Resectable Hepatocellular CarcinomaNCT06013657
Surgical Resection for Hepatocellular Carcinoma
An observational study of Resectable Hepatocellular Carcinoma, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Resectable Hepatocellular Carcinoma
- What is being tested?
- Liver Resection
- Type of treatment
- Surgery or procedure
- How many people
- 91 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2021to 1 Jun 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients undergoing liver resection in Cipto Mangunkusumo hospital due to a confirmed diagnosis of hepatocellular carcinoma from 2010 to 2021
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, 10440
About this study
Official title: 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.
Read the 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.
- Conditions
- Resectable Hepatocellular Carcinoma
- Being tested
- Liver Resection
- Keywords
- carcinoma,hepatocellular, liver neoplasms, hepatectomy, mortality, prognostic
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver ResectionProcedure or surgery
Also called Hepatectomy
Resection of a part of the liver afflicted by hepatocellular carcinoma
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Liver Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality status of patients
Measured: Through study completion, an average of 3 years
Secondary outcomes (14)
Age
Age in years
Measured: Within one week before surgery
Sex
Male or Female
Measured: Within one week before surgery
Etiology
Divided into hepatitis B, hepatitis C, and non-hepatitis in accordance with the laboratory results.
Measured: 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.
Measured: 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.
Measured: Within one month before surgery
AFP Levels
Divided into <400 and >=400
Measured: Within one month before surgery
Number of tumors
Divided into single and multiple tumors according to imaging findings
Measured: Within one month before surgery
Largest diameter of tumor
Measured in cm according to imaging
Measured: Within one month before surgery
Surgery method
Laparoscopy or open surgery
Measured: During surgery
Segments resected
1-4 segments
Measured: During surgery
Cirrhosis
Presence of cirrhosis in histopathological findings
Measured: Within one month after surgery
Edmondson's grading
Histopathological grading divided into 1 to 4
Measured: Within one month after surgery
Tumor differentiation
Histopathological grading divided well, moderate, moderate to poor, and poor
Measured: Within one month after surgery
Length of stay
Measured in days from admission to discharge
Measured: An average of two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start1 Dec 2021
- Primary completion25 Mar 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 91 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ridho Ardhi Syaiful, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013657
- Sponsor's protocol ID
- DRCiptoMGH 19-11-1313
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Raw data without the patients' identification in the form of an Excel sheet will be made available per private request via e-mail correspondence.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Resection for Hepatocellular Carcinoma: a Single-Center's One Decade of Experience
- ClinicalTrials.gov ID
- NCT06013657
- Acronym / sponsor ID
- DRCiptoMGH 19-11-1313
- Conditions
- Resectable Hepatocellular Carcinoma
- Keywords
- carcinoma,hepatocellular, liver neoplasms, hepatectomy, mortality, prognostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver resection | – | Procedure: Liver ResectionPatients undergoing liver resection due to hepatocellular carcinoma from 2010 to 2021 in RSCM, Jakarta, an academic tertiary-level national referral hospital in Indonesia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients undergoing liver resection in Cipto Mangunkusumo hospital due to a confirmed diagnosis of hepatocellular carcinoma from 2010 to 2021
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver ResectionAlso: HepatectomyResection of a part of the liver afflicted by hepatocellular carcinoma | Procedure or surgery | Liver resection |
Primary outcome
Mortality
Time frame: Through study completion, an average of 3 years
Mortality status of patients
14 secondary outcomes
Age
Time frame: Within one week before surgery
Sex
Time frame: Within one week before surgery
Etiology
Time frame: Within one month before surgery
Child-Pugh classification
Time frame: Within one month before surgery
BCLC Classification
Time frame: Within one month before surgery
AFP Levels
Time frame: Within one month before surgery
Number of tumors
Time frame: Within one month before surgery
Largest diameter of tumor
Time frame: Within one month before surgery
Surgery method
Time frame: During surgery
Segments resected
Time frame: During surgery
Cirrhosis
Time frame: Within one month after surgery
Edmondson's grading
Time frame: Within one month after surgery
Tumor differentiation
Time frame: Within one month after surgery
Length of stay
Time frame: An average of two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Individual participant dataSharing planned: Undecided. Raw data without the patients' identification in the form of an Excel sheet will be made available per private request via e-mail correspondence.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resectable Hepatocellular Carcinoma, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Through study completion, an average of 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.