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Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial

Markus K Diener, Christoph M Seiler, Inga Rossion, Joerg Kleeff, Matthias Glanemann, Giovanni Butturini, Ales Tomazic, Christiane J Bruns, Olivier RC Busch, Stefan Farkas, et al. (2011) LANCET. 377(9776). p.1514-1522
abstract
Background The ideal closure technique of the pancreas after distal pancreatectomy is unknown. We postulated that standardised closure with a stapler device would prevent pancreatic fistula more effectively than would a hand-sewn closure of the remnant. Methods This multicentre, randomised, controlled, parallel group-sequential superiority trial was done in 21 European hospitals. Patients with diseases of the pancreatic body and tail undergoing distal pancreatectomy were eligible and were randomly assigned by central randomisation before operation to either stapler or hand-sewn closure of the pancreatic remnant. Surgical performance was assessed with intraoperative photo documentation. The primary endpoint was the combination of pancreatic fistula and death until postoperative day 7. Patients and outcome assessors were masked to group assignment. Interim and final analysis were by intention to treat in all patients in whom a left resection was done. This trial is registered, ISRCTN18452029. Findings Between Nov 16, 2006, and July 3, 2009, 450 patients were randomly assigned to treatment groups (221 stapler; 229 hand-sewn closure), of whom 352 patients (177 stapler, 175 hand-sewn closure) were analysed. Pancreatic fistula rate or mortality did not differ between stapler (56 [32%] of 177) and hand-sewn closure (49 [28%] of 175; OR 0.84, 95% CI 0.53-1.33; p=0.56). One patient died within the first 7 days after surgery in the hand-sewn group; no deaths occurred in the stapler group. Serious adverse events did not differ between groups. Interpretation Stapler closure did not reduce the rate of pancreatic fistula compared with hand-sewn closure for distal pancreatectomy. New strategies, including innovative surgical techniques, need to be identified to reduce this adverse outcome.
Please use this url to cite or link to this publication:
author
organization
year
type
journalArticle (original)
publication status
published
subject
keyword
FISTULA, RISK-FACTORS, METAANALYSIS, MANAGEMENT, MORBIDITY, MORTALITY, LEAK
journal title
LANCET
Lancet
volume
377
issue
9776
pages
1514 - 1522
Web of Science type
Article
Web of Science id
000290419400029
JCR category
MEDICINE, GENERAL & INTERNAL
JCR impact factor
38.278 (2011)
JCR rank
2/153 (2011)
JCR quartile
1 (2011)
ISSN
0140-6736
DOI
10.1016/S0140-6736(11)60237-7
language
English
UGent publication?
yes
classification
A1
copyright statement
I have transferred the copyright for this publication to the publisher
id
1855612
handle
http://hdl.handle.net/1854/LU-1855612
date created
2011-07-08 09:36:03
date last changed
2016-12-19 15:42:17
@article{1855612,
  abstract     = {Background The ideal closure technique of the pancreas after distal pancreatectomy is unknown. We postulated that standardised closure with a stapler device would prevent pancreatic fistula more effectively than would a hand-sewn closure of the remnant. Methods This multicentre, randomised, controlled, parallel group-sequential superiority trial was done in 21 European hospitals. Patients with diseases of the pancreatic body and tail undergoing distal pancreatectomy were eligible and were randomly assigned by central randomisation before operation to either stapler or hand-sewn closure of the pancreatic remnant. Surgical performance was assessed with intraoperative photo documentation. The primary endpoint was the combination of pancreatic fistula and death until postoperative day 7. Patients and outcome assessors were masked to group assignment. Interim and final analysis were by intention to treat in all patients in whom a left resection was done. This trial is registered, ISRCTN18452029. Findings Between Nov 16, 2006, and July 3, 2009, 450 patients were randomly assigned to treatment groups (221 stapler; 229 hand-sewn closure), of whom 352 patients (177 stapler, 175 hand-sewn closure) were analysed. Pancreatic fistula rate or mortality did not differ between stapler (56 [32\%] of 177) and hand-sewn closure (49 [28\%] of 175; OR 0.84, 95\% CI 0.53-1.33; p=0.56). One patient died within the first 7 days after surgery in the hand-sewn group; no deaths occurred in the stapler group. Serious adverse events did not differ between groups. Interpretation Stapler closure did not reduce the rate of pancreatic fistula compared with hand-sewn closure for distal pancreatectomy. New strategies, including innovative surgical techniques, need to be identified to reduce this adverse outcome.},
  author       = {Diener, Markus K and Seiler, Christoph M and Rossion, Inga and Kleeff, Joerg and Glanemann, Matthias and Butturini, Giovanni and Tomazic, Ales and Bruns, Christiane J and Busch, Olivier RC and Farkas, Stefan and Belyaev, Orlin and Neoptolemos, John P and Halloran, Christopher and Keck, Tobias and Niedergethmann, Marco and Gellert, Klaus and Witzigmann, Helmut and Kollmar, Otto and Langer, Peter and Steger, Ulrich and Neudecker, Jens and Berrevoet, Frederik and Ganzera, Silke and Heiss, Markus M and Luntz, Steffen P and Bruckner, Thomas and Kieser, Meinhard and Buchler, Markus W},
  issn         = {0140-6736},
  journal      = {LANCET},
  keyword      = {FISTULA,RISK-FACTORS,METAANALYSIS,MANAGEMENT,MORBIDITY,MORTALITY,LEAK},
  language     = {eng},
  number       = {9776},
  pages        = {1514--1522},
  title        = {Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial},
  url          = {http://dx.doi.org/10.1016/S0140-6736(11)60237-7},
  volume       = {377},
  year         = {2011},
}

Chicago
Diener, Markus K, Christoph M Seiler, Inga Rossion, Joerg Kleeff, Matthias Glanemann, Giovanni Butturini, Ales Tomazic, et al. 2011. “Efficacy of Stapler Versus Hand-sewn Closure After Distal Pancreatectomy (DISPACT): a Randomised, Controlled Multicentre Trial.” Lancet 377 (9776): 1514–1522.
APA
Diener, M. K., Seiler, C. M., Rossion, I., Kleeff, J., Glanemann, M., Butturini, G., Tomazic, A., et al. (2011). Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. LANCET, 377(9776), 1514–1522.
Vancouver
1.
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(9776):1514–22.
MLA
Diener, Markus K, Christoph M Seiler, Inga Rossion, et al. “Efficacy of Stapler Versus Hand-sewn Closure After Distal Pancreatectomy (DISPACT): a Randomised, Controlled Multicentre Trial.” LANCET 377.9776 (2011): 1514–1522. Print.