Background: Development of a postoperative pancreatic fistula (POPF) is the single most significant complication of pancreatic anastomosis, which is a key procedure in pancreaticoduodenectomy. We previously reported a new papillary-like pancreaticojejunostomy, and a retrospective study showed a benefit in reducing the incidence of grade B/C POPF compared with duct-to-mucosa pancreaticojejunostomy. The aim of this study was to reassess whether the new pancreaticojejunostomy would decrease the POPF rate.
Methods: A prospective, randomized, controlled trial (NCT01731821 registered at http://ClinicalTrials.gov) involving 308 patients who underwent pancreaticoduodenectomy was conducted.
Results: The overall POPF rate was significantly lower in the papillary-like group compared with the duct-to-mucosa group (14/155 [9.0%] vs 31/153 [20.3%]; P = .005), and the grade B/C POPF rate of the papillary-like group was significantly decreased compared with the duct-to-mucosa group. Multivariable analyses identified higher body mass index (odds ratio [OR], 3.520; P = .000), longer operative time (OR, 2.587; P = .041), soft texture and nondilated main pancreatic duct (OR, 0.365; P = .014), and the duct-to-mucosa pancreaticojejunostomy (OR, 0.405; P = .013) as significant risk factors for POPF. Further stratified analyses showed that, for patients with soft texture and nondilated main pancreatic duct, the POPF rate in the papillary-like group (9.6%) was significantly lower than that in the duct-to-mucosa group (27.3%). However, for patients with hard texture or dilated main pancreatic duct, there was no difference between the 2 groups (7.8% vs 8.6%; P > 0.999).
Conclusion: The new papillary-like pancreaticojejunostomy may provide a better option for patients with soft texture and nondilated main pancreatic duct.
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