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NCT Number: NCT07556835

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

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Postoperative morbidity at 30 days

    Time frame: Within 30 days after surgery

    Postoperative complications classified according to the Clavien-Dindo classification

  2. Postoperative mortality at 30 days

    Time frame: Within 30 days after surgery

    All-cause mortality after liver and/or biliary resection

  3. Postoperative morbidity at 90 days

    Time frame: Within 90 days after surgery

    Postoperative complications classified according to the Clavien-Dindo classification

  4. Postoperative mortality at 90 days

    Time frame: Within 90 days after surgery

    All-cause mortality after liver and/or biliary resection

  5. Overall survival (OS)

    Time frame: Up to 5 years after surgery

    Time from surgery to death from any cause in patients with malignant disease

  6. 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

Secondary outcomes

  1. Severe postoperative complications

    Time frame: Within 90 days after surgery

    Postoperative complications of Clavien-Dindo grade III or higher

  2. Local and distant recurrence rate

    Time frame: Up to 5 years after surgery

    Occurrence of local or distant recurrence in patients with malignant disease

  3. 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

  4. 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

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Rosita De Vincenti, MD

CONTACT

[email protected]

+39 3204765618

Sponsors and collaborators

Lead sponsor

Azienda USL Toscana Centro

Other

Registry information

Official study title

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

Acronym: BILIVER

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

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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