Skip to main content
Top
Published in: Annals of Surgical Oncology 5/2024

Open Access 24-02-2024 | Relaparotomy | Pancreatic Tumors

Early Versus Late Drainage Removal in Patients Who Underwent Pancreaticoduodenectomy: A Comprehensive Systematic Review and Meta-analysis of Randomized Controlled Trials Using Trial Sequential Analysis

Authors: Claudio Ricci, MD, PhD, Davide Giovanni Grego, MD, Laura Alberici, MD, Carlo Ingaldi, MD, PhD, Stefano Togni, MD, Ermenegilda De Dona, MD, Riccardo Casadei, MD

Published in: Annals of Surgical Oncology | Issue 5/2024

Login to get access

Abstract

Background

The superiority of early drain removal (EDR) versus late (LDR) after pancreaticoduodenectomy (PD) has been demonstrated only in RCTs.

Methods

A meta-analysis was conducted using a random-effects model and trial sequential analysis. The critical endpoints were morbidity, redrainage, relaparotomy, and postoperative pancreatic fistula (CR-POPF). Hemorrhage (PPH), delayed gastric emptying (DGE), length of stay (LOS), and readmission rates were also evaluated. Risk ratios (RRs) and mean differences (MDs) with a 95% confidence interval (CI) were calculated. Type I and type II errors were excluded, comparing the accrued sample size (ASS) with the required sample size (RIS). When RIS is superior to ASS, type I or II errors can be hypothesized.

Results

ASS was 632 for all endpoints except DGE and PPH (557 patients). The major morbidity (RR 0.55; 95% CI 0.32–0.97) was lower in the EDR group. The CR-POPF rate was lower in the EDR than in the LDR group (RR 0.50), but this difference is not statistically significant (95% CI 0.24–1.03). The RIS to confirm or exclude these results can be reached by randomizing 5959 patients. The need for percutaneous drainage, relaparotomy, PPH, DGE, and readmission rates was similar. The related RISs were higher than ASS, and type II errors cannot be excluded. LOS was shorter in the EDR than the LDR group (MD − 2.25; 95% CI − 3.23 to − 1.28). The RIS was 567, and type I errors can be excluded.

Conclusions

EDR, compared with LDR, is associated with lower major morbidity and shorter LOS.
Appendix
Available only for authorised users
Literature
1.
go back to reference Strobel O, Neoptolemos J, Jӓger D, Büchler MW. Optimizing the outcomes of pancreatic cancer surgery. Nat Rev Clin Oncol. 2019;16:11–26.CrossRefPubMed Strobel O, Neoptolemos J, Jӓger D, Büchler MW. Optimizing the outcomes of pancreatic cancer surgery. Nat Rev Clin Oncol. 2019;16:11–26.CrossRefPubMed
2.
go back to reference Bassi C, Marchegiani G, Dervenis C, et al. The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 years after. Surgery. 2017;161:584–91.CrossRefPubMed Bassi C, Marchegiani G, Dervenis C, et al. The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 years after. Surgery. 2017;161:584–91.CrossRefPubMed
3.
go back to reference Wente MN, Veit JA, Bassi C, et al. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007;142:20–5.CrossRefPubMed Wente MN, Veit JA, Bassi C, et al. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007;142:20–5.CrossRefPubMed
4.
go back to reference Gustafsson UO, Scott MJ, Hubner M, et al. Guidelines for perioperative care in elective colorectal surgery: Enhanced Recovery After Surgery (ERAS®) Society recommendations: 2018. World J Surg. 2019;43:659–95.CrossRefPubMed Gustafsson UO, Scott MJ, Hubner M, et al. Guidelines for perioperative care in elective colorectal surgery: Enhanced Recovery After Surgery (ERAS®) Society recommendations: 2018. World J Surg. 2019;43:659–95.CrossRefPubMed
5.
go back to reference Joliat GR, Kobayashi K, Hasegawa K, et al. Guidelines for perioperative care for liver surgery: Enhanced Recovery After Surgery (ERAS) Society recommendations 2022. World J Surg. 2023;47:11–34.CrossRefPubMed Joliat GR, Kobayashi K, Hasegawa K, et al. Guidelines for perioperative care for liver surgery: Enhanced Recovery After Surgery (ERAS) Society recommendations 2022. World J Surg. 2023;47:11–34.CrossRefPubMed
6.
go back to reference van Santvoort HC. Postoperative pancreatic fistula: focus should be shifted from early drain removal to early management. B J Surg Open. 2023;6(7):zrac156. van Santvoort HC. Postoperative pancreatic fistula: focus should be shifted from early drain removal to early management. B J Surg Open. 2023;6(7):zrac156.
7.
go back to reference Kawai M, Tani M, Terasawa H, et al. Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients. Ann Surg. 2006;244:1–7.CrossRefPubMedPubMedCentral Kawai M, Tani M, Terasawa H, et al. Early removal of prophylactic drains reduces the risk of intra-abdominal infections in patients with pancreatic head resection: prospective study for 104 consecutive patients. Ann Surg. 2006;244:1–7.CrossRefPubMedPubMedCentral
8.
go back to reference Li T, Zhang J, Zeng J, et al. Early drain removal and late drain removal in patients after pancreatoduodenectomy: a systematic review and meta-analysis. Asian J Surg. 2022;S1015–9584(22):01305–7. Li T, Zhang J, Zeng J, et al. Early drain removal and late drain removal in patients after pancreatoduodenectomy: a systematic review and meta-analysis. Asian J Surg. 2022;S1015–9584(22):01305–7.
9.
go back to reference Claire R, Gluud C, Berlin I, et al. Using trial sequential analysis for estimating the sample sizes of further trials: example using smoking cessation intervention. BMC Med Res Methodol. 2020;20:284.CrossRefPubMedPubMedCentral Claire R, Gluud C, Berlin I, et al. Using trial sequential analysis for estimating the sample sizes of further trials: example using smoking cessation intervention. BMC Med Res Methodol. 2020;20:284.CrossRefPubMedPubMedCentral
10.
go back to reference Wetterslev J, Thorlund K, Brok J, et al. Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. J Clin Epidemiol. 2008;61:64–75.CrossRefPubMed Wetterslev J, Thorlund K, Brok J, et al. Trial sequential analysis may establish when firm evidence is reached in cumulative meta-analysis. J Clin Epidemiol. 2008;61:64–75.CrossRefPubMed
11.
go back to reference Kang H. Trial sequential analysis: novel approach for meta-analysis. Anesth Pain Med (Seoul). 2021;16:138–50.CrossRefPubMed Kang H. Trial sequential analysis: novel approach for meta-analysis. Anesth Pain Med (Seoul). 2021;16:138–50.CrossRefPubMed
13.
go back to reference Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. B Med J. 2009;339:b2700.CrossRef Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. B Med J. 2009;339:b2700.CrossRef
14.
go back to reference Eriksen MB, Frandsen TF. The impact of patient, intervention, comparison, outcome (PICO) as a search strategy tool on literature search quality: a systematic review. J Med Libr Assoc. 2018;106:420–1.CrossRefPubMedPubMedCentral Eriksen MB, Frandsen TF. The impact of patient, intervention, comparison, outcome (PICO) as a search strategy tool on literature search quality: a systematic review. J Med Libr Assoc. 2018;106:420–1.CrossRefPubMedPubMedCentral
15.
go back to reference Lark J, Glasziou P, Del Mar C, Bannach-Brown A, Stehlik P, Scott AM. A full systematic review was completed in 2 weeks using automation tools: a case study. J Clin Epidemiol. 2020;2020(121):81–90. Lark J, Glasziou P, Del Mar C, Bannach-Brown A, Stehlik P, Scott AM. A full systematic review was completed in 2 weeks using automation tools: a case study. J Clin Epidemiol. 2020;2020(121):81–90.
16.
go back to reference Guyatt GH, Oxman AD, Vist GE, GRADE Working Group, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. B Med J. 2008;336:924–6.CrossRef Guyatt GH, Oxman AD, Vist GE, GRADE Working Group, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. B Med J. 2008;336:924–6.CrossRef
17.
go back to reference Casadei R, Ricci C, Pezzilli R, et al. Usefulness of the Clavien-Dindo classification after pancreaticoduodenectomy. ANZ J Surg. 2011;81:747–8.CrossRefPubMed Casadei R, Ricci C, Pezzilli R, et al. Usefulness of the Clavien-Dindo classification after pancreaticoduodenectomy. ANZ J Surg. 2011;81:747–8.CrossRefPubMed
18.
go back to reference Wente MN, Bassi C, Dervenis C, et al. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007;142:761–8.CrossRefPubMed Wente MN, Bassi C, Dervenis C, et al. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007;142:761–8.CrossRefPubMed
19.
go back to reference Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. B Med J. (in press) Sterne JAC, Savović J, Page MJ, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. B Med J. (in press)
20.
go back to reference Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol. 2005;5:135.CrossRef Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol. 2005;5:135.CrossRef
21.
go back to reference Wan X, Wang W, Liu J, et al. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014;14(135):982–9. Wan X, Wang W, Liu J, et al. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014;14(135):982–9.
22.
go back to reference Moseley AM, Elkins MR, Herbert RD, et al. Cochrane reviews used more rigorous methods than non-Cochrane reviews: survey of systematic reviews in physiotherapy. J Clin Epidemiol. 2009;62:1021–30.CrossRefPubMed Moseley AM, Elkins MR, Herbert RD, et al. Cochrane reviews used more rigorous methods than non-Cochrane reviews: survey of systematic reviews in physiotherapy. J Clin Epidemiol. 2009;62:1021–30.CrossRefPubMed
23.
go back to reference Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst. 1959;22:719–48.PubMed Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst. 1959;22:719–48.PubMed
24.
go back to reference Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21:1539–58.CrossRefPubMed Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21:1539–58.CrossRefPubMed
25.
go back to reference Wetterslev J, Thorlund K, Brok J, et al. Estimating required information size by quantifying diversity in random-effects model meta-analyses. BMC Med Res Methodol. 2009;9:86.CrossRefPubMedPubMedCentral Wetterslev J, Thorlund K, Brok J, et al. Estimating required information size by quantifying diversity in random-effects model meta-analyses. BMC Med Res Methodol. 2009;9:86.CrossRefPubMedPubMedCentral
26.
go back to reference Thompson SG, Sharp SJ. Explaining heterogeneity in meta-analysis: a comparison of methods. Stat Med. 1999;18:2693–708.CrossRefPubMed Thompson SG, Sharp SJ. Explaining heterogeneity in meta-analysis: a comparison of methods. Stat Med. 1999;18:2693–708.CrossRefPubMed
27.
go back to reference Higgins JP, Thompson SG. Controlling the risk from spurious findings from meta-regression. Stat Med. 2004;23:1663–82.CrossRefPubMed Higgins JP, Thompson SG. Controlling the risk from spurious findings from meta-regression. Stat Med. 2004;23:1663–82.CrossRefPubMed
28.
go back to reference Egger M, Davey Smith G, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. B Med J. 1997;315:629–34.CrossRef Egger M, Davey Smith G, Schneider M, et al. Bias in meta-analysis detected by a simple, graphical test. B Med J. 1997;315:629–34.CrossRef
29.
go back to reference Bassi C, Molinari E, Malleo G, et al. Early versus late drain removal after standard pancreatic resections: results of a prospective randomized trial. Ann Surg. 2010;252:207–14.CrossRefPubMed Bassi C, Molinari E, Malleo G, et al. Early versus late drain removal after standard pancreatic resections: results of a prospective randomized trial. Ann Surg. 2010;252:207–14.CrossRefPubMed
30.
go back to reference McMillan MT, Malleo G, Bassi C, et al. Drain management after pancreatoduodenectomy: reappraisal of a prospective randomized trial using risk stratification. J Am Coll Surg. 2015;221(4):798–809.CrossRefPubMed McMillan MT, Malleo G, Bassi C, et al. Drain management after pancreatoduodenectomy: reappraisal of a prospective randomized trial using risk stratification. J Am Coll Surg. 2015;221(4):798–809.CrossRefPubMed
31.
go back to reference Dembinski J, Mariette C, Tuech JJ, et al. Early removal of intraperitoneal drainage after pancreatoduodenectomy in patients without postoperative fistula at POD3: results of a randomized clinical trial. J Visc Surg. 2019;156(2):103–12.CrossRefPubMed Dembinski J, Mariette C, Tuech JJ, et al. Early removal of intraperitoneal drainage after pancreatoduodenectomy in patients without postoperative fistula at POD3: results of a randomized clinical trial. J Visc Surg. 2019;156(2):103–12.CrossRefPubMed
32.
go back to reference Dai M, Xing Liu Q, C, et al. Early drain removal after major pancreatectomy reduces postoperative complications: a single-center, randomized, controlled trial. J Pancreatol. 2020;3:2. Dai M, Xing Liu Q, C, et al. Early drain removal after major pancreatectomy reduces postoperative complications: a single-center, randomized, controlled trial. J Pancreatol. 2020;3:2.
33.
go back to reference Dai M, Liu Q, Xing C, et al. Early drain removal is safe in patients with low or intermediate risk of pancreatic fistula after pancreaticoduodenectomy: a multicenter, randomized controlled trial. Ann Surg. 2022;275:e307–14.CrossRefPubMed Dai M, Liu Q, Xing C, et al. Early drain removal is safe in patients with low or intermediate risk of pancreatic fistula after pancreaticoduodenectomy: a multicenter, randomized controlled trial. Ann Surg. 2022;275:e307–14.CrossRefPubMed
35.
go back to reference Yamashita K, Kato D, Sasaki T, et al. Contaminated drainage fluid and pancreatic fistula after pancreatoduodenectomy: a retrospective study. Int J Surg. 2018;52:314–9.CrossRefPubMed Yamashita K, Kato D, Sasaki T, et al. Contaminated drainage fluid and pancreatic fistula after pancreatoduodenectomy: a retrospective study. Int J Surg. 2018;52:314–9.CrossRefPubMed
36.
go back to reference Hu Y, Zhao Y, Liao Q, et al. Relationship between the pancreatic fistulae and the bacterial culture of abdominal draining fluid after pancreatic operations. Chin J Pract Surg. 2008:53–55. Hu Y, Zhao Y, Liao Q, et al. Relationship between the pancreatic fistulae and the bacterial culture of abdominal draining fluid after pancreatic operations. Chin J Pract Surg. 2008:53–55.
37.
go back to reference Marchegiani G, Di Gioia A, Giuliani T, et al. Delayed gastric emptying after pancreatoduodenectomy: one complication, two different entities. Surgery. 2023;173:1240–7.CrossRefPubMed Marchegiani G, Di Gioia A, Giuliani T, et al. Delayed gastric emptying after pancreatoduodenectomy: one complication, two different entities. Surgery. 2023;173:1240–7.CrossRefPubMed
38.
go back to reference Ricci C, Serbassi F, Alberici L, et al. Value of immunonutrition in patients undergoing pancreatic resection: a trial sequential meta-analysis. HPB. 2023;25:1151–60.CrossRefPubMed Ricci C, Serbassi F, Alberici L, et al. Value of immunonutrition in patients undergoing pancreatic resection: a trial sequential meta-analysis. HPB. 2023;25:1151–60.CrossRefPubMed
Metadata
Title
Early Versus Late Drainage Removal in Patients Who Underwent Pancreaticoduodenectomy: A Comprehensive Systematic Review and Meta-analysis of Randomized Controlled Trials Using Trial Sequential Analysis
Authors
Claudio Ricci, MD, PhD
Davide Giovanni Grego, MD
Laura Alberici, MD
Carlo Ingaldi, MD, PhD
Stefano Togni, MD
Ermenegilda De Dona, MD
Riccardo Casadei, MD
Publication date
24-02-2024
Publisher
Springer International Publishing
Published in
Annals of Surgical Oncology / Issue 5/2024
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-024-14959-w

Other articles of this Issue 5/2024

Annals of Surgical Oncology 5/2024 Go to the issue