A Novel End-to-End Biliary-to-Biliary Anastomosis Technique for Iatrogenic Bile Duct Injury of Strasberg-Bismuth E1-4 Treatment: A Retrospective Study and in vivo Assessment.

Background: An iatrogenic bile duct injury (IBDI) is a severe complication that has a great impact on the physical and mental quality of life of the patients, especially for patients with postoperative benign biliary stricture. The effective measures for end-to-end biliary-to-biliary anastomosis intraoperative are essential to prevent the postoperative bile duct stricture, but also a challenge even to the most skilled biliary tract surgeon. Objective: A postoperative benign biliary stricture is an extremely intractable complication that occurs following IBDI. This study aimed to introduce a novel end-to-end biliary-to-biliary anastomosis technique named fish-mouth-shaped (FMS) end-to-end biliary-to-biliary reconstruction and determine the safety and effectiveness for preventing the postoperative benign biliary stricture in both rats and humans. Methods: In this study, 18 patients with biliary injury who underwent an FMS reconstruction procedure were retrospectively analyzed. Their general information, disease of the first hospitalization, operation method, and classification of bile duct injury (BDI) were collected. The postoperative complications were evaluated immediately perioperatively and the long-term complications were followed up at the later period of at least 5 years. An IBDI animal model using 18 male rats was developed for animal-based evaluations. A bile duct diathermy injury model was used to mimic BDI. The FMS group underwent an FMS reconstruction procedure while the control group underwent common end-to-end biliary-to-biliary anastomosis, a sham operation group was also established. The blood samples, liver, spleen, and common bile duct tissues were harvested for further assessments. Results: In the retrospective study, there was no postoperative mortality and no patient developed cholangitis during the 5-years postoperation follow-up. In the study of IBDI animal models, compared with the control group, the FMS reconstruction procedure reduced the occurrence of benign biliary stenosis, liver function damage, and jaundice. The blood tests as well as morphological and pathological observations revealed that rats in the FMS reconstruction group had a better recovery than those in the control group. Conclusions: An FMS reconstruction procedure is a safe and efficient BDI treatment method.