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| ID | Type | Description | Link |
|---|---|---|---|
| BILIVER Protocol v1.0 | Other Identifier | Azienda USL Toscana Centro | |
| 30307_OSS | Other Identifier | Area Vasta Centro Ethics Committee |
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The goal of this observational study is to evaluate clinical and oncologic outcomes in adult patients undergoing liver and/or biliary resection for benign and malignant diseases.
This study evaluates postoperative morbidity and mortality within 90 days after surgery, as well as overall survival and disease-free survival in patients with malignant disease.
Participants will:
Hepatobiliary surgery is associated with significant postoperative morbidity and mortality, particularly in patients undergoing liver and/or biliary resection for benign and malignant diseases. Despite advances in surgical techniques, perioperative care, and patient selection, outcomes remain variable and influenced by multiple clinical and technical factors.
This is a monocentric ambispective observational cohort study conducted at a high-volume hepatobiliary center. The study includes a retrospective cohort of patients treated between January 1, 2015 and December 31, 2025, and a prospective cohort of patients treated between January 1, 2026 and December 31, 2031. Clinical and oncologic follow-up will continue until December 31, 2036.
The study aims to evaluate short-term and long-term outcomes after liver and/or biliary resection. Primary outcomes include postoperative morbidity and mortality within 90 days after surgery, as well as overall survival and disease-free survival in patients with malignant disease.
Secondary objectives include the identification of predictors of postoperative complications, evaluation of recurrence patterns, comparison of outcomes according to surgical approach and extent of resection, and assessment of the impact of preoperative risk factors and temporal trends.
Data will be collected from electronic medical records, operative reports, radiological and pathological data, and institutional databases. Adult patients undergoing liver and/or biliary resection for benign or malignant diseases will be included according to predefined eligibility criteria.
No study-specific interventions are assigned. All patients will receive standard clinical care according to routine practice. Follow-up data will be collected at predefined intervals, including early postoperative outcomes and long-term oncologic outcomes up to 5 years after surgery.
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| Measure | Description | Time Frame |
|---|---|---|
| Postoperative morbidity at 30 days | Postoperative complications classified according to the Clavien-Dindo classification | Within 30 days after surgery |
| Postoperative mortality at 30 days | All-cause mortality after liver and/or biliary resection | Within 30 days after surgery |
| Postoperative morbidity at 90 days | Postoperative complications classified according to the Clavien-Dindo classification | Within 90 days after surgery |
| Postoperative mortality at 90 days | All-cause mortality after liver and/or biliary resection | Within 90 days after surgery |
| Overall survival (OS) | Time from surgery to death from any cause in patients with malignant disease | Up to 5 years after surgery |
| Disease-free survival (DFS) | Time from surgery to disease recurrence or death in patients with malignant disease | Up to 5 years after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Severe postoperative complications | Postoperative complications of Clavien-Dindo grade III or higher | Within 90 days after surgery |
| Local and distant recurrence rate | Occurrence of local or distant recurrence in patients with malignant disease |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing liver and/or biliary resection for benign or malignant hepatobiliary diseases at San Jacopo Hospital, Pistoia, a high-volume hepatobiliary center. The study includes both a retrospective cohort (2015-2025) and a prospective cohort (2026-2031).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosita De Vincenti, MD | Contact | +39 3204765618 | rosita.devincenti@uslcentro.toscana.it |
| Name | Affiliation | Role |
|---|---|---|
| Rosita De Vincenti | Azienda USL Toscana Centro | Principal Investigator |
| Massimo Fedi, MD | Azienda USL Toscana Centro | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Jacopo Hospital | Pistoia | Tuscany | 51100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35946822 | Background | Gorgec B, Benedetti Cacciaguerra A, Pawlik TM, Aldrighetti LA, Alseidi AA, Cillo U, Kokudo N, Geller DA, Wakabayashi G, Asbun HJ, Besselink MG, Cherqui D, Cheung TT, Clavien PA, Conrad C, D'Hondt M, Dagher I, Dervenis C, Devar J, Dixon E, Edwin B, Efanov M, Ettore GM, Ferrero A, Fondevilla C, Fuks D, Giuliante F, Han HS, Honda G, Imventarza O, Kooby DA, Lodge P, Lopez-Ben S, Machado MA, Marques HP, O'Rourke N, Pekolj J, Pinna AD, Portolani N, Primrose J, Rotellar F, Ruzzenente A, Schadde E, Siriwardena AK, Smadi S, Soubrane O, Tanabe KK, Teh CSC, Torzilli G, Van Gulik TM, Vivarelli M, Wigmore SJ, Abu Hilal M. An International Expert Delphi Consensus on Defining Textbook Outcome in Liver Surgery (TOLS). Ann Surg. 2023 May 1;277(5):821-828. doi: 10.1097/SLA.0000000000005668. Epub 2022 Aug 10. | |
| 35773091 |
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Individual participant data will not be publicly shared due to privacy and regulatory restrictions. De-identified data may be made available upon reasonable request to the corresponding investigator, subject to institutional approval.
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| Up to 5 years after surgery |
| Outcomes according to surgical approach | Comparison of outcomes according to surgical approach and extent of resection | Within 90 days after surgery and up to 5 years after surgery |
| Impact of preoperative risk factors | Association of preoperative clinical variables with postoperative and oncologic outcomes | Within 90 days after surgery and up to 5 years after surgery |
| Temporal trends and learning curve | Assessment of temporal changes in clinical outcomes over the study period | From January 1, 2015 through December 31, 2036 |
| Background |
| de Graaff MR, Elfrink AKE, Buis CI, Swijnenburg RJ, Erdmann JI, Kazemier G, Verhoef C, Mieog JSD, Derksen WJM, van den Boezem PB, Ayez N, Liem MSL, Leclercq WKG, Kuhlmann KFD, Marsman HA, van Duijvendijk P, Kok NFM, Klaase JM, Dejong CHC, Grunhagen DJ, den Dulk M; for Dutch Hepato Biliary Audit Group, Collaborators. Defining Textbook Outcome in liver surgery and assessment of hospital variation: A nationwide population-based study. Eur J Surg Oncol. 2022 Dec;48(12):2414-2423. doi: 10.1016/j.ejso.2022.06.012. Epub 2022 Jun 20. |
| 38985363 | Background | Nicolazzi M, Di Martino M, Baroffio P, Donadon M. 6,126 hepatectomies in 2022: current trend of outcome in Italy. Langenbecks Arch Surg. 2024 Jul 10;409(1):211. doi: 10.1007/s00423-024-03398-6. |
| 38214817 | Background | Alaimo L, Endo Y, Catalano G, Ruzzenente A, Aldrighetti L, Weiss M, Bauer TW, Alexandrescu S, Poultsides GA, Maithel SK, Marques HP, Martel G, Pulitano C, Shen F, Cauchy F, Koerkamp BG, Endo I, Kitago M, Pawlik TM. Benchmarks in Liver Resection for Intrahepatic Cholangiocarcinoma. Ann Surg Oncol. 2024 May;31(5):3043-3052. doi: 10.1245/s10434-023-14880-8. Epub 2024 Jan 12. |
| 40760319 | Background | Heil J, Sliwinski S, D'Haese J, Fangmann J, Farkas S, Grutzmann R, Glanemann M, Kalff JC, Mees ST, Mehrabi A, Michalski C, Pratschke J, Reissfelder C, Schmeding M, Schwarzbach M, Stavrou GA, Werner J, Klinger C, Buhr H, Bechstein WO, Schnitzbauer AA; DGAV StuDoQ-Registry. Textbook Outcome After Major Liver Resection for Primary and Secondary Liver Tumors at Specialized German Hepatobiliary Centers: Analysis of the StuDoQ Liver Registry. Ann Surg Oncol. 2025 Oct;32(10):7183-7194. doi: 10.1245/s10434-025-17866-w. Epub 2025 Aug 4. |
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D004066 | Digestive System Diseases |
| D018281 | Cholangiocarcinoma |
| D006528 | Carcinoma, Hepatocellular |
| D001660 | Biliary Tract Diseases |
| D005706 | Gallbladder Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008107 | Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D001661 | Biliary Tract Neoplasms |
| D005705 | Gallbladder Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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