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NCT Number: NCT06013657

Surgical Resection for Hepatocellular Carcinoma

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.

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Key information

Conditions

Resectable Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10440, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

liver resection

Procedure

Resection of a part of the liver afflicted by hepatocellular carcinoma

Other names: Hepatectomy

Primary outcomes

  1. Mortality

    Time frame: Through study completion, an average of 3 years

    Mortality status of patients

Secondary outcomes

  1. Age

    Time frame: Within one week before surgery

    Age in years

  2. Sex

    Time frame: Within one week before surgery

    Male or Female

  3. Etiology

    Time frame: Within one month before surgery

    Divided into hepatitis B, hepatitis C, and non-hepatitis in accordance with the laboratory results.

  4. Child-Pugh classification

    Time frame: Within one month before surgery

    Divided into Chilld-Pugh A,B, and C using clinical (presence of encephalopathy or ascites) and laboratory (prothrombin time, albumin, and bilirubin levels) data.

  5. BCLC Classification

    Time frame: Within one month before surgery

    Divided into Stages 0 and A to D using performance status, child-pugh classification, number and size (in cm) of the tumor.

  6. AFP Levels

    Time frame: Within one month before surgery

    Divided into <400 and >=400

  7. Number of tumors

    Time frame: Within one month before surgery

    Divided into single and multiple tumors according to imaging findings

  8. Largest diameter of tumor

    Time frame: Within one month before surgery

    Measured in cm according to imaging

  9. Surgery method

    Time frame: During surgery

    Laparoscopy or open surgery

  10. Segments resected

    Time frame: During surgery

    1-4 segments

  11. Cirrhosis

    Time frame: Within one month after surgery

    Presence of cirrhosis in histopathological findings

  12. Edmondson's grading

    Time frame: Within one month after surgery

    Histopathological grading divided into 1 to 4

  13. Tumor differentiation

    Time frame: Within one month after surgery

    Histopathological grading divided well, moderate, moderate to poor, and poor

  14. Length of stay

    Time frame: An average of two weeks

    Measured in days from admission to discharge

Sponsors and collaborators

Lead sponsor

Dr Cipto Mangunkusumo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2023
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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