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Trial record 97 of 1010 for:    colon cancer AND resection

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 : May 9, 2019
Sponsor:
Collaborators:
University Hospital, Akershus
Haukeland University Hospital
Konya Training and Research Hospital
University of Geneva, Switzerland
Information provided by (Responsible Party):
Dejan Ignjatovic, University Hospital, Akershus

Tracking Information
First Submitted Date  ICMJE May 9, 2011
First Posted Date  ICMJE May 11, 2011
Last Update Posted Date May 9, 2019
Study Start Date  ICMJE May 2011
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01351714 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2011)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safe D3 Right Hemicolectomy for Cancer Through Multidetector Computed Tomography (MDCT) Angio
Official Title  ICMJE Safe D3 Right Hemicolectomy for Cancer Through 3D MDCT Angiography Reconstruction
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE Procedure: D3 resection
Radical D3 resection of the right colon through the use of preoperative MDCT angiography
Study Arms  ICMJE D3 resection
Radical D3 resection of the right colon through the use of preoperative MDCT angiography
Intervention: Procedure: D3 resection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 26, 2017)
700
Original Estimated Enrollment  ICMJE
 (submitted: May 10, 2011)
49
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dejan Ignjatovic, MD, PhD +4746681797 dexexer01@hotmail.com
Contact: Bojan Stimec, MD, PhD bojan.stimec@gmail.com
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01351714
Other Study ID Numbers  ICMJE D3 MDCT angio
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dejan Ignjatovic, University Hospital, Akershus
Study Sponsor  ICMJE Sykehuset i Vestfold HF
Collaborators  ICMJE
  • University Hospital, Akershus
  • Haukeland University Hospital
  • Konya Training and Research Hospital
  • University of Geneva, Switzerland
Investigators  ICMJE Not Provided
PRS Account Sykehuset i Vestfold HF
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP