Meta-Analysis
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©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. May 14, 2015; 21(18): 5719-5734
Published online May 14, 2015. doi: 10.3748/wjg.v21.i18.5719
Table 1 Definitions of clinical outcomes in each included study
Author Mortality Morbidity POPF Abdominal abscess Heslin et al [6 ] NA NA Drain output at a rate of ≥ 30 mL/d or more and lasting for more than 7 d Abdominal collection associated with fever and a positive culture requiring either percutaneous or operative drainage yielding positive cultures Conlon et al [8 ] Deaths within 30 d of surgery NA Drain output on postoperative day 5 or > 30 mL and amylase level > 150 IU/L and/or three times greater than the serum value Abdominal collection associated with fever and a positive culture requiring either surgical or radiologic drainage Fisher et al [7 ] Deaths within 30 d of surgery. CTCAE (v4.0)[35 ] ISGPF[36 ] Abdominal collection with a positive Gram stain or cultures Paulus et al [26 ] NA NA ISGPF[36 ] Abdominal collection associated with fever, abnormal blood routine test, and positive cultures Adham et al [29 ] Deaths within 90 d of surgery Clavien classification[37 ] ISGPF[36 ] Abdominal collection associated with fever and a positive culture requiring surgical drain or interventional treatment Correa-Gallego et al [9 ] Deaths within 90 d of surgery CTCAE (v4.0)[35 ] Clinical signs and symptoms with amylase-rich drainage > 50 mL/d beyond postoperative day 10 Clinical signs and symptoms or radiologic diagnosis of abdominal abscess or peritonitis Lim et al [27 ] Clavien classification[37 ] Clavien classification[37 ] ISGPF[36 ] NA Mehta et al [28 ] Deaths within 30 d of surgery Clavien classification[37 ] ISGPF[36 ] NA Van Buren et al [10 ] Deaths within 90 d of surgery CTCAE (v4.0)[35 ] ISGPF[36 ] NA
Table 2 Characteristics of included studies
Author, year Country Design No. of patients Group Age (yr) Male:female Operation type: No. of patients Heslin et al [6 ] United States OCS 89 Drain 65 ± 2 18:20 (58.1) PD: 51 1998 No drain 65 ± 2 32:19 PD: 38 Conlon et al [8 ] United States RCT 179 Drain 66 (23-81) 46:42 (49.7) PD: 73, DP: 15 2001 No drain 69 (33-87) 43:48 PD: 66, DP: 25 Fisher et al [7 ] United States OCS 228 Drain 63 (53-72) 78:101 (40.7) PD: 123, DP: 56 2011 No drain 59 (51-70) 19:40 PD: 30, DP: 17 Paulus et al [26 ] United States OCS 59 Drain 52 (44-66) NA DP: 39 2012 No drain 58 (52-68) NA DP: 30 Adham et al [29 ] France OCS 242 Drain 61.5 (20-85) 66:64 (52.4) PD: 79, DP: 29, Others: 22 2013 No drain 66.5 (19-85) 61:51 PD: 69, DP: 37, Others: 6 Correa-Gallego et al [9 ] United States OCS 739 (Subgroup A of PD) Drain NA NA PD: 386 2013 No drain NA NA PD: 353 350 (Subgroup B of DP) Drain NA NA DP: 154 No drain NA NA DP: 196 Lim et al [27 ] France OCS 54 Drain 62 (40-76) 8:19 (29.6) PD: 27 2013 No drain 62 (38-78) 8:19 PD: 27 Mehta et al [28 ] United States OCS 709 Drain 60 130:121 PD: 251 2013 No drain 62.5 232:236 PD: 458 Van Buren et al [10 ] United States RCT 137 Drain 62.1 ± 11.7 37:31 PD: 68 2013 No drain 64.3 ± 12.6 38:31 PD: 69
Table 3 Comparability between drained patients and non-drained patients
Author Comorbidity Preoperative treatment Preoperative biochemical test Pathology Length of operation Estimated blood loss Texture of pancreas Diameter of pancreatic duct Heslin et al [6 ] Comparable Comparable Comparable Comparable NA Comparable NA NA Conlon et al [8 ] NA Comparable NA Comparable Comparable Comparable NA NA Fisher et al [7 ] Significant difference NA Significant difference Comparable Comparable Significant difference Comparable Comparable Paulus et al [26 ] NA NA NA Comparable Comparable Comparable Comparable Adham et al [29 ] Comparable Comparable Comparable Comparable NA NA NA NA Correa-Gallego et al [9 ] PD subgroup NA Comparable NA Comparable Significant difference Significant difference Significant difference Comparable DP subgroup NA NA NA Comparable Significant difference Significant difference NA Significant difference Lim et al [27 ] Comparable Comparable Comparable Comparable Comparable Comparable Comparable Comparable Mehta et al [28 ] Comparable Comparable Comparable Comparable Significant difference Significant difference NA Significant difference Van Buren et al [10 ] Comparable Comparable Comparable Comparable Comparable Comparable Comparable Comparable
Table 4 Quality of assessment of included studies
Cohort studies Representativeness of the exposed cohort Selection of the non-exposed cohort Ascertainment of exposure Comparability between the two cohorts Assessment of outcome Length of follow-up Heslin et al [6 ] Potential selection bias Same patient base Surgical record No restriction/matching Independent assessment NM Paulus et al [26 ] Representative Same patient base Surgical record No restriction/matching Surgical record NM Fisher et al [7 ] Representative Different patient base Surgical record No restriction/matching Surgical record 30 d Adham et al [29 ] Representative Same patient base Surgical record No restriction/matching Surgical record 90 d Correa-Gallego et al [9 ] Representative Same patient base Surgical record No restriction/matching Surgical record 90 d Metha et al [28 ] Representative Same patient base Surgical record No restriction/matching Surgical record 90 d Case-control study Representativeness of the cases Selection of Controls Ascertainment of exposure Comparability of cases and controls Assessment of outcome Definition of Controls and cases Lim et al [27 ] Potential selection bias Hospital control Surgical record One to one matching Surgical record Surgical record RCTs Random sequence generation Allocation concealment Blinding of participants and personnel Blinding of outcome assessment Incomplete outcome data Selective reporting Conlon et al [8 ] Low risk Low risk High risk Low risk Unclear risk Low risk Van Buren et al [10 ] Low risk Low risk High risk Unclear risk Low risk Low risk
Table 5 Summary of results
Outcome of interest Studies Patients Results Pooled estimates P valueP value for HGI 2 No drainage Drainage No drainage Drainage (95%CI) Mortality Overall analysis 7 1353 1283 2.96% 1.87% 1.56 (0.93-2.62) 0.09 0.31 15% Restricted analysis of RCTs 2 160 150 6.25% 2.56% 2.55 (0.79-8.30) 0.12 0.25 26% Subgroup analysis of PD 5 954 911 3.35% 1.32% 2.39 (1.22-4.69) 0.01 0.52 0% Overall morbidity Overall analysis 9 1421 1373 43.54% 52.59% 0.69 (0.52-0.92) 0.01 0.01 58% Restricted analysis of RCTs 2 160 150 66.88% 67.31% 1.00 (0.58-1.72) 1.00 0.26 20% Subgroup analysis of PD 5 945 783 46.35% 51.34% 0.69 (0.56-0.84) < 0.01 0.23 28% Subgroup analysis of DP 2 226 193 27.88% 33.68% 1.29 (0.24-6.81) 0.76 < 0.01 89% POPF Overall analysis 7 1292 1234 13.78% 27.55% 0.55 (0.42-0.72) < 0.01 0.07 46% Subgroup analysis of PD 4 907 732 13.34% 26.23% 0.46 (0.35-0.59) < 0.01 0.24 28% Subgroup analysis of DP 2 226 193 16.81% 24.87% 0.39 (0.07-2.21) 0.29 0.17 46% CR-PF Overall analysis 6 743 694 9.02% 13.26% 0.72 (0.33-1.59) 0.42 < 0.01 69% Subgroup analysis of PD 3 554 346 8.84% 15.32% 0.61 (0.14-2.66) 0.51 < 0.01 81% Abdominal abscess Overall analysis 7 414 582 11.84% 8.59% 1.29 (0.84-1.98) 0.25 0.34 11% Restricted analysis of RCTs 2 160 150 15.00% 7.70% 1.95 (0.53-7.16) 0.32 0.09 65% Subgroup analysis of PD 3 134 146 14.18% 6.85% 2.12 (0.95-4.72) 0.07 0.13 50% Interventional radiology drainage Overall analysis 8 1309 1243 11.38% 12.31% 1.05 (0.69-1.62) 0.81 0.03 52% Restricted analysis of RCTs 2 160 150 14.38% 10.90% 1.35 (0.26-6.97) 0.72 0.02 81% Subgroup analysis of PD 5 945 783 10.16% 12.52% 0.87 (0.65-1.19) 0.39 0.13 43% Subgroup analysis of DP 2 226 193 18.14% 20.73% 1.03 (0.38-2.80) 0.95 0.13 57% Reoperation Overall analysis 9 1421 1373 4.71% 4.73% 1.01 (0.70-1.47) 0.95 0.59 0% Restricted analysis of RCTs 2 160 150 16.67% 6.41% 1.11 (0.17-7.29) 0.91 0.07 70% Subgroup analysis of PD 5 945 783 4.02% 2.68% 1.26 (0.73-2.17) 0.41 0.51 0% Subgroup analysis of DP 2 226 193 3.54% 6.22% 0.80 (0.29-2.17) 0.66 0.46 0% Length of hospital stay Overall analysis 9 1421 1373 - - -0.96 [-1.74-(-0.18)] 0.02 < 0.01 92% Restricted analysis of RCTs 2 160 150 - - 0.78 (-0.40-1.97) 0.19 0.49 0% Subgroup analysis of PD 5 945 783 - - -0.75 (-1.73-0.24) 0.14 < 0.01 85% Subgroup analysis of DP 2 226 193 - - -2.10 [-2.46-(-1.73)] < 0.01 0.29 11%