Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

DRAPA trial – closed-suction drains versus closed gravity drains in pancreatic surgery: study protocol for a randomized controlled trial

Authors: Filip Čečka, Martin Loveček, Bohumil Jon, Pavel Skalický, Zdeněk Šubrt, Alexander Ferko

Published in: Trials | Issue 1/2015

Login to get access

Abstract

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.
Literature
1.
Hartwig W, Werner J, Jäger D, Debus J, Büchler MW. Improvement of surgical results for pancreatic cancer. Lancet Oncol. 2013;14:e476–85.CrossRefPubMed
2.
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.CrossRefPubMed
3.
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.CrossRefPubMed
4.
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.CrossRefPubMed
5.
Pratt WB, Maithel SK, Vanounou T, Huang ZS, Callery MP, Vollmer Jr CM. Clinical and economic validation of the International Study Group of Pancreatic Fistula (ISGPF) classification scheme. Ann Surg. 2007;245:443–51.CrossRefPubMedPubMedCentral
6.
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.CrossRefPubMed
7.
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.CrossRef
8.
Kawai M, Yamaue H. Analysis of clinical trials evaluating complications after pancreaticoduodenectomy: a new era of pancreatic surgery. Surg Today. 2010;40:1011–7.CrossRefPubMed
9.
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.CrossRefPubMed
10.
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.PubMedPubMedCentral
11.
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.CrossRefPubMed
12.
Strobel O, Büchler MW. Drainage after pancreaticoduodenectomy: controversy revitalized. Ann Surg. 2014;259:613–5.CrossRefPubMed
13.
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.CrossRefPubMedPubMedCentral
14.
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.CrossRefPubMedPubMedCentral
15.
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.CrossRefPubMed
16.
17.
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.CrossRefPubMed
18.
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.CrossRefPubMed
19.
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.CrossRefPubMedPubMedCentral
20.
Čečka F, Sotona O, Šubrt Z. How to distinguish between surgical and non-surgical pneumoperitoneum? Signa Vitae. 2014;9(1):1.
21.
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.CrossRefPubMedPubMedCentral
22.
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.CrossRefPubMedPubMedCentral
23.
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.CrossRefPubMed
24.
25.
Van Buren II G, 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.CrossRefPubMed
26.
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.CrossRefPubMedPubMedCentral
27.
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.CrossRefPubMed
28.
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.CrossRefPubMed
29.
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.CrossRefPubMedPubMedCentral
30.
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.CrossRefPubMedPubMedCentral
31.
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.CrossRefPubMedPubMedCentral
32.
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.CrossRefPubMed
33.
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.CrossRefPubMed
34.
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.CrossRefPubMed
35.
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.CrossRefPubMed
36.
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.CrossRefPubMed
37.
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.CrossRefPubMed
38.
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.CrossRefPubMed
39.
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.CrossRefPubMedPubMedCentral
40.
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.CrossRefPubMed
41.
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.CrossRefPubMed
42.
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.CrossRefPubMedPubMedCentral
43.
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.CrossRefPubMedPubMedCentral
44.
Pratt W, Maithel SK, Vanounou T, Callery MP, Vollmer Jr CM. Postoperative pancreatic fistulas are not equivalent after proximal, distal, and central pancreatectomy. J Gastrointest Surg. 2006;10:1264–79.CrossRefPubMed
45.
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.CrossRefPubMedPubMedCentral
46.
McMillan MT, Fisher WE, Van Buren II G, 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.CrossRefPubMed
47.
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.CrossRefPubMed
Metadata
Title
DRAPA trial – closed-suction drains versus closed gravity drains in pancreatic surgery: study protocol for a randomized controlled trial
Authors
Filip Čečka
Martin Loveček
Bohumil Jon
Pavel Skalický
Zdeněk Šubrt
Alexander Ferko
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0706-1

Other articles of this Issue 1/2015

Trials 1/2015 Go to the issue

Research

Similarities and differences between patients included and excluded from a randomized clinical trial of vitamin d supplementation for improving glucose tolerance in prediabetes: interpreting broader applicability

Research

The ethical issues regarding consent to clinical trials with pre-term or sick neonates: a systematic review (framework synthesis) of the empirical research

Methodology

A sample size planning approach that considers both statistical significance and clinical significance

Study protocol

Health allowance for improving the nutritional status and development of 3–5-year-old left-behind children in poor rural areas of China: study protocol for a cluster randomised trial

Research

Who does not participate in telehealth trials and why? A cross-sectional survey

Study protocol

Application effect of extensively hydrolyzed milk protein formula and follow-up in preterm children with a gestational age of less than 34 weeks: study protocol for a randomized controlled trial