An observational study in Liver Neoplasms, Hepatobiliary Diseases and Cholangiocarcinoma, sponsored by Azienda USL Toscana Centro. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Azienda USL Toscana Centro · Observational
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.
3,648 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,061 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 850 observational studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Azienda USL Toscana Centro is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Compared within Carcinoma, Hepatocellular, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Liver Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Plan to share: No — 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.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Azienda USL Toscana Centro