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Liver NeoplasmsBILIVERNCT07556835

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

An observational study of Liver Neoplasms and Hepatobiliary Diseases, run by Azienda USL Toscana Centro at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,000 participants
Where
1 siteItaly
Study dates
Apr 2026to Dec 2036
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rosita De Vincenti, MD contact

+39 3204765618

rosita.devincenti@uslcentro.toscana.it

Italy1 site

  • San Jacopo Hospital

    Pistoia, Tuscany, 51100

    Rosita De Vincenti, MD, +39 3204765618, rosita.devincenti@uslcentro.toscana.it

Other trials in Italy

About this study

Official title: 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
Read the 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.

Keywords
Hepatobiliary surgery, Liver resection, Biliary resection, Hepatectomy, Postoperative complications, Postoperative mortality, Clavien-Dindo classification, Overall survival, Disease-free survival, Surgical outcomes, Observational study, Ambispective cohort, CRLM, HCC, Cholangiocarcinoma
Medical subject headings
Liver Neoplasms, Digestive System Diseases, Cholangiocarcinoma, Carcinoma, Hepatocellular, Biliary Tract Diseases, Gallbladder Neoplasms, Postoperative Complications

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative morbidity at 30 days

    Postoperative complications classified according to the Clavien-Dindo classification

    Measured: Within 30 days after surgery

  2. Postoperative mortality at 30 days

    All-cause mortality after liver and/or biliary resection

    Measured: Within 30 days after surgery

  3. Postoperative morbidity at 90 days

    Postoperative complications classified according to the Clavien-Dindo classification

    Measured: Within 90 days after surgery

  4. Postoperative mortality at 90 days

    All-cause mortality after liver and/or biliary resection

    Measured: Within 90 days after surgery

  5. Overall survival (OS)

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

    Measured: Up to 5 years after surgery

  6. Disease-free survival (DFS)

    Time from surgery to disease recurrence or death in patients with malignant disease

    Measured: Up to 5 years after surgery

Secondary outcomes (5)

  1. Severe postoperative complications

    Postoperative complications of Clavien-Dindo grade III or higher

    Measured: Within 90 days after surgery

  2. Local and distant recurrence rate

    Occurrence of local or distant recurrence in patients with malignant disease

    Measured: Up to 5 years after surgery

  3. Outcomes according to surgical approach

    Comparison of outcomes according to surgical approach and extent of resection

    Measured: 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

    Measured: Within 90 days after surgery and up to 5 years after surgery

  5. Temporal trends and learning curve

    Assessment of temporal changes in clinical outcomes over the study period

    Measured: From January 1, 2015 through December 31, 2036

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study startApr 2026 (estimated)
  3. Primary completionJan 2036 (estimated)
  4. Study completionDec 2036 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07556835
Sponsor's protocol ID
BILIVER
Other IDs
BILIVER Protocol v1.0, 30307_OSS
Acronym
BILIVER
Status last verified
Apr 2026
First submitted
22 Apr 2026
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Gorgec B, Benedetti Cacciaguerra A, Pawlik TM, Aldrighetti LA, Alseidi AA, Cillo U, Kokudo N, Geller DA, Wakabayashi G, Asbun HJ, Besselink MG, Cherqui D, Cheung TT, Clavien PA, Conrad C, D'Hondt M, Dagher I, Dervenis C, Devar J, Dixon E, Edwin B, Efanov M, Ettore GM, Ferrero A, Fondevilla C, Fuks D, Giuliante F, Han HS, Honda G, Imventarza O, Kooby DA, Lodge P, Lopez-Ben S, Machado MA, Marques HP, O'Rourke N, Pekolj J, Pinna AD, Portolani N, Primrose J, Rotellar F, Ruzzenente A, Schadde E, Siriwardena AK, Smadi S, Soubrane O, Tanabe KK, Teh CSC, Torzilli G, Van Gulik TM, Vivarelli M, Wigmore SJ, Abu Hilal M. An International Expert Delphi Consensus on Defining Textbook Outcome in Liver Surgery (TOLS). Ann Surg. 2023 May 1;277(5):821-828. doi: 10.1097/SLA.0000000000005668. Epub 2022 Aug 10.

    PubMed 35946822

  • de Graaff MR, Elfrink AKE, Buis CI, Swijnenburg RJ, Erdmann JI, Kazemier G, Verhoef C, Mieog JSD, Derksen WJM, van den Boezem PB, Ayez N, Liem MSL, Leclercq WKG, Kuhlmann KFD, Marsman HA, van Duijvendijk P, Kok NFM, Klaase JM, Dejong CHC, Grunhagen DJ, den Dulk M; for Dutch Hepato Biliary Audit Group, Collaborators. Defining Textbook Outcome in liver surgery and assessment of hospital variation: A nationwide population-based study. Eur J Surg Oncol. 2022 Dec;48(12):2414-2423. doi: 10.1016/j.ejso.2022.06.012. Epub 2022 Jun 20.

    PubMed 35773091

  • Nicolazzi M, Di Martino M, Baroffio P, Donadon M. 6,126 hepatectomies in 2022: current trend of outcome in Italy. Langenbecks Arch Surg. 2024 Jul 10;409(1):211. doi: 10.1007/s00423-024-03398-6.

    PubMed 38985363

  • Alaimo L, Endo Y, Catalano G, Ruzzenente A, Aldrighetti L, Weiss M, Bauer TW, Alexandrescu S, Poultsides GA, Maithel SK, Marques HP, Martel G, Pulitano C, Shen F, Cauchy F, Koerkamp BG, Endo I, Kitago M, Pawlik TM. Benchmarks in Liver Resection for Intrahepatic Cholangiocarcinoma. Ann Surg Oncol. 2024 May;31(5):3043-3052. doi: 10.1245/s10434-023-14880-8. Epub 2024 Jan 12.

    PubMed 38214817

  • Heil J, Sliwinski S, D'Haese J, Fangmann J, Farkas S, Grutzmann R, Glanemann M, Kalff JC, Mees ST, Mehrabi A, Michalski C, Pratschke J, Reissfelder C, Schmeding M, Schwarzbach M, Stavrou GA, Werner J, Klinger C, Buhr H, Bechstein WO, Schnitzbauer AA; DGAV StuDoQ-Registry. Textbook Outcome After Major Liver Resection for Primary and Secondary Liver Tumors at Specialized German Hepatobiliary Centers: Analysis of the StuDoQ Liver Registry. Ann Surg Oncol. 2025 Oct;32(10):7183-7194. doi: 10.1245/s10434-025-17866-w. Epub 2025 Aug 4.

    PubMed 40760319

Questions about this trial

What is this clinical trial studying?

An observational study of Liver Neoplasms and Hepatobiliary Diseases, run by Azienda USL Toscana Centro at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rosita De Vincenti, MD (+39 3204765618, rosita.devincenti@uslcentro.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative morbidity at 30 days (time frame: Within 30 days after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07556835, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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