San Jacopo Hospital
Pistoia, Tuscany, 51100, Italy
NCT Number: NCT07556835
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
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Pistoia, Tuscany, 51100, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Within 30 days after surgery
Postoperative complications classified according to the Clavien-Dindo classification
Time frame: Within 30 days after surgery
All-cause mortality after liver and/or biliary resection
Time frame: Within 90 days after surgery
Postoperative complications classified according to the Clavien-Dindo classification
Time frame: Within 90 days after surgery
All-cause mortality after liver and/or biliary resection
Time frame: Up to 5 years after surgery
Time from surgery to death from any cause in patients with malignant disease
Time frame: Up to 5 years after surgery
Time from surgery to disease recurrence or death in patients with malignant disease
Time frame: Within 90 days after surgery
Postoperative complications of Clavien-Dindo grade III or higher
Time frame: Up to 5 years after surgery
Occurrence of local or distant recurrence in patients with malignant disease
Time frame: Within 90 days after surgery and up to 5 years after surgery
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
Association of preoperative clinical variables with postoperative and oncologic outcomes
Time frame: From January 1, 2015 through December 31, 2036
Assessment of temporal changes in clinical outcomes over the study period
Contact information is provided by the study sponsor or research team.
Azienda USL Toscana Centro
Other
Ambispective Cohort Study of Clinical and Oncologic Outcomes in Patients Undergoing Liver and Biliary Resection at San Jacopo Hospital, Pistoia
Acronym: BILIVER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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