Safe D3 Right Hemicolectomy for Cancer Through Multidetector Computed Tomography (MDCT) Angio
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Colon Cancer |
Procedure: D3 resection |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safe D3 Right Hemicolectomy for Cancer Through 3D MDCT Angiography Reconstruction |
- 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.
- 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.
| Estimated Enrollment: | 231 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | May 2017 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
D3 resection
Radical D3 resection of the right colon through the use of preoperative MDCT angiography
|
Procedure: D3 resection
Radical D3 resection of the right colon through the use of preoperative MDCT angiography
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Dejan Ignjatovic, MD, PhD | +4746681797 | dexexer01@hotmail.com |
| Contact: Bojan Stimec, MD, PhD | bojan.stimec@gmail.com |
| Norway | |
| Haukeland University Hospital | Recruiting |
| Bergen, Norway, 5021 | |
| Contact: Frank Pfeffer, Prof frank.pfeffer@helse-bergen.no | |
| Akershus University Hospital | Recruiting |
| Lorenskog, Norway, 1478 | |
| Contact: Dejan Ignjatovic, MD, PhD dexexer01@hotmail.com | |
| Sub-Investigator: Mohammad Shafique, MD | |
| Vestfold Hospital Trust | Recruiting |
| Tonsberg, Norway, 3103 | |
| Contact: Jens Marius Nesgaard, MD jens.marius.nesgaard@siv.no | |
More Information
No publications provided
| Responsible Party: | Dejan Ignjatovic, MD, PhD, University Hospital, Akershus |
| ClinicalTrials.gov Identifier: | NCT01351714 History of Changes |
| Other Study ID Numbers: | D3 MDCT angio |
| Study First Received: | May 9, 2011 |
| Last Updated: | January 25, 2013 |
| Health Authority: | Norway: Regional Ethics Commitee |
Keywords provided by Sykehuset i Vestfold HF:
|
D3 resection right colectomy MDCT angiography lymphadenectomy |
safe right colon preoperative |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013