Hepatic MetastasesRELYNCT01073358
Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy
A study testing Routine hilar lymphadenectomy in people with Hepatic Metastases and Colorectal Cancer, run by Heidelberg University at 1 site in Germany.
Trial summary
It is uncertain, whether hilar lymphadenectomy should be performed routinely in patients undergoing resection of colorectal liver metastases. For this reason it is the aim of the present prospective randomized trial to evaluate, if routine lymphadenectomy reduces recurrent disease in patients undergoing resection of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Metastases, Colorectal Cancer
- What is being tested?
- Routine hilar lymphadenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteGermany
- Study dates
- 9 Mar 2010to Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for curative (R0) resection
- No evidence of extrahepatic disease
- No history of previous hepatic lymphadenectomy
- Age equal or greater than 18 years
- Written Informed consent
Who cannot join
- Expected lack of compliance
- Impaired mental state or language problems
- History of another primary cancer, except:
- Curatively treated in situ cervical cancer or curatively resected non-melanoma skin cancer
- Other primary solid tumour curatively treated with no known active disease present and no treatment administered for ≥ 5 years prior to randomisation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Gastrointestinal, Thoracic and Vascular Surgery
Dresden, 01307
About this study
Official title: Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy - A Randomized Controlled Trial
It is uncertain, whether hilar lymphadenectomy should be performed routinely in patients undergoing resection of colorectal liver metastases.
For this reason it is the aim of the present prospective randomized trial to evaluate, if routine lymphadenectomy reduces recurrent disease in patients undergoing resection of colorectal liver metastases.
Read the detailed description
Routine lymphadenectomy in patients undergoing hepatic resection for colorectal liver metastases may improve outcome of further patients due to the presence of micrometastases that have been shown to be of prognostic relevance. While previous studies highlight the clinical significance of perihepatic lymph node metastases, the outcome of patients with and without hilar lymphadenectomy has not yet been compared and thus no clear conclusion about the clinical value of routine hilar lymphadenectomy in CRC patients undergoing resection of liver metastases can be drawn from present data.
As disease recurrence occurs frequently and may affect up to 75 % of patients, further strategies are required to improve postoperative outcome. Routine hilar lymphadenectomy may offer an effective approach to remove residual disease and by this to reduce disease recurrence with little additional morbidity. For this reason it is the aim of the present prospective randomized trial to evaluate, if routine lymphadenectomy reduces recurrent disease in patients undergoing resection of colorectal liver metastases.
- Conditions
- Hepatic Metastases, Colorectal Cancer
- Being tested
- Routine hilar lymphadenectomy
- Keywords
- resectable hepatic metastases of colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine hilar lymphadenectomyProcedure or surgery
Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases
| Study group | Role | What they receive |
|---|---|---|
| Group A: No routine hilar lymphadenectomy | No intervention | Resection of colorectal liver metastases without routine hilar lymphadenectomy |
| Group B: Routine hilar lymphadenectomy | Experimental | Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases. Receives: Procedure: Routine hilar lymphadenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of disease recurrence
Measured: 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study start9 Mar 2010
- Primary completionJul 2019 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic MetastasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuh Rahbari, University Hospital Carl Gustav Carus
- Investigators
- Jürgen Weitz, MD, MSc, Principal investigator, Department of Gastrointestinal, Thoracic and Vascular Surgery Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073358
- Sponsor's protocol ID
- NNR-5
- Acronym
- RELY
- Status last verified
- Oct 2017
- First submitted
- 22 Feb 2010
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resection of Colorectal Liver Metastases With or Without Routine Hilar Lymphadenectomy - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01073358
- Acronym / sponsor ID
- RELY / NNR-5
- Conditions
- Hepatic Metastases, Colorectal Cancer
- Keywords
- resectable hepatic metastases of colorectal cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- 9 Mar 2010 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Feb 2010 (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.
It is uncertain, whether hilar lymphadenectomy should be performed routinely in patients undergoing resection of colorectal liver metastases.
For this reason it is the aim of the present prospective randomized trial to evaluate, if routine lymphadenectomy reduces recurrent disease in patients undergoing resection of colorectal liver metastases.
Detailed description
Routine lymphadenectomy in patients undergoing hepatic resection for colorectal liver metastases may improve outcome of further patients due to the presence of micrometastases that have been shown to be of prognostic relevance. While previous studies highlight the clinical significance of perihepatic lymph node metastases, the outcome of patients with and without hilar lymphadenectomy has not yet been compared and thus no clear conclusion about the clinical value of routine hilar lymphadenectomy in CRC patients undergoing resection of liver metastases can be drawn from present data.
As disease recurrence occurs frequently and may affect up to 75 % of patients, further strategies are required to improve postoperative outcome. Routine hilar lymphadenectomy may offer an effective approach to remove residual disease and by this to reduce disease recurrence with little additional morbidity. For this reason it is the aim of the present prospective randomized trial to evaluate, if routine lymphadenectomy reduces recurrent disease in patients undergoing resection of colorectal liver metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: No routine hilar lymphadenectomy | No intervention | –Resection of colorectal liver metastases without routine hilar lymphadenectomy |
| Group B: Routine hilar lymphadenectomy | Experimental | Procedure: Routine hilar lymphadenectomyHilar lymphadenectomy is performed before actual resection of the colorectal liver metastases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled for curative (R0) resection
- No evidence of extrahepatic disease
- No history of previous hepatic lymphadenectomy
- Age equal or greater than 18 years
- Written Informed consent
Key exclusion criteria (5 listed)
- Expected lack of compliance
- Impaired mental state or language problems
- History of another primary cancer, except:
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 |
|---|---|---|
| Routine hilar lymphadenectomyHilar lymphadenectomy is performed before actual resection of the colorectal liver metastases | Procedure or surgery | Group B: Routine hilar lymphadenectomy |
Primary outcome
rate of disease recurrence
Time frame: 2 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
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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.
Jürgen Weitz, MD, MSc principal investigator
Department of Gastrointestinal, Thoracic and Vascular Surgery Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine hilar lymphadenectomy in people with Hepatic Metastases and Colorectal Cancer, run by Heidelberg University at 1 site in Germany.
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 5 inclusion and 5 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 27 Oct 2017. 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 Germany. 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?
rate of disease recurrence (time frame: 2 years after surgery). 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 27 Oct 2017.