Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Metastases From Colorectal Cancer | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Synchronous colorectal liver metastases
- description
- Simultaneous Resection, Bowel-First Staged Resection, Liver-First Staged Resection
Primary outcomes (1)
- measure
- Failure to Return to Intended Oncological Treatment (RIOT)
- timeFrame
- From date of MDT discussion to completion of intended treatment, assessed up to 24 months.
- description
- The proportion of patients who do not complete their planned surgical treatment pathway, and the reasons for failure. In staged resections, this most commonly occurs when disease progression during the interval between operations renders the second operation unfeasible.
Secondary outcomes (9)
- measure
- Overall Survival
- timeFrame
- Time frame: 3 and 5 years from diagnosis
- description
- Survival assessed from the date of diagnosis of the primary colorectal tumor
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available