Lymph Node MetastasesNCT03314961
Lymph Node Metastases and Arterial Ligation in Rectal Cancer Surgery
An observational study of Lymph Node Metastases, run by Region Västmanland.
Trial summary
Lymph node status is of major prognostic importance in non-metastatic rectal cancer. For oncological reasons, central arterial ligation of the inferior mesenteric artery (IMA) is suggested. However, there is no conclusive evidence presented for this procedure. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lymph Node Metastases
- How many people
- 151 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2016
- 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: All patients that were diagnosed with rectal cancer 2012-2016 in Västmanlands county.
Who may be able to join
- All patients that were curatively operated for rectal cancer in Västmanlands county 2012-2016.
Who cannot join
- Patients that were not operated or had another type of cancer.
About this study
Official title: Localisation of Mesenteric Lymph Node Metastases and Role of Level of Arterial Ligation in Rectal Cancer Surgery
Lymph node status is of major prognostic importance in non-metastatic rectal cancer. For oncological reasons, central arterial ligation of the inferior mesenteric artery (IMA) is suggested. However, there is no conclusive evidence presented for this procedure.
This study aimed at investigating the localisation of lymph node metastases and the role of central versus peripheral arterial ligation of in rectal cancer specimens.
Read the detailed description
Prospective population-based study of specimens from patients that underwent surgical resection for rectal cancer in Västmanland County, Sweden. Specimens were divided in 3 sections (A-C) and the total amount of lymph nodes and the location of lymph node metastases were analysed.
Multivariate analysis was used to explore the relationship between lymph node counts and age, gender, BMI, preoperative oncological treatment, type of surgery, tumour stage, vessel and specimen length.
- Conditions
- Lymph Node Metastases
- Keywords
- rectal cancer
- Medical subject headings
- Lymphatic Metastasis, Rectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph node metastases in rectal cancer
Analyses of number and location of lymph node metastases in rectal cancer
Measured: 2012-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study startJan 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymph Node 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Västmanland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catarina Tiselius, Region Västmanland
- Investigators
- Catarina Tiselius, MD, PhD, Principal investigator, Region Västmanland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314961
- Sponsor's protocol ID
- Dnr2013/099
- Status last verified
- Oct 2017
- First submitted
- 16 Oct 2017
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Localisation of Mesenteric Lymph Node Metastases and Role of Level of Arterial Ligation in Rectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT03314961
- Acronym / sponsor ID
- Dnr2013/099
- Conditions
- Lymph Node Metastases
- Keywords
- rectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Region VästmanlandUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Oct 2017 (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.
Lymph node status is of major prognostic importance in non-metastatic rectal cancer. For oncological reasons, central arterial ligation of the inferior mesenteric artery (IMA) is suggested. However, there is no conclusive evidence presented for this procedure.
This study aimed at investigating the localisation of lymph node metastases and the role of central versus peripheral arterial ligation of in rectal cancer specimens.
Detailed description
Prospective population-based study of specimens from patients that underwent surgical resection for rectal cancer in Västmanland County, Sweden. Specimens were divided in 3 sections (A-C) and the total amount of lymph nodes and the location of lymph node metastases were analysed.
Multivariate analysis was used to explore the relationship between lymph node counts and age, gender, BMI, preoperative oncological treatment, type of surgery, tumour stage, vessel and specimen length.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that were diagnosed with rectal cancer 2012-2016 in Västmanlands county.
Key inclusion criteria (1 listed)
- All patients that were curatively operated for rectal cancer in Västmanlands county 2012-2016.
Key exclusion criteria (1 listed)
- Patients that were not operated or had another type of cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lymph node metastases in rectal cancer
Time frame: 2012-2016
Analyses of number and location of lymph node metastases in rectal cancer
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 19 Oct 2017.
- 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.
Catarina Tiselius, MD, PhD principal investigator
Region Västmanland
Questions about this trial
What is this clinical trial studying?
An observational study of Lymph Node Metastases, run by Region Västmanland.
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 1 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 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Lymph node metastases in rectal cancer (time frame: 2012-2016). 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 19 Oct 2017.