Shark mouth pancreaticojejunostomy reduced the rate of clinically related pancreatic fistula: a historic cohort comparative analysis.

BACKGROUND: A novel procedure called shark mouth pancreaticojejunostomy (SMP) was developed, for the reconstruction of the pancreatic stump which has a theoretical advantage for anastomosis healing and wide applicability. METHODS: A comparative study of the patients who underwent SMP (SMP cohort) and those who underwent end-to-end dunking pancreaticojejunostomy (historic cohort) at Peking University Third Hospital was conducted. Each group was analyzed for the incidence of clinically relevant postoperative pancreatic fistula (CR-POPF) and morbidities. RESULTS: The clinicopathological data of 151 patients from the SMP cohort and 82 patients from the historic cohort were analyzed. In the SMP group, the rate of CR-POPF was 7.3% (11/151), which was significantly lower than the rate of CR-POPF in the historic group as 19.5% (16/82) (P = 0.005). The primary results were unaffected by sensitivity analyses based on several risk factors for CR-POPF. The rates of morbidities besides CR-POPF were 15.9% (24/151) in the SMP group and 17.1% (14/82) in the historic cohort (P = 0.194). The principal results were not changed by the propensity score matched (PSM) analysis. CONCLUSION: SMP is a safe and simple surgical procedure for the reconstruction of the pancreatic stump compared with end-to-end dunking pancreticojejunostomy.

Shark mouth pancreaticojejunostomy: a new enteric reconstruction procedure of pancreatic stump.

BACKGROUND: The enteric reconstruction procedure of pancreatic stump after pancreaticoduodenectomy remains to be the critical factor influencing the mortality and morbidity. No widely accepted surgical procedure for the pancreaticojejunostomy has been erected yet. We have developed a new technique of pancreaticojejunostomy named "shark mouth pancreaticojejunostomy." The aim of this study is to assess the efficacy of "shark mouth pancreaticojejunostomy." METHODS: This is a prospective single-arm observational study to evaluate the clinical efficacy of "shark mouth pancreaticojejunostomy." Patients with diseases, in whom a pancreaticoduodenectomy is indicated, would be recruited from Peking University Third Hospital. The hypothesis to be tested is that a "shark mouth pancreaticojejunostomy" will reduce fistula rate from around 20% to less than 10%. A sample size of 120 patients will be needed. The primary endpoint is the incidence rate of postoperative pancreatic fistula (POPF). The secondary endpoints of the study are anastomosis time, postoperative hospital stay, and morbidities besides the POPF such as the hemorrhage. Enrolled patients will undergo pancreaticoduodenectomy and be followed up for 3 months. The relevant data will be monitored and recorded. CONCLUSIONS: The current trial will explore the therapeutic value of the newly raised pancreaticojejunostomy procedure as the "shark mouth pancreaticojejunostomy." Its theoretical base and pragmatic feature will promise high external validity. TRIAL REGISTRATION: Clinical Trials.gov: NCT03366038; https://www.clinicaltrials.gov.