Surgical Resection for Hepatocellular Carcinoma

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

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.

Study Overview

• Status: Completed
• Conditions: Resectable Hepatocellular Carcinoma
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10440
      • Dr. Cipto Mangunkusumo General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study used a total population sampling of all patients undergoing liver resection in Cipto Mangunkusumo hospital due to a confirmed diagnosis of hepatocellular carcinoma from 2010 to 2021. Patients undergoing liver resection in other hospitals were excluded, even though diagnosis or further care is done in RSCM. In addition, patients with other malignancies or undergoing other treatment methods were excluded.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality status of patients	Through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	Age in years	Within one week before surgery
Sex	Male or Female	Within one week before surgery
Etiology	Divided into hepatitis B, hepatitis C, and non-hepatitis in accordance with the laboratory results.	Within one month before surgery
Child-Pugh classification	Divided into Chilld-Pugh A,B, and C using clinical (presence of encephalopathy or ascites) and laboratory (prothrombin time, albumin, and bilirubin levels) data.	Within one month before surgery
BCLC Classification	Divided into Stages 0 and A to D using performance status, child-pugh classification, number and size (in cm) of the tumor.	Within one month before surgery
AFP Levels	Divided into <400 and >=400	Within one month before surgery
Number of tumors	Divided into single and multiple tumors according to imaging findings	Within one month before surgery
Largest diameter of tumor	Measured in cm according to imaging	Within one month before surgery
Surgery method	Laparoscopy or open surgery	During surgery
Segments resected	1-4 segments	During surgery
Cirrhosis	Presence of cirrhosis in histopathological findings	Within one month after surgery
Edmondson's grading	Histopathological grading divided into 1 to 4	Within one month after surgery
Tumor differentiation	Histopathological grading divided well, moderate, moderate to poor, and poor	Within one month after surgery
Length of stay	Measured in days from admission to discharge	An average of two weeks

Collaborators and Investigators

• Sponsor: Dr Cipto Mangunkusumo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): March 25, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: mortality; prognostic; liver neoplasms; hepatectomy; carcinoma,hepatocellular
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: DRCiptoMGH 19-11-1313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Raw data without the patients' identification in the form of an Excel sheet will be made available per private request via e-mail correspondence.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No