Jin Xu1, Bo Zhang1, Si Shi1, Yi Qin1, Shunrong Ji1, Wenyan Xu1, Jiang Liu1, Liang Liu1, Chen Liu1, Jiang Long1, Quanxing Ni1, Xianjun Yu2. 1. Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Pancreatic Cancer Institute, Fudan University, Shanghai, China. 2. Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai, China; Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China; Pancreatic Cancer Institute, Fudan University, Shanghai, China. Electronic address: yuxianjun88@hotmail.com.
Abstract
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.
RCT Entities:
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.
Authors: Marco V Marino; Adrian Kah Heng Chiow; Antonello Mirabella; Gianpaolo Vaccarella; Andrzej L Komorowski Journal: J Clin Med Date: 2021-05-18 Impact factor: 4.241