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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda USL Toscana Centro

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age < 18 years

Pregnancy

No liver or biliary resection performed

Biopsy only without resection

Trial 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).

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Postoperative morbidity at 30 days

Postoperative complications classified according to the Clavien-Dindo classification

Time frame
Within 30 days after surgery
2

Postoperative mortality at 30 days

All-cause mortality after liver and/or biliary resection

Time frame
Within 30 days after surgery
3

Postoperative morbidity at 90 days

Postoperative complications classified according to the Clavien-Dindo classification

Time frame
Within 90 days after surgery
4

Postoperative mortality at 90 days

All-cause mortality after liver and/or biliary resection

Time frame
Within 90 days after surgery

Secondary outcomes

1

Severe postoperative complications

Postoperative complications of Clavien-Dindo grade III or higher

Time frame
Within 90 days after surgery
2

Local and distant recurrence rate

Occurrence of local or distant recurrence in patients with malignant disease

Time frame
Up to 5 years after surgery
3

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
4

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: