Colon CancerNCT01351714
Safe D3 Right Hemicolectomy for Cancer Through Multidetector Computed Tomography (MDCT) Angio
A study testing D3 resection in people with Colon Cancer, run by Sykehuset i Vestfold HF at 2 sites in Norway.
Trial summary
When performing a resection of the right colon due to cancer one aims not only to remove the tumor bearing bowel segment, but also lymph nodes draining the affected area. These lymph nodes are located along the arteries supplying the right colon. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- D3 resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 2 sitesNorway
- Study dates
- May 2011to Jan 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histo-pathologically verified adeno-carcinoma of the right colon
- Patients under the age of 75
- Patients medically cleared by anesthesiologist for general anesthesia
- Signed informed consent form
Who cannot join
- Patients with recurrent cancer after previous surgery
- Patients with distant metastasis
- Patients who are not medically cleared to undergo anesthesia
- Patients who do not sign the informed consent form
Trial locations and contacts
2 sites in 1 country.
Bojan Stimec, MD, PhD contact
Norway2 sites, 2 recruiting
- Recruiting
Akershus University Hospital
Lorenskog, 1478
Dejan Ignjatovic, MD, PhD, dexexer01@hotmail.com
- Recruiting
Vestfold Hospital Trust
Tønsberg, 3103
Jens Marius Nesgaard, MD, jens.marius.nesgaard@siv.no
About this study
Official title: Safe D3 Right Hemicolectomy for Cancer Through 3D MDCT Angiography Reconstruction
When performing a resection of the right colon due to cancer one aims not only to remove the tumor bearing bowel segment, but also lymph nodes draining the affected area. These lymph nodes are located along the arteries supplying the right colon. Through using a preoperative CT scan which can map these arteries very precisely one can ligate these vessels closer to their origin and thus remove more lymph nodes which may potentially harbor cancer cells. This study aims to compare patients operated more radically through use of preoperative CT which maps the mentioned arteries with patients operated in the standard way.
Read the detailed description
The Norwegian gastrointestinal cancer group has recommended D3 resection as the standard operative technique for colon cancer. D3 resection implies ligation of the blood vessels at their origin. There is evidence that the recurrence free period and survival improves with the number of lymph nodes harvested at surgery. However, the current practice in Norway, while performing right hemicolectomy for cancer is to ligate the feeding vessels for the right colon on the right hand side of the superior mesenteric vein (SMV). Significant arterial stumps have been demonstrated in patients operated for right colon cancer with this technique (right colic artery and ileocolic artery vascular stumps with an average length of 3.5 cm and 2.5 cm, respectively). This leaves reason to believe that a certain number of central lymph nodes remain after the procedure.
The complex anatomical relationship between the right colic artery and ileocolic artery with the superior mesenteric vein make D3 resection demanding, especially if the right colic artery lies posterior to the SMV. These relationships are investigated in detail in postmortem anatomical studies. These studies show that the right colic artery lies most often anterior to the SMV, while the ileocolic artery lies most often posterior to the SMV. Data has also been provided that a CT angiography can verify these relations as well as postmortem anatomical studies in living patients, thus allowing the surgeon to be aware of them prior to surgery. This could prove to be crucial in planning the procedure.
- Conditions
- Colon Cancer
- Being tested
- D3 resection
- Keywords
- D3 resection, right colectomy, MDCT angiography, lymphadenectomy, safe, right colon, preoperative
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D3 resectionProcedure or surgery
Radical D3 resection of the right colon through the use of preoperative MDCT angiography
| Study group | Role | What they receive |
|---|---|---|
| D3 resection | Other | Radical D3 resection of the right colon through the use of preoperative MDCT angiography Receives: Procedure: D3 resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of additional lymph nodes removed through radical D3 resection
The short term outcome of this study will compare number of lymph nodes removed, operating time and complications between the two groups.
Measured: 1 year
Secondary outcomes (1)
Disease free survival 2 and 5 years after initial surgery
One will compare disease free survival at 2 and 5 years between the two groups to see if those more radically operated through D3 resection will have better outcomes.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startMay 2011
- Primary completionJan 2021 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sykehuset i Vestfold HF
- Sponsor type
- University, hospital or other
- Collaborators
- Konya Meram State Hospital, University of Geneva, Switzerland, University Hospital, Akershus
- Responsible party
- Principal investigator, Dejan Ignjatovic, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351714
- Sponsor's protocol ID
- D3 MDCT angio
- Status last verified
- Sep 2020
- First submitted
- 9 May 2011
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Banipal GS, Stimec BV, Andersen SN, Faerden AE, Edwin B, Baral J, Nesgaard JM, Benth JS, Ignjatovic D; R. C. C. study group. Comparing 5-Year Survival Rates Before and After Re-stratification of Stage I-III Right-Sided Colon Cancer Patients by Establishing the Presence/Absence of Occult Tumor Cells and Lymph Node Metastases in the Different Levels of Surgical Dissection. J Gastrointest Surg. 2022 Oct;26(10):2201-2211. doi: 10.1007/s11605-022-05434-6. Epub 2022 Aug 29.
PubMed 36036877Banipal GS, Stimec BV, Andersen SN, Faerden AE, Edwin B, Baral J, Benth JS, Ignjatovic D; RCC study group. Interactions of occult tumor spread and surgical technique on overall and disease-free survival in patients operated for stage I and II right-sided colon cancer. J Cancer Res Clin Oncol. 2021 Dec;147(12):3535-3543. doi: 10.1007/s00432-021-03773-6. Epub 2021 Aug 24.
PubMed 34427788
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe D3 Right Hemicolectomy for Cancer Through 3D MDCT Angiography Reconstruction
- ClinicalTrials.gov ID
- NCT01351714
- Acronym / sponsor ID
- D3 MDCT angio
- Conditions
- Colon Cancer
- Keywords
- D3 resection, right colectomy, MDCT angiography, lymphadenectomy, safe, right colon, preoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Sykehuset i Vestfold HFUniversity, hospital or other
- Collaborators
- Konya Meram State Hospital, University of Geneva, Switzerland, University Hospital, Akershus
- Study start
- May 2011
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 11 May 2011 (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.
When performing a resection of the right colon due to cancer one aims not only to remove the tumor bearing bowel segment, but also lymph nodes draining the affected area. These lymph nodes are located along the arteries supplying the right colon. Through using a preoperative CT scan which can map these arteries very precisely one can ligate these vessels closer to their origin and thus remove more lymph nodes which may potentially harbor cancer cells. This study aims to compare patients operated more radically through use of preoperative CT which maps the mentioned arteries with patients operated in the standard way.
Detailed description
The Norwegian gastrointestinal cancer group has recommended D3 resection as the standard operative technique for colon cancer. D3 resection implies ligation of the blood vessels at their origin. There is evidence that the recurrence free period and survival improves with the number of lymph nodes harvested at surgery. However, the current practice in Norway, while performing right hemicolectomy for cancer is to ligate the feeding vessels for the right colon on the right hand side of the superior mesenteric vein (SMV). Significant arterial stumps have been demonstrated in patients operated for right colon cancer with this technique (right colic artery and ileocolic artery vascular stumps with an average length of 3.5 cm and 2.5 cm, respectively). This leaves reason to believe that a certain number of central lymph nodes remain after the procedure.
The complex anatomical relationship between the right colic artery and ileocolic artery with the superior mesenteric vein make D3 resection demanding, especially if the right colic artery lies posterior to the SMV. These relationships are investigated in detail in postmortem anatomical studies. These studies show that the right colic artery lies most often anterior to the SMV, while the ileocolic artery lies most often posterior to the SMV. Data has also been provided that a CT angiography can verify these relations as well as postmortem anatomical studies in living patients, thus allowing the surgeon to be aware of them prior to surgery. This could prove to be crucial in planning the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| D3 resection | Other | Procedure: D3 resectionRadical D3 resection of the right colon through the use of preoperative MDCT angiography |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with histo-pathologically verified adeno-carcinoma of the right colon
- Patients under the age of 75
- Patients medically cleared by anesthesiologist for general anesthesia
- Signed informed consent form
Key exclusion criteria (4 listed)
- Patients with recurrent cancer after previous surgery
- Patients with distant metastasis
- Patients who are not medically cleared to undergo anesthesia
- Patients who do not sign the informed consent form
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 |
|---|---|---|
| D3 resectionRadical D3 resection of the right colon through the use of preoperative MDCT angiography | Procedure or surgery | D3 resection |
Primary outcome
Number of additional lymph nodes removed through radical D3 resection
Time frame: 1 year
The short term outcome of this study will compare number of lymph nodes removed, operating time and complications between the two groups.
1 secondary outcome
Disease free survival 2 and 5 years after initial surgery
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Derived from this study: PubMed 36036877Banipal GS, Stimec BV, Andersen SN, Faerden AE, Edwin B, Baral J, Nesgaard JM, Benth JS, Ignjatovic D; R. C. C. study group. Comparing 5-Year Survival Rates Before and After Re-stratification of Stage I-III Right-Sided Colon Cancer Patients by Establishing the Presence/Absence of Occult Tumor Cells and Lymph Node Metastases in the Different Levels of Surgical Dissection. J Gastrointest Surg. 2022 Oct;26(10):2201-2211. doi: 10.1007/s11605-022-05434-6. Epub 2022 Aug 29.
- Derived from this study: PubMed 34427788Banipal GS, Stimec BV, Andersen SN, Faerden AE, Edwin B, Baral J, Benth JS, Ignjatovic D; RCC study group. Interactions of occult tumor spread and surgical technique on overall and disease-free survival in patients operated for stage I and II right-sided colon cancer. J Cancer Res Clin Oncol. 2021 Dec;147(12):3535-3543. doi: 10.1007/s00432-021-03773-6. Epub 2021 Aug 24.
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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.
Bojan Stimec, MD, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing D3 resection in people with Colon Cancer, run by Sykehuset i Vestfold HF at 2 sites in Norway.
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 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: status not confirmed, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
Contact Dejan Ignjatovic, MD, PhD (+4746681797, dexexer01@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of additional lymph nodes removed through radical D3 resection (time frame: 1 year). 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 NCT01351714, which also lists 2 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 30 Sep 2020.