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

Abstract

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.

Figure 1

The procedure of “shark mouth pancreaticojejunostomy.” (A) The jujunum remnant and the pancreatic stump. (B) The posterior seromuscular layer suture. (C) The posterior full thickness layer suture and internal silicone tube is inserted as the stent tube. (D) The anterior full thickness layer suture. (E) The seromuscular layer of the proximal jejunum is sutured with the anterior pancreatic capsule to cover the anterior part of anastomosis. (F) The schematic map of the “shark mouth pancreaticojejunostomy”.

Figure 2

The operative photograph of “shark mouth pancreaticojejunostomy.” (A) The posterior seromuscular layer and full thickness layer suture. (B) The anterior full thickness layer suture. (C) The closure of “shark mouth pancreaticojejunostomy.”