Redefining the Role of Drain Amylase Value for a Risk-Based Drain Management after Pancreaticoduodenectomy: Early Drain Removal Still Is Beneficial.
Amylases
Drainage
Enhanced recovery after surgery
Outcome
Pancreas
Journal
Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract
ISSN: 1873-4626
Titre abrégé: J Gastrointest Surg
Pays: United States
ID NLM: 9706084
Informations de publication
Date de publication:
06 2021
06 2021
Historique:
received:
05
04
2020
accepted:
13
05
2020
pubmed:
5
6
2020
medline:
10
7
2021
entrez:
5
6
2020
Statut:
ppublish
Résumé
The application of postoperative pancreatic fistula (POPF) risk stratification and mitigation strategies requires an update of the protocol for an early drain removal after pancreaticoduodenectomy (PD). The aim of the study is to highlight the unreliability of a single drain fluid amylase (DFA) cutoff-based protocol in the setting of a risk-based drain management. The role of postoperative day one (POD1) DFA in predicting POPF was explored in the setting of both selective drain placement and early drain removal protocols. Receiver operating characteristics (ROC) curves were used to assess the POPF diagnostic performance in terms of negative predictive value (NPV) of several POD1 DFA cutoffs in different clinical scenarios according to POPF risk and mitigation strategies. The areas under the curve (AUCs) for POD1-DFA were 0.815 for intermediate risk and pancreaticojejunostomy (PJ) (best cutoff 1000 IU/L, NPV 92.9%), 0.712 for intermediate risk and PJ with external stent (best cutoff 1000 IU/L, NPV 88.8%), and 0.574 for high risk and external stent (best cutoff 250 IU/L, NPV 93.7%). Independent predictors of POPF were body mass index, pancreatic texture, and early drain removal, whereas POD1 DFA was not. In the era of risk stratification and mitigation strategies, selective early drain removal still is associated with a reduced rate of POPF. However, a single protocol based on POD1-DFA is not suitable for all clinical scenarios after PD.
Sections du résumé
BACKGROUND
The application of postoperative pancreatic fistula (POPF) risk stratification and mitigation strategies requires an update of the protocol for an early drain removal after pancreaticoduodenectomy (PD). The aim of the study is to highlight the unreliability of a single drain fluid amylase (DFA) cutoff-based protocol in the setting of a risk-based drain management.
METHODS
The role of postoperative day one (POD1) DFA in predicting POPF was explored in the setting of both selective drain placement and early drain removal protocols. Receiver operating characteristics (ROC) curves were used to assess the POPF diagnostic performance in terms of negative predictive value (NPV) of several POD1 DFA cutoffs in different clinical scenarios according to POPF risk and mitigation strategies.
RESULTS
The areas under the curve (AUCs) for POD1-DFA were 0.815 for intermediate risk and pancreaticojejunostomy (PJ) (best cutoff 1000 IU/L, NPV 92.9%), 0.712 for intermediate risk and PJ with external stent (best cutoff 1000 IU/L, NPV 88.8%), and 0.574 for high risk and external stent (best cutoff 250 IU/L, NPV 93.7%). Independent predictors of POPF were body mass index, pancreatic texture, and early drain removal, whereas POD1 DFA was not.
CONCLUSION
In the era of risk stratification and mitigation strategies, selective early drain removal still is associated with a reduced rate of POPF. However, a single protocol based on POD1-DFA is not suitable for all clinical scenarios after PD.
Identifiants
pubmed: 32495136
doi: 10.1007/s11605-020-04658-8
pii: 10.1007/s11605-020-04658-8
doi:
Substances chimiques
Amylases
EC 3.2.1.-
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1461-1470Références
Lassen K, Coolsen MME, Slim K, Carli F, de Aguilar-Nascimento JE, Schäfer M, Parks RW, Fearon KCH, Lobo DN, Demartines N, Braga M, Ljungqvist O, Dejong CHC, ERAS®Society, European Society for Clinical Nutrition and Metabolism, International Association for Surgical Metabolism and Nutrition. Guidelines for perioperative care for pancreaticoduodenectomy: Enhanced Recovery After Surgery (ERAS®) Society recommendations. Clin Nutr. 2012. 31 (6), 817-30
doi: 10.1016/j.clnu.2012.08.011
Bassi C, Molinari E, Malleo G, Crippa S, Butturini G, Salvia R, Talamini G, Pederzoli P. Early versus late drain removal after standard pancreatic resections: results of a prospective randomized trial. Ann Surg. 2010;252(2):207–14.
doi: 10.1097/SLA.0b013e3181e61e88
Kawai M, Tani M, Terasawa H, Ina S, Hirono S, Nishioka R, Miyazawa M, Uchiyama K, Yamaue H. 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), 1-7
doi: 10.1097/01.sla.0000218077.14035.a6
Giglio MC, Spalding DRC, Giakoustidis A, Zarzavadjian Le Bian A, Jiao LR, Habib NA, Pai M. Meta-analysis of drain amylase content on postoperative day 1 as a predictor of pancreatic fistula following pancreatic resection. British Journal of Surgery. 2016. 103 (4), 328-36
doi: 10.1002/bjs.10090
Israel JS, Rettammel RJ, Leverson GE, Hanks LR, Cho CS, Winslow ER, Weber SM. Does postoperative drain amylase predict pancreatic fistula after pancreatectomy? J Am Coll Surg, 2014; 218 (5), 978-87
doi: 10.1016/j.jamcollsurg.2014.01.048
Lee CW, Pitt HA, Riall TS, Ronnekleiv-Kelly SS, Israel JS, Leverson GE, Parmar AD, Kilbane EM, Hall BL, Weber SM. Low Drain Fluid Amylase Predicts Absence of Pancreatic Fistula Following Pancreatectomy. J Gastrointest Surg. 2014; 18 (11), 1902-10
doi: 10.1007/s11605-014-2601-6
Shinchi H, Wada K, Traverso LW. The Usefulness of Drain Data to Identify a Clinically Relevant Pancreatic Anastomotic Leak After Pancreaticoduodenectomy? J Gastrointest Surg. 2006; 10 (4), 490-8
doi: 10.1016/j.gassur.2005.08.029
Molinari E, Bassi C, Salvia R, Butturini G, Crippa S, Talamini G, Falconi M, Pederzoli P. Amylase value in drains after pancreatic resection as predictive factor of postoperative pancreatic fistula: results of a prospective study in 137 patients. Ann Surg. 2007;246(2):281–7.
doi: 10.1097/SLA.0b013e3180caa42f
Moskovic DJ, Hodges SE, Wu MF, Brunicardi FC, Hilsenbeck SG, Fisher WE. Drain data to predict clinically relevant pancreatic fistula. HPB. 2010; 12 (7), 472-81
doi: 10.1111/j.1477-2574.2010.00212.x
Nissen NN, Menon VG, Puri V, Annamalai A, Boland B. A simple algorithm for drain management after pancreaticoduodenectomy. Am Surg. 2012; 78 (10), 1143-6
doi: 10.1177/000313481207801029
Sutcliffe RP, Battula N, Haque A, Ali A, Srinivasan P, Atkinson SW, Rela M, Heaton ND, Prachalias AA. Utility of drain fluid amylase measurement on the first postoperative day after pancreaticoduodenectomy. World J Surg. 2012; 36 (4), 879-83
doi: 10.1007/s00268-012-1460-0
El Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T. Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single center experience). World J Surg. 2013;37(6):1405–18.
doi: 10.1007/s00268-013-1998-5
Partelli S, Tamburrino D, Crippa S, Facci E, Zardini C, Falconi M. Evaluation of a predictive model for pancreatic fistula based on amylase value in drains after pancreatic resection. Am J Surg. 2014; 208 (4), 634-9
doi: 10.1016/j.amjsurg.2014.03.011
McMillan MT, Malleo G, Bassi C, Sprys MH, Vollmer CM. Defining the practice of pancreatoduodenectomy around the world. HPB (Oxford). 2015;17(12):1145–54.
doi: 10.1111/hpb.12475
Davidson TBU, Yaghoobi M, Davidson BR, Gurusamy KS. Amylase in drain fluid for the diagnosis of pancreatic leak in post-pancreatic resection. Cochrane Database Syst Rev; 2017. 4 (4), CD012009
Callery MP, Pratt WB, Kent TS, Chaikof EL, Vollmer CM. A prospectively validated clinical risk score accurately predicts pancreatic fistula after pancreatoduodenectomy. J Am Coll Surg. 2013;216(1):1–14.
doi: 10.1016/j.jamcollsurg.2012.09.002
Ecker BL, McMillan MT, Asbun HJ, Ball CG, Bassi C, Beane JD, Behrman SW, Berger AC, Dickson EJ, Bloomston M, Callery MP, Christein JD, Dixon E, Drebin JA, Castillo CF Del, Fisher WE, Fong ZV, Haverick E, Hollis RH, House MG, Hughes SJ, Jamieson NB, Javed AA, Kent TS, Kowalsky SJ, Kunstman JW, Malleo G, Poruk KE, Salem RR, Schmidt CR, Soares K, Stauffer JA, Valero V, Velu LKP, Watkins AA, Wolfgang CL, Zureikat AH, Vollmer CM. Characterization and Optimal Management of High-risk Pancreatic Anastomoses during Pancreatoduodenectomy. Ann Surg. 2018;267(4):608-616
doi: 10.1097/SLA.0000000000002327
McMillan MT, Malleo G, Bassi C, Allegrini V, Casetti L, Drebin JA, Esposito A, Landoni L, Lee MK, Pulvirenti A, Roses RE, Salvia R, Vollmer CM. Multicenter, Prospective Trial of Selective Drain Management for Pancreatoduodenectomy Using Risk Stratification. Ann Surg, 2017; 265 (6), 1209-1218
doi: 10.1097/SLA.0000000000001832
Andrianello S, Marchegiani G, Malleo G, Masini G, Balduzzi A, Paiella S, Esposito A, Landoni L, Casetti L, Tuveri M, Salvia R, Bassi C. Pancreaticojejunostomy with Externalized Stent vs Pancreaticogastrostomy with Externalized Stent for Patients with High-Risk Pancreatic Anastomosis: A Single-Center, Phase 3, Randomized Clinical Trial. JAMA Surg. 2020 Feb 26[Online ahead of print]
Beane JD, House MG, Ceppa EP, Dolejs SC, Pitt HA. Variation in Drain Management After Pancreatoduodenectomy: Early Versus Delayed Removal. Ann Surg. 2019; 269 (4), 718-724
doi: 10.1097/SLA.0000000000002570
McMillan MT, Malleo G, Bassi C, Sprys MH, Ecker BL, Drebin JA, Vollmer CM. Pancreatic fistula risk for pancreatoduodenectomy: an international survey of surgeon perception. HPB. 2017; 19 (6), 515-524
doi: 10.1016/j.hpb.2017.01.022
Bassi C, Falconi M, Molinari E, Salvia R, Butturini G, Sartori N, Mantovani W, Pederzoli P. Reconstruction by pancreaticojejunostomy versus pancreaticogastrostomy following pancreatectomy: results of a comparative study. Ann Surg. 2005;242(6):767–71, discussion 771-773.
doi: 10.1097/01.sla.0000189124.47589.6d
Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernández-del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CR, Wolfgang CL, Yeo CJ, Salvia R, Buchler M, International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017;161(3):584–91.
doi: 10.1016/j.surg.2016.11.014
Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Yeo CJ, Büchler MW. Postpancreatectomy hemorrhage (PPH)-An International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007;142(1):20–5.
doi: 10.1016/j.surg.2007.02.001
Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, Neoptolemos JP, Padbury RT, Sarr MG, Traverso LW, Yeo CJ, Büchler MW. Delayed gastric emptying (DGE) after pancreatic surgery: a suggested definition by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2007; 142 (5), 761-8
doi: 10.1016/j.surg.2007.05.005
Dindo D, Demartines N, Clavien P-A. Classification of Surgical Complications. A New Proposal With Evaluation in a Cohort of 6336 Patients and Results of a Survey. Ann Surg. 2004;240(2):205–13.
doi: 10.1097/01.sla.0000133083.54934.ae
Seykora TF, Maggino L, Malleo G, Lee MK, Roses R, Salvia R, Bassi C, Vollmer CM. Evolving the Paradigm of Early Drain Removal Following Pancreatoduodenectomy. J Gastrointest Surg. 2019; 23 (1), 135-144
doi: 10.1007/s11605-018-3959-7
Trudeau MT, Maggino L, Chen B, McMillan MT, Lee MK, Roses R, DeMatteo R, Drebin JA, Vollmer CM. Extended Experience with a Dynamic, Data-Driven Selective Drain Management Protocol in Pancreatoduodenectomy: Progressive Risk Stratification for Better Practice. J Am Coll Surg. 2020 Feb 17[Online ahead of print]
Xourafas D, Ejaz A, Tsung A, Dillhoff M, Pawlik TM, Cloyd JM. Validation of early drain removal after pancreatoduodenectomy based on modified fistula risk score stratification: a population-based assessment. HPB. 2019; 21 (10), 1303-1311
doi: 10.1016/j.hpb.2019.02.002
Kantor O, Talamonti MS, Pitt HA, Vollmer CM, Riall TS, Hall BL, Wang CH, Baker MS. Using the NSQIP Pancreatic Demonstration Project to Derive a Modified Fistula Risk Score for Preoperative Risk Stratification in Patients Undergoing Pancreaticoduodenectomy. J Am Coll Surg, 2017; 224 (5), 816-825
doi: 10.1016/j.jamcollsurg.2017.01.054
Ven Fong Z, Correa-Gallego C, Ferrone CR, Veillette GR, Warshaw AL, Lillemoe KD, Fernández-Del Castillo C. Early drain removal - The middle ground between the drain versus no drain debate in patients undergoing pancreaticoduodenectomy: A prospective validation study. Ann Surg. 2015. 262 (2), 378-83
doi: 10.1097/SLA.0000000000001038
Shyr YM, Su CH, Wu CW, Lui WY. Does drainage fluid amylase reflect pancreatic leakage after pancreaticoduodenectomy? World J Surg. 2003; 27 (5), 606-10
doi: 10.1007/s00268-003-6841-y
Maeda E, Kataoka M, Yatsushiro S, Kajimoto K, Hino M, Kaji N, Tokeshi M, Bando M, Kido JI, Ishikawa M, Shinohara Y, Baba Y. Accurate quantitation of salivary and pancreatic amylase activities in human plasma by microchip electrophoretic separation of the substrates and hydrolysates couples with immunoinhibition. Electrophoresis. 2008; 29 (9), 1902-9
doi: 10.1002/elps.200700688
Giuliani T, Andrianello S, Bortolato C, Marchegiani G, De Marchi G, Malleo G, Frulloni L, Bassi C, Salvia R. Preoperative fecal elastase-1 (FE-1) adds value in predicting post-operative pancreatic fistula: not all soft pancreas share the same risk – A prospective analysis on 105 patients. HPB. 2019 Aug 13[Online ahead of print]
Bannone E, Andrianello S, Marchegiani G, Masini G, Malleo G, Bassi C, Salvia R. Postoperative Acute Pancreatitis Following Pancreaticoduodenectomy: A Determinant of Fistula Potentially Driven by the Intraoperative Fluid Management. Ann Surg. 2018; 268 (5), 815-822
doi: 10.1097/SLA.0000000000002900