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Early detection of hepatic metastasis in follow-up high-risk colorectal carcinoma

Recruiting
Conditions
Early detection of hepatic metastasis in follow-up high-risk colorectal carcinoma
Registration Number
NL-OMON20752
Lead Sponsor
oordwest Ziekenhuisgroep Wilhelminalaan 12 1815 JD Alkmaar
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
174
Inclusion Criteria

In order to be eligible to participate in this study, patients must meet all of the following criteria:
- Patients 18-80 years with pT1-4 N1/2 M0 colorectal carcinoma
- WHO performance score 0 or 1
- Being able to give informed consent and to manage the Dutch language (given the
questionnaires)

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Claustrophobia
- MRI incompatible devices
- Age > 80 years
- Not mastering the Dutch language (given the questionnaires)
- Pregnancy and lactation

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. To investigate if follow-up of asymptomatic patients with high-risk colorectal carcinoma with reduced protocol MRI liver instead of US will affect the time to diagnosis recurrent liver metastasis (LM-2) in months starting from postoperative control (=randomization); TRLM.
Secondary Outcome Measures
NameTimeMethod
To investigate if follow-up of asymptomatic patients with high-risk colorectal carcinoma with reduced protocol MRI liver instead of US will affect:<br>2. Time to diagnosis of first liver metastasis (LM-1) in months starting from postoperative control (=randomization); TFLM.<br>3. Time between first postoperative control and diagnosis of first liver metastasis (LM-1); liver metastasis free survival 1 (LMFS-1).<br>4. Time between diagnosis LM-1 and diagnosis LM-2 in months; liver metastasis free survival 2 (LMFS-2).<br>5. The proportion of patients who are potentially eligible for curative therapy when detecting<br>LM-1.<br>6. 5 year survival.<br>7. Anxiety and quality of life.<br>8. To compare sensitivity and specificity for detection of liver metastasis between US and reduced MRI liver protocol.
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