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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Sykehuset i Vestfold HF
Sponsor:
Collaborators:
University Hospital, Akershus
Haukeland University Hospital
Konya Research and Training Hospital, Turkey
Faculty of Medicine, Anatomy sector, University of Geneva, Switzerland
Information provided by (Responsible Party):
Dejan Ignjatovic, University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT01351714
First received: May 9, 2011
Last updated: November 17, 2014
Last verified: November 2014
  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

Resource links provided by NLM:


Further study details as provided by Sykehuset i Vestfold HF:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351714

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

Locations
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   
Sponsors and Collaborators
Sykehuset i Vestfold HF
University Hospital, Akershus
Haukeland University Hospital
Konya Research and Training Hospital, Turkey
Faculty of Medicine, Anatomy sector, University of Geneva, Switzerland
  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: November 17, 2014
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by Sykehuset i Vestfold HF:
D3 resection
right colectomy
MDCT angiography
lymphadenectomy
safe
right colon
preoperative

ClinicalTrials.gov processed this record on November 20, 2014