Endoscopic Ultrasound and Contrast Enhancement for Staging and Evaluation of Angiogenesis of Left Sided Colon Cancers
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|ClinicalTrials.gov Identifier: NCT02324023|
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : November 29, 2016
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
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): NCT02324023
|Herlev, Denmark, 2730|
|Roskilde, Denmark, 4000|
|Study Director:||Peter Vilmann, MD, DMSc||Herlev Hospital|