Colorectal Cancer With Liver MetastasisLNNCT01565811
Prospective Phase II Trial on Prophylactic Perihepatic Lymphadenectomy in Patients With Colorectal Cancer With Liver Metastasis
An observational study of Colorectal Cancer With Liver Metastasis, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
Objective: To evaluate the role of regional lymphadenectomy in patients with colorectal cancer liver metastasis. Background: Lymph node status is 1 of the most important prognostic factors in oncologic surgery; however, the role of lymph node dissection remains unclear for colorectal cancer liver metastasis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer With Liver Metastasis
- What is being tested?
- perihepatic lymphadenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Dec 2013
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Biopsy confirmed colorectal cancer with liver metastasis
Who may be able to join
- first hepatectomy;
- age <75 years;
- absence of severe cardiovascular,pulmonary, or other associated diseases;
- absence of other malignant disease;
- absence of distant metastases secondary to colorectal cancer other than liver metastases (except a solitary peritoneal tumor that could be completely resected during hepatectomy); and
- complete resection of liver metastases confirmed during surgery.
Who cannot join
- HNPCC
- FAP
- patient who refuses perihepatic lymphadnectomy
- medical condition in which surgery cannot be tolerated
Trial locations and contacts
1 site in 1 country.
About this study
Objective: To evaluate the role of regional lymphadenectomy in patients with colorectal cancer liver metastasis. Background: Lymph node status is 1 of the most important prognostic factors in oncologic surgery; however, the role of lymph node dissection remains unclear for colorectal cancer liver metastasis.
Read the detailed description
Lymph node status is a definite prognostic factor in oncologic surgery and significantly affects long-term survival, as reported by the tumor staging system of the International Union Against Cancer (IUCC), which is the most widespread classification of malignant tumors worldwide. Regional lymphadenectomy is already the standard procedure that completes hepatic resection in the case of carcinoma arising from the extrahepatic bile duct. However, the indication, extent, and role of lymph node excision are still a matter of discussion, and no clear guidelines exist in patients with colorectal cancer liver metastasis.
- Conditions
- Colorectal Cancer With Liver Metastasis
- Being tested
- perihepatic lymphadenectomy
- Keywords
- colon neoplasm, rectal neoplasm, liver metastasis
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perihepatic lymphadenectomyProcedure or surgery
Hepatic pedicle lymph node dissection according to the protocol of the prospective multicentric study.Namely the six main groups of lymph nodes removed (HA,hepatic artery; CA, celiac axis; BD, common bile duct).
| Study group | Role | What they receive |
|---|---|---|
| Hepatic pedicle lymph node Involvement | Intervention Type: perihepatic lymphadenectomy(surgical procedure) Receives: Procedure: perihepatic lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
complication rate
Measured: within 3months
Secondary outcomes (1)
To evaluate prognostic significance of perihepatic LN involvement with overall survival and disease free survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startAug 2010
- Primary completionMar 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer With Liver MetastasisStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won-Suk Lee, Gachon University Gil Medical Center
- Investigators
- Won-Suk Lee, MD, Principal investigator, Gil Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565811
- Sponsor's protocol ID
- girba2291
- Acronym
- LN
- Status last verified
- Aug 2015
- First submitted
- 27 Mar 2012
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase II Trial on Prophylactic Perihepatic Lymphadenectomy in Patients With Colorectal Cancer With Liver Metastasis
- ClinicalTrials.gov ID
- NCT01565811
- Acronym / sponsor ID
- LN / girba2291
- Conditions
- Colorectal Cancer With Liver Metastasis
- Keywords
- colon neoplasm, rectal neoplasm, liver metastasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Mar 2012 (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.
Objective: To evaluate the role of regional lymphadenectomy in patients with colorectal cancer liver metastasis. Background: Lymph node status is 1 of the most important prognostic factors in oncologic surgery; however, the role of lymph node dissection remains unclear for colorectal cancer liver metastasis.
Detailed description
Lymph node status is a definite prognostic factor in oncologic surgery and significantly affects long-term survival, as reported by the tumor staging system of the International Union Against Cancer (IUCC), which is the most widespread classification of malignant tumors worldwide. Regional lymphadenectomy is already the standard procedure that completes hepatic resection in the case of carcinoma arising from the extrahepatic bile duct. However, the indication, extent, and role of lymph node excision are still a matter of discussion, and no clear guidelines exist in patients with colorectal cancer liver metastasis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatic pedicle lymph node Involvement | – | Procedure: perihepatic lymphadenectomyIntervention Type: perihepatic lymphadenectomy(surgical procedure) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Biopsy confirmed colorectal cancer with liver metastasis
Key inclusion criteria (6 listed)
- first hepatectomy;
- age <75 years;
- absence of severe cardiovascular,pulmonary, or other associated diseases;
- absence of other malignant disease;
- absence of distant metastases secondary to colorectal cancer other than liver metastases (except a solitary peritoneal tumor that could be completely resected during hepatectomy); and
Key exclusion criteria (4 listed)
- HNPCC
- FAP
- patient who refuses perihepatic lymphadnectomy
- medical condition in which surgery cannot be tolerated
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 |
|---|---|---|
| perihepatic lymphadenectomyHepatic pedicle lymph node dissection according to the protocol of the prospective multicentric study.Namely the six main groups of lymph nodes removed (HA,hepatic artery; CA, celiac axis; BD, common bile duct). | Procedure or surgery | Hepatic pedicle lymph node Involvement |
Primary outcome
complication rate
Time frame: within 3months
1 secondary outcome
To evaluate prognostic significance of perihepatic LN involvement with overall survival and disease free survival
Time frame: 3 years
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 1 Sep 2015.
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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.
Won-Suk Lee, MD principal investigator
Gil Hospital
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 Colorectal Cancer With Liver Metastasis, run by Gachon University Gil Medical Center 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 6 inclusion and 4 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 1 Sep 2015. 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?
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?
complication rate (time frame: within 3months). 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 1 Sep 2015.