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

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ClinicalTrials.gov Identifier: NCT01351714
Recruitment Status : Recruiting
First Posted : May 11, 2011
Last Update Posted : April 27, 2017
Information provided by (Responsible Party):

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
Colon Cancer Procedure: D3 resection

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  (Clinical Trial)
Estimated Enrollment : 700 participants
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 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020
Arms and Interventions

Arm Intervention/treatment
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 :
  1. 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.

Secondary Outcome Measures :
  1. Disease free survival 2 and 5 years after initial surgery [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351714

Contact: Dejan Ignjatovic, MD, PhD +4746681797 dexexer01@hotmail.com
Contact: Bojan Stimec, MD, PhD bojan.stimec@gmail.com

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   
Sponsors and Collaborators
Sykehuset i Vestfold HF
University Hospital, Akershus
Haukeland University Hospital
Konya Training and Research Hospital
University of Geneva, Switzerland
More Information

Responsible Party: Dejan Ignjatovic, MD, PhD, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT01351714     History of Changes
Other Study ID Numbers: D3 MDCT angio
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by Dejan Ignjatovic, University Hospital, Akershus:
D3 resection
right colectomy
MDCT angiography
right colon