Ambispective Cohort Study of Clinical and Oncologic Outcomes in Patients Undergoing Liver and Biliary Resection at San Jacopo Hospital, Pistoia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Postoperative morbidity at 30 days
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Postoperative morbidity at 30 days
时间窗: Within 30 days after surgery
Postoperative complications classified according to the Clavien-Dindo classification
Postoperative mortality at 30 days
时间窗: Within 30 days after surgery
All-cause mortality after liver and/or biliary resection
Postoperative morbidity at 90 days
时间窗: Within 90 days after surgery
Postoperative complications classified according to the Clavien-Dindo classification
Postoperative mortality at 90 days
时间窗: Within 90 days after surgery
All-cause mortality after liver and/or biliary resection
Overall survival (OS)
时间窗: Up to 5 years after surgery
Time from surgery to death from any cause in patients with malignant disease
Disease-free survival (DFS)
时间窗: Up to 5 years after surgery
Time from surgery to disease recurrence or death in patients with malignant disease
次要结局
- 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)
研究者
Rosita De Vincenti
General Surgeon
Azienda USL Toscana Centro