Safe D3 Right Hemicolectomy for Cancer Through Multidetector Computed Tomography (MDCT) Angio

Colon Cancer Clinical Trial

Official title:

Safe D3 Right Hemicolectomy for Cancer Through 3D MDCT Angiography Reconstruction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01351714
• Other study ID #: D3 MDCT angio
• Status: Recruiting
• Phase: N/A
• Start date: May 2011
• Est. completion date: January 2021

Study information

• Verified date: September 2020
• Source: Sykehuset i Vestfold HF
• Contact: Dejan Ignjatovic, MD, PhD
• Phone: +4746681797
• Email: dexexer01[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

Procedure:
• D3 resection
Radical D3 resection of the right colon through the use of preoperative MDCT angiography

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lorenskog
Norway	Vestfold Hospital Trust	Tonsberg

Sponsors (4)

Lead Sponsor	Collaborator
Sykehuset i Vestfold HF	Konya Training and Research Hospital, University Hospital, Akershus, University of Geneva, Switzerland

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	5 years