Clinical trial · Observational
Outcomes After Liver and Biliary Resection at a High-Volume Center
Ambispective Cohort Study of Clinical and Oncologic Outcomes in Patients Undergoing Liver and Biliary Resection at San Jacopo Hospital, Pistoia
NCT07556835CI-TRIAL-00109707BILIVERnot yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Benign Liver Disease | — | UNRESOLVED | — |
| Biliary Tract Diseases | — | UNRESOLVED | — |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Gallbladder Carcinoma | Gallbladder Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Hepatobiliary Diseases | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Metastases | — | UNRESOLVED | — |
| Liver Metastases From Colorectal Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (6)
- measure
- Postoperative morbidity at 30 days
- timeFrame
- Within 30 days after surgery
- description
- Postoperative complications classified according to the Clavien-Dindo classification
- measure
- Postoperative mortality at 30 days
- timeFrame
- Within 30 days after surgery
- description
- All-cause mortality after liver and/or biliary resection
- measure
- Postoperative morbidity at 90 days
- timeFrame
- Within 90 days after surgery
- description
- Postoperative complications classified according to the Clavien-Dindo classification
- measure
- Postoperative mortality at 90 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDGorgec 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. PMID 35946822
- BACKGROUNDde 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. PMID 35773091
- BACKGROUNDNicolazzi 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
- BACKGROUNDAlaimo 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
- BACKGROUNDHeil 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.