title: Stapler versus scalpel resection followed by hand-sewn closure of the pancreatic remnant for distal pancreatectomy.
abstract: BACKGROUND
  Resections of the pancreatic body and tail reaching to the left of the superior mesenteric vein are defined as distal pancreatectomy. Most distal pancreatectomies are elective treatments for chronic pancreatitis, benign or malignant diseases, and they have high morbidity rates of up to 40%. Pancreatic fistula formation is the main source of postoperative morbidity, associated with numerous further complications. Researchers have proposed several surgical resection and closure techniques of the pancreatic remnant in an attempt to reduce these complications. The two most common techniques are scalpel resection followed by hand-sewn closure of the pancreatic remnant and stapler resection and closure.
  
  
  OBJECTIVE
  To compare the rates of pancreatic fistula in people undergoing distal pancreatectomy using scalpel resection followed by hand-sewn closure of the pancreatic remnant versus stapler resection and closure.
  
  
  METHODS
  We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, Biosis and Science Citation Index from database inception to October 2015.
  
  
  METHODS
  We included randomised controlled trials (RCTs) comparing stapler versus scalpel resection followed by hand-sewn closure of the pancreatic remnant for distal pancreatectomy (irrespective of language or publication status).
  
  
  METHODS
  Two authors independently assessed trials for inclusion and extracted the data. Taking into consideration the clinical heterogeneity between the trials (e.g. different endpoint definitions), we analysed data using a random-effects model with Review Manager (RevMan), calculating risk ratio (RR) or mean difference (MD) with 95% confidence intervals (CI).
  
  
  RESULTS
  In two eligible trials, a total of 381 participants underwent distal pancreatic resection and were randomised to closure of the pancreatic remnant either with stapler (n = 191) or scalpel resection followed by hand-sewn closure (n = 190). One was a single centre pilot RCT and the other was a multicentre blinded RCT. The single centre pilot RCT evaluated 69 participants in five intervention arms (stapler, hand-sewn, fibrin glue, mesh and pancreaticojejunostomy), although we only assessed the stapler and hand-sewn closure groups (14 and 15 participants, respectively). The multicentre RCT had two interventional arms: stapler (n = 177) and hand-sewn closure (n = 175). The rate of postoperative pancreatic fistula was the main outcome, and it occurred in 79 of 190 participants in the hand-sewn group compared to 65 of 191 participants in the stapler group. Neither the individual trials nor the meta-analysis showed a significant difference between resection techniques (RR 0.90; 95% CI 0.55 to 1.45; P = 0.66). In the same way, postoperative mortality and operation time did not differ significantly. The single centre RCT had an unclear risk of bias in the randomisation, allocation and both blinding domains. However, the much larger multicentre RCT had a low risk of bias in all domains. Due to the small number of events and the wide confidence intervals that cannot exclude clinically important benefit or harm with stapler versus hand-sewn closure, there is a serious possibility of imprecision, making the overall quality of evidence moderate.
  
  
  CONCLUSIONS
  The quality of evidence is moderate and mainly based on the high weight of the results of one multicentre RCT. Unfortunately, there are no other completed RCTs on this topic except for one relevant ongoing trial. Neither stapler nor scalpel resection followed by hand-sewn closure of the pancreatic remnant for distal pancreatectomy showed any benefit compared to the other method in terms of postoperative pancreatic fistula, overall postoperative mortality or operation time. Currently, the choice of closure is left up to the preference of the individual surgeon and the anatomical characteristics of the patient. Another (non-European) multicentre trial (e.g. with an equality or non-inferiority design) would help to corroborate the findings of this meta-analysis. Future trials assessing novel methods of stump closure should compare them either with stapler or hand-sewn closure as a control group to ensure comparability of results.
authors.affiliation: Department of General, Visceral and Transplant Surgery, University of Heidelberg, Im Neuenheimer Feld 110, Heidelberg, Germany, D-69120.
authors.forename: Pascal
authors.initials: P
authors.lastname: Probst
authors.forename: Felix J
authors.initials: FJ
authors.lastname: Hüttner
authors.forename: Ulla
authors.initials: U
authors.lastname: Klaiber
authors.forename: Phillip
authors.initials: P
authors.lastname: Knebel
authors.forename: Alexis
authors.initials: A
authors.lastname: Ulrich
authors.forename: Markus W
authors.initials: MW
authors.lastname: Büchler
authors.forename: Markus K
authors.initials: MK
authors.lastname: Diener
mesh_terms: D015718:Fibrin Tissue Adhesive; D006801:Humans; D061646:Operative Time; D010179:Pancreas / Q000601:surgery*; D010180:Pancreatectomy / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D010185:Pancreatic Fistula / Q000453:epidemiology / Q000209:etiology; D016032:Randomized Controlled Trials as Topic; D013525:Surgical Instruments; D013526:Surgical Mesh; D013528:Surgical Staplers; D013536:Suture Techniques
chemical_list: D015718:Fibrin Tissue Adhesive