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临床试验/NCT06013657
NCT06013657已完成不适用

Surgical Resection for Hepatocellular Carcinoma: a Single-Center's One Decade of Experience

Dr Cipto Mangunkusumo General Hospital1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
91
试验地点
1
主要终点
Mortality

研究概览

简要总结

Hepatocellular carcinoma is a type of liver cancer and is one of the leading causes of global cancer death. Surgical resection of the afflicted areas of the liver is one of the treatment methods for this condition. In this retrospective research, the investigators explore the outcomes of liver resection for hepatocellular carcinoma patients undergoing liver resection from 2010 to 2021 in Cipto Mangunkusumo General Hospital, Jakarta. The main outcome is mortality and the secondary outcomes are factors predicting mortality after resection.

详细描述

Study design This is a retrospective cohort study.

Treatment of Hepatocellular Carcinoma Patients in RSCM HCC patients are managed by a multidisciplinary team (MDT) consisting of hepatologists, radiologists, pathologists, radiation oncologists, surgeons, and other specialists related to the patient's condition. Confirmed HCC patients are discussed in a weekly MDT team meeting. The meeting assigned patients to treatment options according to the Barcelona Clinic Liver Center (BCLC) staging system, patient preference, and other clinical considerations. Resection is considered for patients at very early (BCLC 0) or early (BCLC A) HCC stages. This includes CP class A patients with a single tumor or less than three small (<3 cm) tumors. Patients assigned to surgical resection underwent either laparoscopic or open surgery. One to four segments of the liver were removed. Tissue samples were taken for further pathologic examination.

Ethical Clearance The ethics committee of The Faculty of Medicine, University of Indonesia, approved this study by giving an ethical clearance with protocol number 19-11-1313. Informed consent was taken from all patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergoing liver resection in Cipto Mangunkusumo hospital due to a confirmed diagnosis of hepatocellular carcinoma from 2010 to 2021

排除标准

  • Patients undergoing liver resection in other hospitals were excluded, even though diagnosis or further care is done in Cipto Mangunkusumo hospital
  • Patients with other malignancies
  • Patients undergoing other treatment methods for hepatocellular carcinoma.

结局指标

主要结局

Mortality

时间窗: Through study completion, an average of 3 years

Mortality status of patients

次要结局

  • Child-Pugh classification(Within one month before surgery)
  • Largest diameter of tumor(Within one month before surgery)
  • Segments resected(During surgery)
  • Age(Within one week before surgery)
  • Sex(Within one week before surgery)
  • Etiology(Within one month before surgery)
  • BCLC Classification(Within one month before surgery)
  • AFP Levels(Within one month before surgery)
  • Number of tumors(Within one month before surgery)
  • Cirrhosis(Within one month after surgery)
  • Surgery method(During surgery)
  • Edmondson's grading(Within one month after surgery)
  • Tumor differentiation(Within one month after surgery)
  • Length of stay(An average of two weeks)

研究者

发起方
Dr Cipto Mangunkusumo General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ridho Ardhi Syaiful

Principal investigator

Dr Cipto Mangunkusumo General Hospital

研究点 (1)

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