title: The effect of prophylactic transpapillary pancreatic stent insertion on clinically significant leak rate following distal pancreatectomy: results of a prospective controlled clinical trial.
abstract: OBJECTIVE
  To determine whether prophylactic pancreatic duct stenting reduces pancreatic fistula (PF) formation after distal pancreatectomy (DP).
  
  
  BACKGROUND
  PF causes major morbidity after DP. Transpapillary pancreatic stenting has been proposed to be beneficial in treating established PF and also, prophylactically, to reduce the risk for PF after DP.
  
  
  METHODS
  Patients scheduled for DP during October 2006 to December 2010 were assessed and, if eligible, randomized to DP without (DP) or with stenting before transection of the neck of the gland (DP + stent). DP procedure was standardized and the follow-up period included the first 30 postoperative days. The outcomes were assessed according to the intention to treat analysis principle.
  
  
  RESULTS
  : Sixty-four patients were assessed and 58 were randomized to either DP (n = 29) or DP + stent (n = 29). Mean ± SD operation time for DP was 218.8 ± 94.1 compared to 283.3 ± 131.9 for DP + stent (P = 0.052). Clinically significant PF (ISGPF [The International Study Group on Pancreatic Fistula] classification Grade B or C) occurred in 6 DP (22.2%) and 11 (42.3%) DP + stent patients (odds ratio: 2.57, 95% confidence interval 0.78-8.48; P = 0.122). The mean hospital stay for patients without stent was 13.4 ± 6.4 days compared to 19.4 ± 14.4 days for those provided with a pancreatic stent (P = 0.071).
  
  
  CONCLUSIONS
  The results from this trial show that prophylactic pancreatic stenting does not reduce PF when performing a standardized resection of the body and tail of the pancreas. The trial was registered at clinicaltrials.gov NCT00500968.
authors.affiliation: Department of Clinical Science and Education, Karolinska Institutet, Department of Surgery, Södersjukhuset, Stockholm, Sweden. farshad.frozanpor@ki.se
authors.forename: Farshad
authors.initials: F
authors.lastname: Frozanpor
authors.forename: Lars
authors.initials: L
authors.lastname: Lundell
authors.forename: Ralf
authors.initials: R
authors.lastname: Segersvärd
authors.forename: Urban
authors.initials: U
authors.lastname: Arnelo
mesh_terms: D000368:Aged; D057868:Anastomotic Leak / Q000517:prevention & control*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010180:Pancreatectomy / Q000009:adverse effects*; D010182:Pancreatic Diseases / Q000601:surgery; D010183:Pancreatic Ducts; D010185:Pancreatic Fistula / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D019919:Prosthesis Implantation; D015607:Stents