Liver-First, Bowel-First, or Simultaneous Resection for Synchronous Colorectal Liver Metastases: Outcomes, Quality of Life, and Cost-Effectiveness
Starting soon
Conditions studied: Liver Metastases From Colorectal Cancer
In brief
The goal of this observational study is to learn about treatment outcomes, quality of life, and healthcare costs in patients with colorectal cancer who have liver metastases detected at the same time as their primary tumor (synchronous colorectal liver metastases, CRLM). The main questions it aims to answer are: Do patients who undergo simultaneous removal of both the bowel tumor and liver metastases in one operation differ in their ability to complete the intended treatment compared to patients who undergo staged operations (bowel first or liver first)? Does the choice of surgical strategy affect quality of life and healthcare costs? Patients with synchronous CRLM discussed at a multidisciplinary team meeting at participating Swedish university hospitals will be followed prospectively for up to 5 years. Treatment is not influenced by the study - all surgical decisions are made as part of routine clinical care. Patients in the quality-of-life sub-study will complete validated questionnaires (EORTC QLQ-C30, QLQ-LM21, and QLQ-CR29) at multiple time points from diagnosis through 36 months. Healthcare costs and health literacy will also be assessed in parallel sub-studies.
Key facts
- Study ID
- NCT07564284
- Run by
- Karolinska Institutet
- People needed
- 200
- Starts
- 2026-05-01
- Expected to finish
- 2029-05-01
- Last updated by the study team
- 2026-05-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age over 18 years
- Histologically proven colorectal cancer
- Radiological evidence of liver metastases (contrast-enhanced CT or MRI), detected prior to resection of the primary colorectal tumor
- Primary colorectal tumor (colon or rectum) in situ at time of inclusion
- Discussed at a hepatobiliary and/or colorectal multidisciplinary team (MDT) meeting
- Planned curative treatment of both the primary colorectal tumor AND the liver metastases (by resection, ablation, or transplantation)
- Planned curative treatment of any extrahepatic disease, if present
You may not qualify if…
- Unable to give informed consent (Studies 4-6 only; opt-out applies to Study 3)
- Untreatable extrahepatic metastases at the discretion of the MDT
- Not scheduled for curative resection of both the primary tumor and liver metastases
- Emergency resection of the primary tumor performed prior to MDT referral
Full record on ClinicalTrials.gov
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