Abstract
In press
Background. Failure of biliary-digestive anastomoses with the development of bile extravasation remains a critical surgical complication associated with a high level of septic conditions and mortality. The lack of objective criteria for early differentiation of the severity of bile leakage necessitates the implementation of prognostic models to objectify surgical decision-making.
Aim. Development of a multifactorial mathematical model and clinical algorithm for early identification of the risk of progression of biliary extravasation in order to optimize the treatment strategy.
Materials and Methods. The results of treatment of 120 patients were analyzed by assessing diagnostic parameters, including the level of interleukin-6, the bilirubin gradient in the exudate, and the anatomical features of the biliary tree. Mathematical modeling and validation of the results were implemented using logistic regression analysis, construction of sigmoidal probability curves, and the bootstrap validation method with SPSS v.26.0 (IBM, USA). The work is a fragment of the research work of the Department of Surgery No.1 of the Kharkiv National Medical University "Development of diagnostic methods and open and minimally invasive technologies for the treatment of diseases and injuries of the thoracic and abdominal organs, vessels of the extremities in patients during wartime" (2024–2028), state registration number 0124U002908.
Research Ethics. The study was conducted in accordance with the main provisions of the Declaration of Helsinki of the World Medical Association (1964–2024). All patients signed a written informed consent for participation and processing of personal data.
Results. Key predictors of bile leak risk were identified, namely: anastomotic re-reconstruction, high strictures, hyperbilirubinemia > 100 μmol/l and hypoalbuminemia. The developed model demonstrated high predictive ability (AUC 0.94; sensitivity 89.3%; specificity 85.7%). The implementation of a three-stage algorithm allowed us to clearly distinguish treatment tactics between conservative management, minimally invasive decompression at an average risk level and urgent relaparotomy with the formation of a "guided fistula" at a high risk level.
Conclusions. The implementation of a three-level risk stratification system provided an objective choice between conservative tactics, minimally invasive interventions and relaparotomy. The use of interventional radiological techniques allowed us to avoid repeated operations and significantly improve treatment outcomes.
Keywords: surgery, biliodigestive anastomosis, bile leak, prognosis, minimally invasive interventions.
References
Dong CC, Jiang XJ, Shi XY, Li B, Chen L. Risk factors for bile duct injury after laparoscopic cholecystectomy: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2021;100(49):e28191. DOI: 10.1097/MD.0000000000028191. PMID: 34889299.
Burns R, Connor KL, Guest VR, Johnston CC, Harrison EM, Wigmore SJ, et al. Risk factors and mitigating measures associated with bile duct injury during cholecystectomy: meta-analysis. BJS Open. 2025;9(4):zraf076. DOI: 10.1093/bjsopen/zraf076. PMID: 40751483.
Brunner M, Grützmann R. [Biliodigestive anastomosis: technique and outcome]. Chirurgie (Heidelberg, Germany). 2025;96(11):925-33. DOI: 10.1007/s00104-025-02372-2. PMID: 40924083.
Schertz PJ, Mao CA, Derrick KD, Galar F, Ortiz CB, Bhambhvani AM, Hohenwalter EJ. Biliary leaks: multidisciplinary approach to diagnosis and treatment. Radiographics. 2024;44(1):e230155. DOI: 10.1148/rg.230155. PMID: 38935550.
Koch M, Garden OJ, Padbury R, Rahbari NN, Adam R, Capussotti L, et al. Bile leakage after hepatobiliary and pancreatic surgery: a definition and grading of severity by the International Study Group of Liver Surgery. Surgery. 2011;149(5):680-8. DOI: 10.1016/j.surg.2010.12.002. PMID: 21316725.
Zhao J, Zhang T, Deng Z, Han X, Ma T, Xie K. Evaluation of biomarkers from peritoneal fluid as predictors of severity for abdominal sepsis patients following emergency laparotomy. J Inflamm Res. 2023;16:809-26. DOI: 10.2147/JIR.S401428. PMID: 36876154.
Kofler A, Trattner M, Mairinger V, Urban I, Søreide K, Stättner S, et al. The role of perioperative interleukin-6 serum levels on liver dysfunction and infectious complications after hepatectomy – a systematic review. Cancers (Basel). 2025;17(19):3120. DOI: 10.3390/cancers17193120. PMID: 41097648.
Tan L, Liu F, Liu ZL, Xiao JW. Meta-Analysis of Risk Factors for Bile Leakage After Hepatectomy Without Biliary Reconstruction. Front Surg. 2021;8:764211. DOI: 10.3389/fsurg.2021.764211. PMID: 34790696.
Quintini D, Rizzo GEM, Tarantino I, Sarzo G, Fantin A, Miraglia R, et al. Endoscopic or combined management of post-surgical biliary leaks: a two-center recent experience. Surg Endosc. 2024;38(12):7233-42. DOI: 10.1007/s00464-024-11243-6. PMID: 39384654.
Mehrabi A, Abbasi Dezfouli S, Schlösser F, Ramouz A, Khajeh E, Ali-Hasan-Al-Saegh S, et al. Validation of the ISGLS classification of bile leakage after pancreatic surgery: A rare but severe complication. Eur J Surg Oncol. 2022;48(12):2440-7. DOI: 10.1016/j.ejso.2022.06.030. PMID: 35842371.
Rahbari NN, Elbers H, Koch M, Kirchberg J, Dutlu M, Mehrabi A, et al. Bilirubin level in the drainage fluid is an early and independent predictor of clinically relevant bile leakage after hepatic resection. Surgery. 2012;152(5):821-31. DOI: 10.1016/j.surg.2012.03.012. PMID: 22657729.
Liu R, Cai Y, Cai H, Lan Y, Meng L, Li Y, Peng B. Dynamic prediction for clinically relevant pancreatic fistula: a novel prediction model for laparoscopic pancreaticoduodenectomy. BMC Surg. 2021;21(1):7. DOI: 10.1186/s12893-020-00968-5. PMID: 33397337.
Li Z, Pan W, Xu G, Chen Z, Zhang L, Zheng Z, et al. Endoscopic management of biliary leakage after hepatectomy and analysis of its influencing factors. Ther Adv Gastrointest Endosc. 2025;18:26317745251388159. DOI: 10.1177/26317745251388159. PMID: 41181855.
Zhong WD, Hu G, Feng ZH, Shen WD, Shao GY. Endoluminal Vacuum-Assisted Closure Therapy for Upper Gastrointestinal Leak, Perforation, and Fistula: A Case Series and Literature Review. Dig Dis. 2023;41(3):506-12. DOI: 10.1159/000526713. PMID: 36288720.

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
