Clinical trial NCT06013657: Surgical Resection for Hepatocellular Carcinoma
Official title: Surgical Resection for Hepatocellular Carcinoma: a Single-Center's One Decade of Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resectable Hepatocellular Carcinoma
Keywords: carcinoma,hepatocellular
liver neoplasms
hepatectomy
mortality
prognostic
Lead sponsor: Dr Cipto Mangunkusumo General Hospital
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 91
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: Through study completion, an average of 3 years
Secondary outcomes:
measure: Age
timeFrame: Within one week before surgery
measure: Sex
timeFrame: Within one week before surgery
measure: Etiology
timeFrame: Within one month before surgery
measure: Child-Pugh classification
timeFrame: Within one month before surgery
measure: BCLC Classification
timeFrame: Within one month before surgery
measure: AFP Levels
timeFrame: Within one month before surgery
measure: Number of tumors
timeFrame: Within one month before surgery
measure: Largest diameter of tumor
timeFrame: Within one month before surgery
measure: Surgery method
timeFrame: During surgery
measure: Segments resected
timeFrame: During surgery
measure: Cirrhosis
timeFrame: Within one month after surgery
measure: Edmondson's grading
timeFrame: Within one month after surgery
measure: Tumor differentiation
timeFrame: Within one month after surgery
measure: Length of stay
timeFrame: An average of two weeks
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Dr. Cipto Mangunkusumo General Hospital
state: DKI Jakarta
Study officials:
References: