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

Sponsor

Sykehuset i Vestfold HF (Other)

Overall Status

Recruiting

CT.gov ID

NCT01351714

Collaborator

Konya Meram State Hospital (Other), University of Geneva, Switzerland (Other), University Hospital, Akershus (Other)

700

Enrollment

Locations

Arm

116.1

Duration (Months)

350

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer	Procedure: D3 resection	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

700 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Outcome Measures

Primary Outcome Measures

Number of additional lymph nodes removed through radical D3 resection [1 year]
The short term outcome of this study will compare number of lymph nodes removed, operating time and complications between the two groups.

Secondary Outcome Measures

Disease free survival 2 and 5 years after initial surgery [5 years]
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.