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Endoscopic Ultrasound and Contrast Enhancement for Staging and Evaluation of Angiogenesis of Left Sided Colon Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02324023
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : November 29, 2016
Herlev Hospital
Information provided by (Responsible Party):
Zealand University Hospital

Brief Summary:

Cancer in the colon and rectum represents a global health burden being the most common cancer of the digestive tract. It is the second most common cancer in Denmark and only about half of the patients survive this diagnosis. Thorough characterization of the tumour preoperatively is very important, since it determines if the patient should be treated with chemotherapy before operation and, in the future, which operation would be most suitable for the patient.

Research has shown that endoscopic ultrasound (EUS) is superior to a CT-scan, in determining the local growth of the tumour in rectal cancer. Today, a CT-scan is the image modality of choice, and is used in all Danish hospitals when it comes to colon cancer. Hopefully, the investigators can apply EUS in colon cancer patients and thereby alter our diagnostic approach, towards a quicker and safer way to determine which treatment the investigators should offer the patient.

With the screening programme for colorectal cancer in Denmark the investigators will find more and more cases of colorectal cancers, especially in the early stages, before symptoms begin. These small tumours put doctors in several dilemmas concerning the strategy of treatment. Even today, the investigators are very reluctant in offering large-scale operations to elderly and fragile patients who have been diagnosed with cancer in the rectum. Instead, local endoscopic operations are performed in selected patients. This approach has not yet been tried in early colonic cancers. However, it might turn out that local, endoscopic surgery will show to be beneficial for patients with colon cancers and maybe even decrease morbidity, mortality and the regenerative period after surgery.

The aim of this PhD-project is to investigate the utility of the EUS-method in characterizing tumours in the colon and in investigating the blood flow in the tumour.

Condition or disease Intervention/treatment Phase
Colonic Neoplasms Device: Endoscopic ultrasound Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Endoscopic Ultrasound Scanning and Contrast Enhancement for Staging and Evaluation of Angiogenesis of Left Sided Colon Cancers
Study Start Date : November 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Ultrasound

Arm Intervention/treatment
Experimental: Endoscopic ultrasound and pathology
Endoscopic ultrasound and contrast enhanced endoscopic ultrasound for staging and perfusion (preoperatively) compared to pathological stage and vessel density in the pathological specimen (postoperatively).
Device: Endoscopic ultrasound
All patients will be evaluated by EUS and CE-EUS, using radial EUS instruments. The EUS scope will be inserted under direct vision, passed by the tumour and examination should begin during withdrawal at 7.5 MHz. The tumour will be characterized describing its echogenicity, echo structure, size, extent into the bowel wall and surrounding structures, and it will be staged using the modification of the TNM classification, based on a five-layer intestinal wall model. The presence/absence of power Doppler signals will be noted. For CE-EUS parameters for objective measurement of tumour perfusion will include maximum intensity of enhancement, mean transit time, time to peak (wash-in time), wash-in slope, area under the curve, representing indirectly blood flow or blood volume in CRC patients.
Other Name: Endoscopic ultrasonography

Primary Outcome Measures :
  1. T-stage in left sided colonic cancer determined by endoscopic ultrasound compared to histological stage [ Time Frame: EUS examination, 10 min ]
    EUS stage compared to histological stage and CT scan stage

Secondary Outcome Measures :
  1. Perfusion in left sided colonic cancer determined by contrast enhanced endoscopic ultrasound compared to histological vascular immunostaining [ Time Frame: CE-EUS examination, 5 min ]
    Endoscopic ultrasound perfusion parameters correlated to histopathological vascular characteristics of left-sided colonic cancers

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients planned for elective left-sided colon cancer surgery
  • Age 18 to 100 years old, men or women
  • Signed informed consent for EUS with contrast-enhancement

Exclusion Criteria:

  • Prior treatment with chemo-radiotherapy (before the diagnosis of colon cancer)
  • Prior endoscopic resection or attempted endoscopic resection (before the diagnosis of colon cancer, but in the same area as the cancer)
  • Pregnant women
  • Failure to provide informed consent
  • Severe coagulopathy

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 identifier (NCT number): NCT02324023

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Herlev Hospital
Herlev, Denmark, 2730
Roskilde Hospital
Roskilde, Denmark, 4000
Sponsors and Collaborators
Zealand University Hospital
Herlev Hospital
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Study Director: Peter Vilmann, MD, DMSc Herlev Hospital
Unable to connect to PubMed to validate , last attempt on November 19, 2014 at 10:31 AM EST

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Zealand University Hospital Identifier: NCT02324023    
Other Study ID Numbers: H-4-2014-075
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zealand University Hospital:
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases