Benign Liver Disease, Biliary Tract Diseases, Cholangiocarcinoma, Gallbladder Carcinoma, Hepatobiliary Diseases, Hepatocellular Carcinoma, Liver Metastases, Liver Metastases From Colorectal Cancer, Liver Neoplasms
Conditions
Keywords
Hepatobiliary surgery, Liver resection, Biliary resection, Hepatectomy, Postoperative complications, Postoperative mortality, Clavien-Dindo classification, Overall survival, Disease-free survival, Surgical outcomes, Observational study, Ambispective cohort, CRLM, HCC, Cholangiocarcinoma
Brief summary
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: * undergo standard surgical and perioperative management according to routine clinical practice * have clinical, surgical, and follow-up data collected from institutional medical records * be followed for postoperative outcomes and long-term oncologic outcomes up to 5 years
Detailed description
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.
Interventions
None listed
Sponsors
Azienda USL Toscana Centro
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Patients undergoing liver resection and/or biliary resection at San Jacopo Hospital, Pistoia * Diagnosis of benign or malignant hepatobiliary disease * Availability of clinical, surgical, and follow-up data * For the prospective cohort, provision of written informed consent when required according to local regulations
Exclusion criteria
* Age \< 18 years * Pregnancy * No liver or biliary resection performed * Biopsy only without resection * Refusal or unavailability of consent for the prospective cohort when consent is required
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative morbidity at 30 days | Within 30 days after surgery | Postoperative complications classified according to the Clavien-Dindo classification |
| Postoperative mortality at 30 days | Within 30 days after surgery | All-cause mortality after liver and/or biliary resection |
| Postoperative morbidity at 90 days | Within 90 days after surgery | Postoperative complications classified according to the Clavien-Dindo classification |
| Postoperative mortality at 90 days | Within 90 days after surgery | All-cause mortality after liver and/or biliary resection |
| Overall survival (OS) | Up to 5 years after surgery | Time from surgery to death from any cause in patients with malignant disease |
| Disease-free survival (DFS) | Up to 5 years after surgery | Time from surgery to disease recurrence or death in patients with malignant disease |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe postoperative complications | Within 90 days after surgery | Postoperative complications of Clavien-Dindo grade III or higher |
| Local and distant recurrence rate | Up to 5 years after surgery | Occurrence of local or distant recurrence in patients with malignant disease |
| Outcomes according to surgical approach | Within 90 days after surgery and up to 5 years after surgery | Comparison of outcomes according to surgical approach and extent of resection |
| Impact of preoperative risk factors | Within 90 days after surgery and up to 5 years after surgery | Association of preoperative clinical variables with postoperative and oncologic outcomes |
| Temporal trends and learning curve | From January 1, 2015 through December 31, 2036 | Assessment of temporal changes in clinical outcomes over the study period |
Countries
Italy
Contacts
CONTACTRosita De Vincenti, MD
PRINCIPAL_INVESTIGATORRosita De Vincenti
Azienda USL Toscana Centro
STUDY_CHAIRMassimo Fedi, MD
Azienda USL Toscana Centro
Outcome results
None listed