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
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
San Jacopo Hospital
Pistoia, Tuscany, Italy
Postoperative morbidity at 30 days
Postoperative complications classified according to the Clavien-Dindo classification
Time frame: Within 30 days after surgery
Postoperative mortality at 30 days
All-cause mortality after liver and/or biliary resection
Time frame: Within 30 days after surgery
Postoperative morbidity at 90 days
Postoperative complications classified according to the Clavien-Dindo classification
Time frame: Within 90 days after surgery
Postoperative mortality at 90 days
All-cause mortality after liver and/or biliary resection
Time frame: Within 90 days after surgery
Overall survival (OS)
Time from surgery to death from any cause in patients with malignant disease
Time frame: Up to 5 years after surgery
Disease-free survival (DFS)
Time from surgery to disease recurrence or death in patients with malignant disease
Time frame: Up to 5 years after surgery
Severe postoperative complications
Postoperative complications of Clavien-Dindo grade III or higher
Time frame: Within 90 days after surgery
Local and distant recurrence rate
Occurrence of local or distant recurrence in patients with malignant disease
Time frame: Up to 5 years after surgery
Outcomes according to surgical approach
Comparison of outcomes according to surgical approach and extent of resection
Time frame: 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
Time frame: 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
Time frame: From January 1, 2015 through December 31, 2036
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