG patients’ condition reversed in terms of neutrophils, hypoalbuminemia and jaundice (P = 0.050, < 0.001, and < 0.001, respectively), but their anemia did not improve (P < 0.001).
Table 4
A comparison of laboratory testing results at two time points (initial diagnosis and perioperative testing) between the two groups
Characteristics | DG | PG | Initial data compared between groups | Perioperative data compared between groups |
| initial | perioperative | initial | perioperative | statistic | P value | statistic | P value |
Hb (g/L) | 125.85±14.41 | 123.11±14.74 | 121.17±17.58 | 115.35±15.93 | t=2.441 | 0.015 | t=4.193 | <0.001 |
WBC (109/L) | 6.11±1.82 | 6.00±1.76 | 6.55±2.26 | 6.37±2.04 | t=-1.754 | 0.081 | t=-1.670 | 0.096 |
NEUT (%) | 63.15±9.44 | 64.16±9.31 | 67.11±9.40 | 61.9±9.51 | t=-3.504 | 0.001 | t=1.972 | 0.050 |
Plt (109/L) | 250.5±82.90 | 255.24±85.44 | 255.6±88.94 | 248.31±84.76 | t=-0.494 | 0.662 | t=0.679 | 0.498 |
ALB (g/L) | 38.57±4.16 | 38.21±4.06 | 37.42±4.96 | 40.75±5.23 | t=2.085 | 0.038 | t=-4.552 | <0.001 |
ALT (U/L) | 198.78±153.36 | 165.80±140.32 | 166.10±150.58 | 79.19±62.58 | t=1.799 | 0.073 | t=6.340 | <0.001 |
AST (U/L) | 134.50±99.18 | 115.38±93.63 | 131.63±121.91 | 55.24±44.08 | t=0.140 | 0.889 | t=6.530 | <0.001 |
TB (µmol/L) | 140.84±82.94 | 158.12±95.11 | 225.1±126.27 | 81.76±56.74 | t=-6.695 | <0.001 | t=7.837 | <0.001 |
DB (µmol/L) | 115.70±69.55 | 132.52±79.48 | 184.20±102.96 | 70.36±48.47 | t=-6.601 | <0.001 | t=7.598 | <0.001 |
GGT (U/L) | 812.81±627.21 | 736.18±592.00 | 582.53±434.59 | 224.00±178.62 | t=3.501 | 0.001 | t=9.160 | <0.001 |
ALP (U/L) | 430.06±265.00 | 423.75±262.36 | 465.36±362.82 | 230.09±157.57 | t=-0.936 | 0.350 | t=7.195 | <0.001 |
Na (mmol/L) | 139.74±3.03 | 139.75±3.15 | 138.88±3.18 | 139.87±2.96 | t=2.303 | 0.022 | t=-0.327 | 0.728 |
PT (s) | 11.53±2.12 | 11.16±1.21 | 11.569±1.50 | 11.69±1.09 | t=-0.171 | 0.864 | t=-3.824 | <0.001 |
All Postoperative Outcomes And Risk Factors For Postoperative Complications
The postoperative outcomes are shown in Table 5. The overall rate of postoperative complications was 46.4% (134 patients out of 290), and complications occurred more frequently in group DG (P = 0.029). The postoperative hemorrhage rate was significantly higher in group DG (P = 0.038), whereas postoperative delayed gastric emptying was significantly more frequent in group PG (P = 0.065). The rates of mortality and of other complications were similar between the two groups. The location of obstruction was used to decide on the main routine surgical procedure, and each group was divided into a proximal-obstruction subgroup and distal-obstruction subgroup. The overall rate of postoperative complications in the combined proximal-obstruction group was 77.9% (Table 6), and complications occurred more frequently in the proximal-obstruction DG subgroup (P = 0.038; Table 7). In the combined distal-obstruction group, the overall rate of postoperative complications was 50.8% (Table 6), and PBD did not affect this rate (P = 0.249, Table 7).
Table 5
All postoperative complications in the study population
| Total (n=290) | DG (n=131) | PG (n=159) | statistic | P value |
All complications | 134 | 70 | 64 | χ2 = 5.002 | 0.025 |
Intestinal fistula | 23 | 10 | 13 | χ2 = 0.029 | 0.865 |
Pancreatic fistula | 20 | 10 | 10 | χ2 = 0.202 | 0.653 |
Biliary fistula | 1 | 0 | 1 | - | - |
Gastrointestinal anastomotic fistula | 2 | 0 | 2 | - | - |
Abdominal liquid accumulation | 31 | 16 | 15 | χ2 = 0.581 | 0.446 |
Delayed gastric emptying | 17 | 4 | 13 | χ2 = 3.415 | 0.065 |
Hemorrhage | 21 | 14 | 7 | χ2 = 4.223 | 0.040 |
Hepatic failure | 6 | 3 | 3 | - | 1.000 |
Reoperation | 11 | 6 | 5 | χ2 = 0.406 | 0.552 |
Incision complication | 8 | 3 | 5 | χ2 = 0.196 | 0.733 |
Mortality | 6 | 3 | 3 | - | 1.000 |
Sepsis | 78 | 41 | 37 | χ2 = 2.354 | 0.125 |
Table 6
Postoperative outcomes in proximal- and distal-obstruction groups
| Proximal obstruction | Distal obstruction | statistic | P value |
Total | 172 | 118 | χ2 = 23.141 | <0.001 |
All complications (%) | 134 (77.9%) | 60 (50.8%) |
Table 7
Postoperative outcomes by subgroups
| Total | DG | PG | statistic | P value |
Proximal obstruction (number of patients) | 172 | 82 | 90 | χ2 = 4.295 | 0.038 |
Complication(s) (number of patients) | 134 | 70 | 64 |
Distal obstruction | 118 | 49 | 69 | χ2 = 1.329 | 0.249 |
Complication(s) | 60 | 28 | 32 |
In univariate analysis, PBD proved to be associated with better postoperative outcomes (P = 0.025; Table 8). Perioperative Hb and perioperative TB were associated with postoperative complications (P = 0.027 and P = 0.016, respectively). Multivariate analysis indicated that perioperative TB is an independent risk factor for postoperative complications (Table 8).
Table 8
Univariate and multivariate analyses of factors possibly associated with postoperative outcomes in the study population (290 patients)
| Univariate analysis | Multivariate analysis |
| HR | 95% CI | P value | HR | 95% CI | P value |
Age>70 | 0.831 | 0.456-1.515 | 0.545 | | | |
Gender | 0.971 | 0.601-1.570 | 0.906 | | | |
Tumor site | 0.970 | 0.606-1.553 | 0.900 | | | |
PBD | 0.587 | 0.368-0.937 | 0.025 | | | 0.163 |
Initial Hb | 1.012 | 0.997-1.027 | 0.111 | | | |
Perioperative Hb | 1.017 | 1.002-1.033 | 0.027 | | | 0.059 |
Initial WBC | 0.953 | 0.849-1.068 | 0.407 | | | |
Perioperative WBC | 1.006 | 0.891-1.137 | 0.922 | | | |
Initial TB | 0.999 | 0.997-1.001 | 0.516 | | | |
Perioperative TB | 1.004 | 1.001-1.007 | 0.016 | 1.004 | 1.001-1.007 | 0.017 |
Initial GGT | 1.000 | 1.000-1.000 | 0.860 | | | |
Perioperative GGT | 1.000 | 1.000-1.001 | 0.893 | | | |
Initial Na | 0.936 | 0.867-1.011 | 0.091 | | | 0.184 |
Perioperative Na | 0.990 | 0.916-1.071 | 0.806 | | | |
Initial PT | 0.962 | 0.841-1.100 | 0.567 | | | |
Perioperative PT | 0.915 | 0.746-1.123 | 0.395 | | | |
HR: hazard ratio, CI: confidence interval, GGT: gamma-glutamyl transferase. |
Preoperative TB concentration greater than 162 µmol/L distinguished patients with postoperative complication(s) from those without (Fig. 1, ROC curve analysis). For this cutoff, the area under the ROC curve was 0.7024 (95% confidence interval 0.588–0.816) (P = 0.002, sensitivity 62.8%, specificity 74.4%).