Surgical Resection for Hepatocellular Carcinoma

Resectable Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06013657
• Other study ID #: DRCiptoMGH 19-11-1313
• Status: Completed
• Start date: December 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: August 2023
• Source: Dr Cipto Mangunkusumo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: June 1, 2022
• Est. primary completion date: March 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Resectable Hepatocellular Carcinoma

Intervention

Procedure:
• Liver Resection
Resection of a part of the liver afflicted by hepatocellular carcinoma

Locations

Country	Name	City	State
Indonesia	Dr. Cipto Mangunkusumo General Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Dr Cipto Mangunkusumo General Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality status of patients	Through study completion, an average of 3 years
Secondary	Age	Age in years	Within one week before surgery
Secondary	Sex	Male or Female	Within one week before surgery
Secondary	Etiology	Divided into hepatitis B, hepatitis C, and non-hepatitis in accordance with the laboratory results.	Within one month before surgery
Secondary	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
Secondary	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
Secondary	AFP Levels	Divided into <400 and >=400	Within one month before surgery
Secondary	Number of tumors	Divided into single and multiple tumors according to imaging findings	Within one month before surgery
Secondary	Largest diameter of tumor	Measured in cm according to imaging	Within one month before surgery
Secondary	Surgery method	Laparoscopy or open surgery	During surgery
Secondary	Segments resected	1-4 segments	During surgery
Secondary	Cirrhosis	Presence of cirrhosis in histopathological findings	Within one month after surgery
Secondary	Edmondson's grading	Histopathological grading divided into 1 to 4	Within one month after surgery
Secondary	Tumor differentiation	Histopathological grading divided well, moderate, moderate to poor, and poor	Within one month after surgery
Secondary	Length of stay	Measured in days from admission to discharge	An average of two weeks