DRAPA trial--closed-suction drains versus closed gravity drains in pancreatic surgery: study protocol for a randomized controlled trial
Language English Country England, Great Britain Media electronic
Document type Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
25947117
PubMed Central
PMC4470087
DOI
10.1186/s13063-015-0706-1
PII: 10.1186/s13063-015-0706-1
Knihovny.cz E-resources
- MeSH
- Time Factors MeSH
- Equipment Design MeSH
- Drainage adverse effects instrumentation methods MeSH
- Gravitation MeSH
- Clinical Protocols MeSH
- Humans MeSH
- Suction MeSH
- Pancreatectomy * adverse effects MeSH
- Pancreatic Fistula etiology prevention & control MeSH
- Pancreaticoduodenectomy * adverse effects MeSH
- Prospective Studies MeSH
- Risk Factors MeSH
- Pressure MeSH
- Treatment Outcome MeSH
- Research Design MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Geographicals
- Czech Republic MeSH
BACKGROUND: The morbidity of pancreatic resection remains high, with pancreatic fistula being the most common cause. The important question is whether any postoperative treatment adjustment may prevent the development of clinically significant postoperative pancreatic fistulae. Recent studies have shown that intraabdominal drains and manipulation using them are of great importance. Although authors of a few retrospective reports have described good results of pancreatic resection without the use of intraabdominal drains, a recent prospective randomized trial showed that routine elimination of drains in pancreaticoduodenectomy is associated with poor outcome. An important issue arises as to which type of drain is most suitable for pancreatic resection. Two types of surgical drains exist: open drains and closed drains. Open drains are considered obsolete nowadays because of frequent retrograde infection. Closed drains include two types: passive gravity drains and closed-suction drains. Closed-suction drains are more effective, as they remove fluid from the abdominal cavity under light pressure. However, some surgeons believe that closed-suction drains represent a potential hazard to patients and that negative pressure might increase the risk of pancreatic fistulae. Nobody has yet specifically dealt with the question of which kind of drainage is most appropriate in pancreatic surgery. METHODS/DESIGN: The aim of the DRAins in PAncreatic surgery (DRAPA) trial is to compare the closed-suction drain versus the closed passive gravity drain in pancreatic resection. DRAPA is a dual-centre, prospective, randomized controlled trial. The primary endpoint is the rate of postoperative pancreatic fistula; the secondary endpoint is postoperative morbidity with follow-up of 3 months. DISCUSSION: No study to date has compared different types of drains in pancreatic surgery. This study is designed to answer the question whether any particular type of drain might lower the rate of postoperative pancreatic fistula or other complications. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01988519. Registered 13 November 2013.
See more in PubMed
Hartwig W, Werner J, Jäger D, Debus J, Büchler MW. Improvement of surgical results for pancreatic cancer. Lancet Oncol. 2013;14:e476–85. doi: 10.1016/S1470-2045(13)70172-4. PubMed DOI
Čečka F, Jon B, Šubrt Z, Ferko A. Clinical and economic consequences of pancreatic fistula after elective pancreatic resection. Hepatobiliary Pancreat Dis Int. 2013;12:533–9. doi: 10.1016/S1499-3872(13)60084-3. PubMed DOI
Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, et al. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011;377:1514–22. doi: 10.1016/S0140-6736(11)60237-7. PubMed DOI
Butturini G, Daskalaki D, Molinari E, Scopelliti F, Casarotto A, Bassi C. Pancreatic fistula: definition and current problems. J Hepatobiliary Pancreat Surg. 2008;15:247–51. doi: 10.1007/s00534-007-1301-y. PubMed DOI
Pratt WB, Maithel SK, Vanounou T, Huang ZS, Callery MP, Vollmer CM., Jr Clinical and economic validation of the International Study Group of Pancreatic Fistula (ISGPF) classification scheme. Ann Surg. 2007;245:443–51. doi: 10.1097/01.sla.0000251708.70219.d2. PubMed DOI PMC
Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, et al. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005;138:8–13. doi: 10.1016/j.surg.2005.05.001. PubMed DOI
Čečka F, Jon B, Šubrt Z, Ferko A. The effect of somatostatin and its analogs in the prevention of pancreatic fistula after elective pancreatic surgery. Eur Surg. 2012;44:99–108. doi: 10.1007/s10353-011-0612-z. DOI
Kawai M, Yamaue H. Analysis of clinical trials evaluating complications after pancreaticoduodenectomy: a new era of pancreatic surgery. Surg Today. 2010;40:1011–7. doi: 10.1007/s00595-009-4245-9. PubMed DOI
Yang SH, Dou KF, Sharma N, Song WJ. The methods of reconstruction of pancreatic digestive continuity after pancreaticoduodenectomy: a meta-analysis of randomized controlled trials. World J Surg. 2011;35:2290–7. doi: 10.1007/s00268-011-1159-7. PubMed DOI
Čečka F, Jon B, Šubrt Z, Ferko A. Surgical technique in distal pancreatectomy: a systematic review of randomized trials. Biomed Res Int. 2014;2014:482906. PubMed PMC
Diener MK, Tadjalli-Mehr K, Wente MN, Kieser M, Büchler MW, Seiler CM. Risk–benefit assessment of closed intra-abdominal drains after pancreatic surgery: a systematic review and meta-analysis assessing the current state of evidence. Langenbecks Arch Surg. 2011;396:41–52. doi: 10.1007/s00423-010-0716-0. PubMed DOI
Strobel O, Büchler MW. Drainage after pancreaticoduodenectomy: controversy revitalized. Ann Surg. 2014;259:613–5. doi: 10.1097/SLA.0000000000000630. PubMed DOI
Wang Q, Jiang YJ, Li J, Yang F, Di Y, Yao L, et al. Is routine drainage necessary after pancreaticoduodenectomy? World J Gastroenterol. 2014;20:8110–8. doi: 10.3748/wjg.v20.i25.8110. PubMed DOI PMC
Conlon KC, Labow D, Leung D, Smith A, Jarnagin W, Coit DG, et al. Prospective randomized clinical trial of the value of intraperitoneal drainage after pancreatic resection. Ann Surg. 2001;234:487–94. doi: 10.1097/00000658-200110000-00008. PubMed DOI PMC
Bassi C, Molinari E, Malleo G, Crippa S, Butturini G, Salvia R, et al. Early versus late drain removal after standard pancreatic resections: results of a prospective randomized trial. Ann Surg. 2010;252:207–14. doi: 10.1097/SLA.0b013e3181e61e88. PubMed DOI
Büchler MW, Friess H. Evidence forward, drainage on retreat: still we ignore and drain!? Ann Surg. 2006;244:8–9. doi: 10.1097/01.sla.0000225046.43968.eb. PubMed DOI PMC
Shrikhande SV, Barreto SG, Shetty G, Suradkar K, Bodhankar YD, Shah SB, et al. Post-operative abdominal drainage following major upper gastrointestinal surgery: single drain versus two drains. J Cancer Res Ther. 2013;9:267–71. doi: 10.4103/0973-1482.113380. PubMed DOI
Balzano G, Zerbi A, Cristallo M, Di Carlo V. The unsolved problem of fistula after left pancreatectomy: the benefit of cautious drain management. J Gastrointest Surg. 2005;9:837–42. doi: 10.1016/j.gassur.2005.01.287. PubMed DOI
Petrowsky H, Demartines N, Rousson V, Clavien PA. Evidence-based value of prophylactic drainage in gastrointestinal surgery: a systematic review and meta-analyses. Ann Surg. 2004;240:1074–85. doi: 10.1097/01.sla.0000146149.17411.c5. PubMed DOI PMC
Čečka F, Sotona O, Šubrt Z. How to distinguish between surgical and non-surgical pneumoperitoneum? Signa Vitae. 2014;9(1):1.
Molinari E, Bassi C, Salvia R, Butturini G, Crippa S, Talamini G, et al. 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;246:281–7. doi: 10.1097/SLA.0b013e3180caa42f. PubMed DOI PMC
Lee CW, Pitt HA, Riall TS, Ronnekleiv-Kelly SS, Israel JS, Leverson GE, et al. Low drain fluid amylase predicts absence of pancreatic fistula following pancreatectomy. J Gastrointest Surg. 2014;18:1902–10. doi: 10.1007/s11605-014-2601-6. PubMed DOI PMC
Giovinazzo F, Butturini G, Salvia R, Mascetta G, Monsellato D, Marchegiani G, et al. Drain management after pancreatic resection: state of the art. J Hepatobiliary Pancreat Sci. 2011;18:779–84. doi: 10.1007/s00534-011-0431-4. PubMed DOI
Jeekel J. No abdominal drainage after Whipple’s procedure. Br J Surg. 1992;79:182. doi: 10.1002/bjs.1800790237. PubMed DOI
Van Buren G, II, Bloomston M, Hughes SJ, Winter J, Behrman SW, Zyromski NJ, et al. A randomized prospective multicenter trial of pancreaticoduodenectomy with and without routine intraperitoneal drainage. Ann Surg. 2014;259:605–12. doi: 10.1097/SLA.0000000000000460. PubMed DOI
Kawai M, Tani M, Terasawa H, Ina S, Hirono S, Nishioka R, 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. doi: 10.1097/01.sla.0000218077.14035.a6. PubMed DOI PMC
Sarr MG, Parikh KJ, Minken SL, Zuidema GD, Cameron JL. Closed-suction versus Penrose drainage after cholecystectomy: a prospective, randomized evaluation. Am J Surg. 1987;153:394–8. doi: 10.1016/0002-9610(87)90585-X. PubMed DOI
Correa-Gallego C, Brennan MF, D’Angelica M, Fong Y, Dematteo RP, Kingham TP, et al. Operative drainage following pancreatic resection: analysis of 1122 patients resected over 5 years at a single institution. Ann Surg. 2013;258:1051–8. doi: 10.1097/SLA.0b013e3182813806. PubMed DOI PMC
Fisher WE, Hodges SE, Silberfein EJ, Artinyan A, Ahern CH, Jo E, et al. Pancreatic resection without routine intraperitoneal drainage. HPB (Oxford). 2011;13:503–10. doi: 10.1111/j.1477-2574.2011.00331.x. PubMed DOI PMC
Hassenpflug M, Bruckner T, Knebel P, Diener MK, Büchler MW, Werner J. DISCOVER trial – Distal resection of the pancreas with or without coverage of the pancreatic remnant: study protocol of a randomised controlled trial. Trials. 2013;14:430. doi: 10.1186/1745-6215-14-430. PubMed DOI PMC
Schmidt CM, Choi J, Powell ES, Yiannoutsos CT, Zyromski NJ, Nakeeb A, et al. Pancreatic fistula following pancreaticoduodenectomy: clinical predictors and patient outcomes. HPB Surg. 2009;2009:404520. doi: 10.1155/2009/404520. PubMed DOI PMC
Yoshikawa K, Konishi M, Takahashi S, Gotohda N, Kato Y, Kinoshita T. Surgical management for the reduction of postoperative hospital stay following distal pancreatectomy. Hepatogastroenterology. 2011;58:1389–93. doi: 10.5754/hge10811. PubMed DOI
Grobmyer SR, Graham D, Brennan MF, Coit D. High-pressure gradients generated by closed-suction surgical drainage systems. Surg Infect (Larchmt). 2002;3:245–9. doi: 10.1089/109629602761624207. PubMed DOI
Schmidt CM, Turrini O, Parikh P, House MG, Zyromski NJ, Nakeeb A, et al. Effect of hospital volume, surgeon experience, and surgeon volume on patient outcomes after pancreaticoduodenectomy: a single-institution experience. Arch Surg. 2010;145:634–40. doi: 10.1001/archsurg.2010.118. PubMed DOI
Cheng Q, Zhang B, Zhang Y, Jiang X, Zhang B, Yi B, et al. Predictive factors for complications after pancreaticoduodenectomy. J Surg Res. 2007;139:22–9. doi: 10.1016/j.jss.2006.07.028. PubMed DOI
Lin JW, Cameron JL, Yeo CJ, Riall TS, Lillemoe KD. Risk factors and outcomes in postpancreaticoduodenectomy pancreaticocutaneous fistula. J Gastrointest Surg. 2004;8:951–9. doi: 10.1016/j.gassur.2004.09.044. PubMed DOI
Hiyoshi M, Chijiiwa K, Fujii Y, Imamura N, Nagano M, Ohuchida J. Usefulness of drain amylase, serum C-reactive protein levels and body temperature to predict postoperative pancreatic fistula after pancreaticoduodenectomy. World J Surg. 2013;37:2436–42. doi: 10.1007/s00268-013-2149-8. PubMed DOI
Koch M, Garden OJ, Padbury R, Rahbari NN, Adam R, Capussotti L, et al. Bile leakage after hepatobiliary and pancreatic surgery: a definition and grading of severity by the International Study Group of Liver Surgery. Surgery. 2011;149:680–8. doi: 10.1016/j.surg.2010.12.002. PubMed DOI
Sierzega M, Kulig P, Kolodziejczyk P, Kulig J. Natural history of intra-abdominal fluid collections following pancreatic surgery. J Gastrointest Surg. 2013;17:1406–13. doi: 10.1007/s11605-013-2234-1. PubMed DOI PMC
Wente MN, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, Izbicki JR, 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. doi: 10.1016/j.surg.2007.05.005. PubMed DOI
Wente MN, Veit JA, Bassi C, Dervenis C, Fingerhut A, Gouma DJ, et al. Postpancreatectomy hemorrhage (PPH): an International Study Group of Pancreatic Surgery (ISGPS) definition. Surgery. 2007;142:20–5. doi: 10.1016/j.surg.2007.02.001. PubMed DOI
DeOliveira ML, Winter JM, Schafer M, Cunningham SC, Cameron JL, Yeo CJ, et al. Assessment of complications after pancreatic surgery: a novel grading system applied to 633 patients undergoing pancreaticoduodenectomy. Ann Surg. 2006;244:931–9. doi: 10.1097/01.sla.0000246856.03918.9a. PubMed DOI PMC
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205–13. doi: 10.1097/01.sla.0000133083.54934.ae. PubMed DOI PMC
Pratt W, Maithel SK, Vanounou T, Callery MP, Vollmer CM., Jr Postoperative pancreatic fistulas are not equivalent after proximal, distal, and central pancreatectomy. J Gastrointest Surg. 2006;10:1264–79. doi: 10.1016/j.gassur.2006.07.011. PubMed DOI
Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Med Res Methodol. 2001;1:2. doi: 10.1186/1471-2288-1-2. PubMed DOI PMC
McMillan MT, Fisher WE, Van Buren G, II, McElhany A, Bloomston M, Hughes SJ, et al. The value of drains as a fistula mitigation strategy for pancreatoduodenectomy: something for everyone? Results of a randomized prospective multi-institutional study. J Gastrointest Surg. 2015;19:21–31. doi: 10.1007/s11605-014-2640-z. PubMed DOI
Rondelli F, Desio M, Vedovati MC, Balzarotti Canger RC, Sanguinetti A, Avenia N, et al. Intra-abdominal drainage after pancreatic resection: Is it really necessary? A meta-analysis of short-term outcomes. Int J Surg. 2014;12(Suppl 1):S40–7. doi: 10.1016/j.ijsu.2014.05.002. PubMed DOI
Intra-abdominal drainage following pancreatic resection: A systematic review
ClinicalTrials.gov
NCT01988519