Outcomes After Liver and Biliary Resection at a High-Volume Center
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Liver Neoplasms, Hepatobiliary Diseases, Cholangiocarcinoma, Hepatocellular Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ambispective Cohort Study of Clinical and Oncologic Outcomes in Patients Undergoing Liver and Biliary Resection at San Jacopo Hospital, Pistoia
Overview
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
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.
Primary outcome measures
- Postoperative morbidity at 30 days [Time frame: Within 30 days after surgery]
- Postoperative mortality at 30 days [Time frame: Within 30 days after surgery]
- Postoperative morbidity at 90 days [Time frame: Within 90 days after surgery]
- Postoperative mortality at 90 days [Time frame: Within 90 days after surgery]
- Overall survival (OS) [Time frame: Up to 5 years after surgery]
- Disease-free survival (DFS) [Time frame: Up to 5 years after surgery]
Secondary outcome measures (5)
- Severe postoperative complications [Time frame: Within 90 days after surgery]
- Local and distant recurrence rate [Time frame: 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]
- Impact of preoperative risk factors [Time frame: 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- San Jacopo Hospital — Pistoia
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 PMID 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 PMID 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. PMID 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. PMID 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 PMID 40760319
Identifiers
NCT: NCT07556835 · BILIVER · BILIVER Protocol v1.0 · 30307_OSS