Outcomes After Liver and Biliary Resection at a High-Volume Center (BILIVER)

April 22, 2026 updated by: Rosita De Vincenti, Azienda USL Toscana Centro

Ambispective Cohort Study of Clinical and Oncologic Outcomes in Patients Undergoing Liver and Biliary Resection at San Jacopo Hospital, Pistoia

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

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative morbidity at 30 days
Time Frame: Within 30 days after surgery
Postoperative complications classified according to the Clavien-Dindo classification
Within 30 days after surgery
Postoperative mortality at 30 days
Time Frame: Within 30 days after surgery
All-cause mortality after liver and/or biliary resection
Within 30 days after surgery
Postoperative morbidity at 90 days
Time Frame: Within 90 days after surgery
Postoperative complications classified according to the Clavien-Dindo classification
Within 90 days after surgery
Postoperative mortality at 90 days
Time Frame: Within 90 days after surgery
All-cause mortality after liver and/or biliary resection
Within 90 days after surgery
Overall survival (OS)
Time Frame: Up to 5 years after surgery
Time from surgery to death from any cause in patients with malignant disease
Up to 5 years after surgery
Disease-free survival (DFS)
Time Frame: Up to 5 years after surgery
Time from surgery to disease recurrence or death in patients with malignant disease
Up to 5 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe postoperative complications
Time Frame: Within 90 days after surgery
Postoperative complications of Clavien-Dindo grade III or higher
Within 90 days after surgery
Local and distant recurrence rate
Time Frame: Up to 5 years after surgery
Occurrence of local or distant recurrence in patients with malignant disease
Up to 5 years after surgery
Outcomes according to surgical approach
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
Within 90 days after surgery and up to 5 years after surgery
Impact of preoperative risk factors
Time Frame: Within 90 days after surgery and up to 5 years after surgery
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
Time Frame: From January 1, 2015 through December 31, 2036
Assessment of temporal changes in clinical outcomes over the study period
From January 1, 2015 through December 31, 2036

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda USL Toscana Centro

Investigators

  • Principal Investigator: Rosita De Vincenti, Azienda USL Toscana Centro
  • Study Chair: Massimo Fedi, MD, Azienda USL Toscana Centro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

January 1, 2036

Study Completion (Estimated)

December 1, 2036

Study Registration Dates

First Submitted

April 22, 2026

First Submitted That Met QC Criteria

April 22, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BILIVER
  • BILIVER Protocol v1.0 (Other Identifier: Azienda USL Toscana Centro)
  • 30307_OSS (Other Identifier: Area Vasta Centro Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe