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

Completed

• Conditions: liver metastasis; 10019815; 10027476

• Registration Number: NL-OMON48841
• Lead Sponsor: oordwest Ziekenhuisgroep

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 174

Inclusion Criteria

High risk colorectal carcinoma

Exclusion Criteria

- 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

Name	Time	Method
<p>Primary study parameter/endpoint<br /><br><br /><br>1. Time to diagnosis recurrent liver metastasis (LM-2) in months starting from<br /><br>postoperative control (=randomization);TRLM. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters/endpoints<br /><br><br /><br>2. Time to diagnosis of first liver metastasis (LM-1) in months starting from<br /><br>postoperative control (= randomization);TFLM.<br /><br>3. Time between first postoperative control and diagnosis of first liver<br /><br>metastasis (LM-1); liver metastasis free survival 1 (LMFS-1).<br /><br>4. Time between diagnosis LM-1 and diagnosis LM-2 in months; liver metastasis<br /><br>free survival 2 (LMFS-2).<br /><br><br /><br>5. The proportion of patients who are potentially eligible for curative therapy<br /><br>when detecting LM-1.<br /><br>6. 5 year survival.<br /><br>7. Anxiety and quality of life (HADS-A (anxiety score), SF-36 (QOL), QLQ-C30).<br /><br><br /><br>8. Sensitivity and specificity of both US as reduced MRI liver protocol for<br /><br>detection of liver metastasis. </p><br>