NCT07564284Not yet recruiting
Liver-First, Bowel-First, or Simultaneous Resection for Synchronous Colorectal Liver Metastases: Outcomes, Quality of Life, and Cost-Effectiveness
Optimizing Treatment of Synchronous Colorectal Liver Metastases - Creation of a Treatment Algorithm
Source: ClinicalTrials.gov · Last updated 4 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 27 Apr 2026
- Start date
- 1 May 2026
- Primary completion date
- 31 May 2028
- Lead sponsor
- Karolinska Institutet
- Diseases
- Colorectal cancer
- NCT number
- NCT07564284
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 May 2026 to the primary completion date, 31 May 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Not scheduled for curative resection of both the primary tumor and liver metastases
- Emergency resection of the primary tumor performed prior to MDT referral
Other
- Unable to give informed consent (Studies 4-6 only; opt-out applies to Study 3)
- Untreatable extrahepatic metastases at the discretion of the MDT
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.