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

September 27, 2020 updated by: Dejan Ignjatovic, Sykehuset i Vestfold HF

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

700

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset i Vestfold HF

Collaborators

University Hospital, Akershus
University of Geneva, Switzerland
Konya Meram State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Anticipated)

January 1, 2021

Study Completion (Anticipated)

January 1, 2021

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

May 10, 2011

First Posted (Estimate)

May 11, 2011

Study Record Updates

Last Update Posted (Actual)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 27, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D3 MDCT angio

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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