Hepatocellular CarcinomaNCT02031952
Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma
A study testing hepatectomy combined with lymphadenectomy and hepatectomy alone in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial summary
The preventive lymphadenectomy is not performed routinely for hepatocellular carcinoma (HCC) patients in clinical practice. While many patients suffered the recurrence without the evidence of portal or hepatic vascular invasion or multiple loci, it lead to reconsider the value of preventive resection of regional lymph… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- hepatectomy combined with lymphadenectomy and hepatectomy alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteChina
- Study dates
- Dec 2005to Jun 2013
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 to 65 years;
- Eastern Cooperative Oncology Group (ECOG) Performance Status is grade 0 or 1;
- good liver function with Pugh-Child Class A or B;
- indocyanine green retention at 15 minutes (ICG-R15) <15%;
- without severe cirrhosis;
- the diameter of tumor is equal to or more than 3 cm;
- the liver resection could be assessed R0 (the define of R0 resection will be explained in the section of Surgical procedures);
- absence of extrahepatic metastasis.
Who cannot join
- the diameter of tumor is less than 3 cm;
- palliative resection of tumor;
- with the history of hepatic encephalopathy, ascites, and variceal bleeding;
- with severe hepatic cirrhosis;
- tumor rupture;
- with the history of upper abdominal surgery, it is tough to remove the regional lymph nodes; or it is unable to be resected when multiple lymph nodes mixed and fixed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma ----A Prospective Randomized Controlled Clinical Trail
The preventive lymphadenectomy is not performed routinely for hepatocellular carcinoma (HCC) patients in clinical practice. While many patients suffered the recurrence without the evidence of portal or hepatic vascular invasion or multiple loci, it lead to reconsider the value of preventive resection of regional lymph node for those patients. Recently, more and more studies had found the incidence of lymph node metastasis was higher in autopsy specimen than those in operable patients.
This project is a prospective randomized controlled trial, planning to compare hepatectomy with hepatectomy combined lymphadenectomy regarding of the safety and efficacy in HCC patients, to reach a further understanding of the role of lymphadenectomy.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- hepatectomy combined with lymphadenectomy, hepatectomy alone
- Keywords
- hepatocellular carcinoma, hepatectomy, lymphadenectomy, complication, prognosis
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatectomy combined with lymphadenectomyProcedure or surgery
hepatectomy aloneProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| hepatectomy combined lymphadenectomy | Experimental | hepatectomy combined lymphadenectomy Receives: Procedure: hepatectomy combined with lymphadenectomy |
| hepatectomy | Active comparator | hepatectomy alone Receives: Procedure: hepatectomy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
The recurrence-free survival time was defined as the time from the date of resection or ablation to the time of recurrence, metastasis or last follow-up.
Measured: 5 year
Secondary outcomes (1)
Post-operation complication
Measured: 90-d after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startDec 2005
- Primary completionDec 2010
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunfei Yuan, Sun Yat-sen University
- Investigators
- Yunfei Yuan, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031952
- Sponsor's protocol ID
- Rvrl2005
- Status last verified
- Jan 2014
- First submitted
- 4 Jan 2014
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatectomy Versus Hepatectomy With Lymphadenectomy in Hepatocellular Carcinoma ----A Prospective Randomized Controlled Clinical Trail
- ClinicalTrials.gov ID
- NCT02031952
- Acronym / sponsor ID
- Rvrl2005
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, hepatectomy, lymphadenectomy, complication, prognosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Jan 2014 (estimated)
- 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.
The preventive lymphadenectomy is not performed routinely for hepatocellular carcinoma (HCC) patients in clinical practice. While many patients suffered the recurrence without the evidence of portal or hepatic vascular invasion or multiple loci, it lead to reconsider the value of preventive resection of regional lymph node for those patients. Recently, more and more studies had found the incidence of lymph node metastasis was higher in autopsy specimen than those in operable patients.
This project is a prospective randomized controlled trial, planning to compare hepatectomy with hepatectomy combined lymphadenectomy regarding of the safety and efficacy in HCC patients, to reach a further understanding of the role of lymphadenectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hepatectomy combined lymphadenectomy | Experimental | Procedure: hepatectomy combined with lymphadenectomyhepatectomy combined lymphadenectomy |
| hepatectomy | Active comparator | Procedure: hepatectomy alonehepatectomy alone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age 18 to 65 years;
- Eastern Cooperative Oncology Group (ECOG) Performance Status is grade 0 or 1;
- good liver function with Pugh-Child Class A or B;
- indocyanine green retention at 15 minutes (ICG-R15) <15%;
- without severe cirrhosis;
Key exclusion criteria (6 listed)
- the diameter of tumor is less than 3 cm;
- palliative resection of tumor;
- with the history of hepatic encephalopathy, ascites, and variceal bleeding;
- with severe hepatic cirrhosis;
- tumor rupture;
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 |
|---|---|---|
| hepatectomy combined with lymphadenectomy | Procedure or surgery | hepatectomy combined lymphadenectomy |
| hepatectomy alone | Procedure or surgery | hepatectomy |
Primary outcome
Recurrence-free survival
Time frame: 5 year
The recurrence-free survival time was defined as the time from the date of resection or ablation to the time of recurrence, metastasis or last follow-up.
1 secondary outcome
Post-operation complication
Time frame: 90-d after surgery
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 9 Jan 2014.
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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.
Yunfei Yuan, MD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hepatectomy combined with lymphadenectomy and hepatectomy alone in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.
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 8 inclusion and 6 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 9 Jan 2014. 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 China. 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?
Recurrence-free survival (time frame: 5 year). 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 9 Jan 2014.