Safe D3 Right Hemicolectomy for Cancer Through Multidetector Computed Tomography (MDCT) Angio
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| First Received Date ICMJE | May 9, 2011 | ||||||||
| Last Updated Date | January 25, 2013 | ||||||||
| Start Date ICMJE | May 2011 | ||||||||
| Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Number of additional lymph nodes removed through radical D3 resection [ Time Frame: 1 year ] [ Designated as safety issue: No ] The short term outcome of this study will compare number of lymph nodes removed, operating time and complications between the two groups. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01351714 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Disease free survival 2 and 5 years after initial surgery [ Time Frame: 5 years ] [ Designated as safety issue: No ] 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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Safe D3 Right Hemicolectomy for Cancer Through Multidetector Computed Tomography (MDCT) Angio | ||||||||
| Official Title ICMJE | Safe D3 Right Hemicolectomy for Cancer Through 3D MDCT Angiography Reconstruction | ||||||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Colon Cancer | ||||||||
| Intervention ICMJE | Procedure: D3 resection
Radical D3 resection of the right colon through the use of preoperative MDCT angiography |
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| Study Arm (s) | D3 resection
Radical D3 resection of the right colon through the use of preoperative MDCT angiography
Intervention: Procedure: D3 resection |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 231 | ||||||||
| Estimated Completion Date | May 2017 | ||||||||
| Estimated Primary Completion Date | May 2015 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 20 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Norway | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01351714 | ||||||||
| Other Study ID Numbers ICMJE | D3 MDCT angio | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Dejan Ignjatovic, University Hospital, Akershus | ||||||||
| Study Sponsor ICMJE | Sykehuset i Vestfold HF | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Sykehuset i Vestfold HF | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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