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Annals of Surgery:
doi: 10.1097/SLA.0b013e318251610f
Randomized Controlled Trial

The Effect of Prophylactic Transpapillary Pancreatic Stent Insertion on Clinically Significant Leak Rate Following Distal Pancreatectomy: Results of a Prospective Controlled Clinical Trial

Frozanpor, Farshad MD, PhD*,†; Lundell, Lars PhD; Segersvärd, Ralf PhD; Arnelo, Urban PhD

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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.

Patients and 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.

© 2012 Lippincott Williams & Wilkins, Inc.

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