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

NCT07556835 | Not Yet Recruiting

• 3 other identifiers: BILIVERBILIVER Protocol v1.030307_OSS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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. 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

Hepatobiliary Diseases; Cholangiocarcinoma; Liver Metastases From Colorectal Cancer; Liver Metastases; Biliary Tract Diseases; Benign Liver Disease; Liver Neoplasms; Hepatocellular Carcinoma; Gallbladder Carcinoma

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

Outcome Measures

Primary Outcomes (6)

• Postoperative morbidity at 30 days

  Postoperative complications classified according to the Clavien-Dindo classification

  Within 30 days after surgery

• Postoperative mortality at 30 days

  All-cause mortality after liver and/or biliary resection

  Within 30 days after surgery

• Postoperative morbidity at 90 days

  Postoperative complications classified according to the Clavien-Dindo classification

  Within 90 days after surgery

• Postoperative mortality at 90 days

  All-cause mortality after liver and/or biliary resection

  Within 90 days after surgery

• Overall survival (OS)

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

  Up to 5 years after surgery

• Disease-free survival (DFS)

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

  Up to 5 years after surgery

Secondary Outcomes (5)

• Severe postoperative complications

  Within 90 days after surgery

• Local and distant recurrence rate

  Up to 5 years after surgery

• Outcomes according to surgical approach

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

• Impact of preoperative risk factors

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

• Temporal trends and learning curve

  From January 1, 2015 through December 31, 2036

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda USL Toscana Centro: lead

Study Sites (1)

San Jacopo Hospital

Pistoia, Tuscany, 51100, Italy

Location

Related Publications (5)

• 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.

  PMID: 35946822 BACKGROUND

• 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.

  PMID: 35773091 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 40760319 BACKGROUND

MeSH Terms

Conditions

Liver Neoplasms; Digestive System Diseases; Cholangiocarcinoma; Carcinoma, Hepatocellular; Biliary Tract Diseases; Gallbladder Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Biliary Tract Neoplasms; Gallbladder Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rosita De Vincenti

  Azienda USL Toscana Centro

  PRINCIPAL INVESTIGATOR

• Massimo Fedi, MD

  Azienda USL Toscana Centro

  STUDY CHAIR

Central Study Contacts

Rosita De Vincenti, MD

CONTACT

+39 3204765618; rosita.devincenti@uslcentro.toscana.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General Surgeon

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 29, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): December 1, 2036
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)