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

Официальное название

Ambispective Cohort Study of Clinical and Oncologic Outcomes in Patients Undergoing Liver and Biliary Resection at San Jacopo Hospital, Pistoia

Обзор

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

Подробное описание

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.

Первичные конечные точки

• Postoperative morbidity at 30 days [Срок оценки: Within 30 days after surgery]
• Postoperative mortality at 30 days [Срок оценки: Within 30 days after surgery]
• Postoperative morbidity at 90 days [Срок оценки: Within 90 days after surgery]
• Postoperative mortality at 90 days [Срок оценки: Within 90 days after surgery]
• Overall survival (OS) [Срок оценки: Up to 5 years after surgery]
• Disease-free survival (DFS) [Срок оценки: Up to 5 years after surgery]

Вторичные конечные точки (5)

• Severe postoperative complications [Срок оценки: Within 90 days after surgery]
• Local and distant recurrence rate [Срок оценки: Up to 5 years after surgery]
• Outcomes according to surgical approach [Срок оценки: Within 90 days after surgery and up to 5 years after surgery]
• Impact of preoperative risk factors [Срок оценки: Within 90 days after surgery and up to 5 years after surgery]
• Temporal trends and learning curve [Срок оценки: From January 1, 2015 through December 31, 2036]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Италия · 1 центр

• San Jacopo Hospital — Pistoia

Публикации

• 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

Идентификаторы

NCT: NCT07556835 · BILIVER · BILIVER Protocol v1.0 · 30307_OSS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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