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

NCT02324023 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2016-11-29

No results posted yet for this study

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.

Conditions

  • Colonic Neoplasms

Interventions

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.

Sponsors & Collaborators

  • Herlev Hospital

    collaborator OTHER

  • Zealand University Hospital

    lead OTHER

Principal Investigators

  • Peter Vilmann, MD, DMSc · Herlev Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-01-31
Completion
2016-11-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02324023 on ClinicalTrials.gov