Hepatocellular CarcinomaHCCNCT00606385
Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for HCC
A study testing Liver resection in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Short-term outcomes of laparoscopic liver resection is better than those of open liver resection Laparoscopic liver resection is better than open resection in immunological aspects Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Liver resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2007to Jun 2017
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiologically diagnosed hepatocellular carcinoma
- Child classification A or B
- Aged 20 to 80
- Informed consent taken
Who cannot join
- Child classification C
- Extrahepatic metastasis
- Tumor located in central area or adjacent to middle hepatic vein
- Recurred hepatocellular carcinoma
- Critically ill patient
- Patient with psychiatric disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for Patients With Hepatocellular Carcinoma
Short-term outcomes of laparoscopic liver resection is better than those of open liver resection
Laparoscopic liver resection is better than open resection in immunological aspects
Read the detailed description
Advantages and disadvantages of the laparoscopic compared with the open approach for liver resections
- Advantages 1) Less postoperative ascites production 2) Reduced postoperative pain 3) Feasible in selected cirrhotics who have contraindications to open surgery 4) Less intra-abdominal adhesions (easier salvage transplantation) 5) Shorter recovery time 6) Shorter length of stay 7) Reduced financial cost
- Disadvantages 1) No manual palpation or exploration of the liver parenchyma possible (with the pure laparoscopic approach) 2) High demand in surgical skill (especially major resections)
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Liver resection
- Keywords
- Recurrence, Survival, Immunology, Laparoscopy
- Medical subject headings
- Carcinoma, Hepatocellular, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver resectionProcedure or surgery
Laparoscopic or Open hepatectomy
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic liver resection | Experimental | Patients who underwent laparoscopic liver resection for HCC Receives: Procedure: Liver resection |
| open liver resection | Active comparator | Patients who underwent open liver resection for HCC Receives: Procedure: Liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Measured: 2 years after operation
Secondary outcomes (1)
Survival
Measured: 2 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho-Seong Han, Seoul National University Hospital
- Investigators
- Ho-Seong Han, MD, PhD, Study chair, Department of Surgery, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606385
- Sponsor's protocol ID
- SNUBH-GS-HBP1
- Other IDs
- SNUBH-GS-HBP1
- Acronym
- HCC
- Status last verified
- Oct 2016
- First submitted
- 21 Jan 2008
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Yoon YS, Han HS, Choi YS, Jang JY, Suh KS, Kim SW, Lee KU, Park YH. Total laparoscopic right posterior sectionectomy for hepatocellular carcinoma. J Laparoendosc Adv Surg Tech A. 2006 Jun;16(3):274-7. doi: 10.1089/lap.2006.16.274.
PubMed 16796440Min SK, Han HS, Kim SW, Park YH, Lee HO, Lee JH. Initial experiences with laparoscopy-assisted and total laparoscopy for anatomical liver resection: a preliminary study. J Korean Med Sci. 2006 Feb;21(1):69-74. doi: 10.3346/jkms.2006.21.1.69.
PubMed 16479068Yoon YS, Han HS, Choi YS, Lee SI, Jang JY, Suh KS, Kim SW, Lee KU, Park YH. Total laparoscopic left lateral sectionectomy performed in a child with benign liver mass. J Pediatr Surg. 2006 Jan;41(1):e25-8. doi: 10.1016/j.jpedsurg.2005.10.068.
PubMed 16410084
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial of Laparoscopic Versus Open Liver Resection for Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT00606385
- Acronym / sponsor ID
- HCC / SNUBH-GS-HBP1
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Recurrence, Survival, Immunology, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 4 Feb 2008 (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.
Short-term outcomes of laparoscopic liver resection is better than those of open liver resection
Laparoscopic liver resection is better than open resection in immunological aspects
Detailed description
Advantages and disadvantages of the laparoscopic compared with the open approach for liver resections
- Advantages 1) Less postoperative ascites production 2) Reduced postoperative pain 3) Feasible in selected cirrhotics who have contraindications to open surgery 4) Less intra-abdominal adhesions (easier salvage transplantation) 5) Shorter recovery time 6) Shorter length of stay 7) Reduced financial cost
- Disadvantages 1) No manual palpation or exploration of the liver parenchyma possible (with the pure laparoscopic approach) 2) High demand in surgical skill (especially major resections)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic liver resection | Experimental | Procedure: Liver resectionPatients who underwent laparoscopic liver resection for HCC |
| open liver resection | Active comparator | Procedure: Liver resectionPatients who underwent open liver resection for HCC |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Radiologically diagnosed hepatocellular carcinoma
- Child classification A or B
- Aged 20 to 80
- Informed consent taken
Key exclusion criteria (6 listed)
- Child classification C
- Extrahepatic metastasis
- Tumor located in central area or adjacent to middle hepatic vein
- Recurred hepatocellular carcinoma
- Critically ill patient
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 resectionLaparoscopic or Open hepatectomy | Procedure or surgery | laparoscopic liver resection, open liver resection |
Primary outcome
Recurrence rate
Time frame: 2 years after operation
1 secondary outcome
Survival
Time frame: 2 years after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Background: PubMed 16796440Yoon YS, Han HS, Choi YS, Jang JY, Suh KS, Kim SW, Lee KU, Park YH. Total laparoscopic right posterior sectionectomy for hepatocellular carcinoma. J Laparoendosc Adv Surg Tech A. 2006 Jun;16(3):274-7. doi: 10.1089/lap.2006.16.274.
- Background: PubMed 16479068Min SK, Han HS, Kim SW, Park YH, Lee HO, Lee JH. Initial experiences with laparoscopy-assisted and total laparoscopy for anatomical liver resection: a preliminary study. J Korean Med Sci. 2006 Feb;21(1):69-74. doi: 10.3346/jkms.2006.21.1.69.
- Background: PubMed 16410084Yoon YS, Han HS, Choi YS, Lee SI, Jang JY, Suh KS, Kim SW, Lee KU, Park YH. Total laparoscopic left lateral sectionectomy performed in a child with benign liver mass. J Pediatr Surg. 2006 Jan;41(1):e25-8. doi: 10.1016/j.jpedsurg.2005.10.068.
- Individual participant dataSharing planned: No
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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.
Ho-Seong Han, MD, PhD study chair
Department of Surgery, Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver resection in people with Hepatocellular Carcinoma, run by Seoul National University Hospital at 1 site in South Korea.
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 4 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: status not confirmed, as of the sponsor's last update on 28 Oct 2016. 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 South Korea. 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?
Results are not available in the source record.
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 rate (time frame: 2 years after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00606385, which also lists 3 linked publications.
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 Oct 2016.