Surgical Resection for Hepatocellular Carcinoma

Sponsor

Dr Cipto Mangunkusumo General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06013657

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

15.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Resectable Hepatocellular Carcinoma	Procedure: Liver Resection

Detailed Description

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

91 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Dec 1, 2021

Actual Primary Completion Date :

Mar 25, 2022

Actual Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Liver resection Patients undergoing liver resection due to hepatocellular carcinoma from 2010 to 2021 in RSCM, Jakarta, an academic tertiary-level national referral hospital in Indonesia.	Procedure: Liver Resection Resection of a part of the liver afflicted by hepatocellular carcinoma Other Names: Hepatectomy

Arm

Intervention/Treatment

Liver resection

Patients undergoing liver resection due to hepatocellular carcinoma from 2010 to 2021 in RSCM, Jakarta, an academic tertiary-level national referral hospital in Indonesia.

Procedure: Liver Resection

Resection of a part of the liver afflicted by hepatocellular carcinoma

Other Names:

Hepatectomy

Outcome Measures

Primary Outcome Measures

Mortality [Through study completion, an average of 3 years]
Mortality status of patients

Secondary Outcome Measures

Age [Within one week before surgery]
Age in years
Sex [Within one week before surgery]
Male or Female
Etiology [Within one month before surgery]
Divided into hepatitis B, hepatitis C, and non-hepatitis in accordance with the laboratory results.
Child-Pugh classification [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.
BCLC Classification [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.
AFP Levels [Within one month before surgery]
Divided into <400 and >=400
Number of tumors [Within one month before surgery]
Divided into single and multiple tumors according to imaging findings
Largest diameter of tumor [Within one month before surgery]
Measured in cm according to imaging
Surgery method [During surgery]
Laparoscopy or open surgery
Segments resected [During surgery]
1-4 segments
Cirrhosis [Within one month after surgery]
Presence of cirrhosis in histopathological findings
Edmondson's grading [Within one month after surgery]
Histopathological grading divided into 1 to 4
Tumor differentiation [Within one month after surgery]
Histopathological grading divided well, moderate, moderate to poor, and poor
Length of stay [An average of two weeks]
Measured in days from admission to discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.