External Drainage of Pancreatic Duct With a Stent to Reduce Leakage Rate of Pancreaticojejunostomy After Pancreaticoduodenectomy: A Prospective Randomized Trial

Pancreaticoduodenectomy is the treatment of choice for patients with resectable carcinoma of the pancreatic head and periampullary region. In recent years, mortality rate of pancreaticoduodenectomy has declined to <5% in many institutions around the world.1–4 However, pancreatic fistula still occurs in 5% to 40% of patients after pancreaticoduodenectomy, depending on the definition of leakage.5–8 The reduction in operative mortality over the past few decades has not been accompanied by a notable improvement of pancreatic fistula rate.9 Hence, it is imperative to conduct research to identify effective strategies to reduce pancreatic leakage after pancreaticoduodenectomy.10 Currently, there is no consensus on the best way of managing the pancreatic stump after pancreaticoduodenectomy. Pancreaticojejunal (PJ) anastomosis is the classic method of reconstruction. Technical modifications such as pancreatic duct occlusion, reinforcement of anastomosis with fibrin glue, placement of internal stent, and pancreaticogastrostomy do not seem to improve the results in prospective randomized trials.10–14 Octreotide has been used to reduce the incidence of pancreatic fistula, but its efficacy remains controversial due to inconsistent results in prospective randomized trials.5,8,15–17 A meta-analysis did not find a benefit of Octreotide in patients undergoing pancreaticoduodenectomy.10 Some retrospective studies have reported low pancreatic fistula rate with the use of a catheter inserted into the pancreatic duct for external drainage of pancreatic jucie.18,19 By diverting away pancreatic juice from the anastomosis, it could theoretically reduce the incidence of PJ anastomotic leakage. A recent prospective but nonrandomized study showed that external drainage of the pancreatic duct decreased the rate of pancreatic fistula from 29.3% to 6.8%, and reduced the median hospital stay from 29 to 13 days.6 Thus far, no prospective randomized trial on the use of external drainage stent for pancreatic anastomosis has been reported. We conducted a prospective randomized trial to test the hypothesis that external drainage of pancreatic duct with a stent could decrease the rate of pancreatic fistula after pancreaticoduodenectomy with PJ anastomosis.