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

NCT02324023 | Completed DMC

• 1 other identifier: H-4-2014-075
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Colonic Neoplasms

Keywords

ultrasound; perfusion; endoscopic

Outcome Measures

Primary Outcomes (1)

• T-stage in left sided colonic cancer determined by endoscopic ultrasound compared to histological stage

  EUS stage compared to histological stage and CT scan stage

  EUS examination, 10 min

Secondary Outcomes (1)

• Perfusion in left sided colonic cancer determined by contrast enhanced endoscopic ultrasound compared to histological vascular immunostaining

  CE-EUS examination, 5 min

Study Arms (1)

Endoscopic ultrasound and pathology

EXPERIMENTAL

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

Interventions

Endoscopic ultrasound DEVICE

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.

Also known as: Endoscopic ultrasonography

Endoscopic ultrasound and pathology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead
• Herlev Hospital: collaborator

Study Sites (2)

Herlev Hospital

Herlev, 2730, Denmark

Location

Roskilde Hospital

Roskilde, 4000, Denmark

Location

Related Publications (3)

• Unable to connect to PubMed to validate , last attempt on November 19, 2014 at 10:31 AM EST

  BACKGROUND

• Malmstrom ML, Saftoiu A, Riis LB, Hassan H, Klausen TW, Rahbek MS, Gogenur I, Vilmann P. Dynamic contrast-enhanced EUS for quantification of tumor perfusion in colonic cancer: a prospective cohort study. Gastrointest Endosc. 2018 Jun;87(6):1530-1538. doi: 10.1016/j.gie.2018.01.001. Epub 2018 Jan 9.

  PMID: 29329991 DERIVED

• Malmstrom ML, Gogenur I, Riis LB, Hassan H, Klausen TW, Perner T, Saftoiu A, Vilmann P. Endoscopic ultrasonography and computed tomography scanning for preoperative staging of colonic cancer. Int J Colorectal Dis. 2017 Jun;32(6):813-820. doi: 10.1007/s00384-017-2820-x. Epub 2017 Apr 21.

  PMID: 28432444 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Endosonography

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Peter Vilmann, MD, DMSc

  Herlev Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: December 24, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 29, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)