External drainage of pancreatic duct with a stent to reduce leakage rate of pancreaticojejunostomy after pancreaticoduodenectomy: a prospective randomized trial

Abstract

Objective: Pancreatic fistula is a leading cause of morbidity and mortality after pancreaticoduodenectomy. External drainage of pancreatic duct with a stent has been shown to reduce pancreatic fistula rate of pancreaticojejunostomy in a few retrospective or prospective nonrandomized studies, but no randomized controlled trial has been reported thus far. This single-center prospective randomized trial compared the results of pancreaticoduodenectomy with external drainage stent versus no stent for pancreaticojejunal anastomosis.

Methods: A total of 120 patients undergoing pancreaticoduodenectomy with end-to-side pancreaticojejunal anastomosis were randomized to have either an external stent inserted across the anastomosis to drain the pancreatic duct (n = 60) or no stent (n = 60). Duct-to-mucosa anastomosis was performed in all cases.

Results: The 2 groups were comparable in demographic data, underlying pathologies, pancreatic consistency, and duct diameter. Stented group had a significantly lower pancreatic fistula rate compared with nonstented group (6.7% vs. 20%, P = 0.032). Radiologic or surgical intervention for pancreatic fistula was required in 1 patient in the stented group and 4 patients in the nonstented group. There were no significant differences in overall morbidity (31.7% vs. 38.3%, P = 0.444) and hospital mortality (1.7% vs. 5%, P = 0.309). Two patients in the nonstented group and none in the stented group died of pancreatic fistula. Hospital stay was significantly shorter in the stented group (mean 17 vs. 23 days, P = 0.039). On multivariate analysis, no stenting and pancreatic duct diameter <3 mm were significant risk factors of pancreatic fistula.

Conclusion: External drainage of pancreatic duct with a stent reduced leakage rate of pancreaticojejunostomy after pancreaticoduodenectomy.

FIGURE 1. A, Diagrammatic illustration of end-to-side, duct-to-mucosa pancreaticojejunostomy with an external pancreatic duct stent. The stent was inserted into the pancreatic duct after suturing the back layer of the duct-to-mucosa anastomosis, secured by suturing the catheter to the jejunal mucosa using an absorbable suture, and then the anterior layer of the anastomosis was completed. Only the portion of the catheter within the pancreatic duct had side holes. B, The stent was brought out via an enterotomy in the free end of the jejunal loop, then externalized through a stab incision of the anterior abdominal wall. The enterotomy site was closed with a purse-string suture, and the serosa around the enterotomy site was sutured to the peritoneum on each side to prevent spillage of intestinal content into the peritoneal cavity on removal of the stent.