Clinical trial · Observational
A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program
NCT02218801CI-TRIAL-00058794CLIMBcompletedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This prospective database has two main objectives; * to evaluate the complication rates, 30-day and 90-day mortality from different surgical strategies for unresectable, borderline resectable or initially unresectable liver metastasis from colorectal cancer. * to establish baseline quality parameters for different surgical strategies for unresectable, borderline and initially unresectable colorectal liver metastasis (CRLM) patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Carcinoma | Colorectal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evaluation of treatment for liver metastasis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Colorectal adenocarcinoma liver metastasis
- description
- Unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer
- interventionNames
- Other: Evaluation of treatment for liver metastasis
Primary outcomes (1)
- measure
- Number of post-operative complications
- timeFrame
- 1 year
Secondary outcomes (3)
- measure
- Overall survival after 2 years of follow-up
- timeFrame
- 3 years
- measure
- Progression free survival at 2 years
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * With histologically proven colorectal adenocarcinoma with liver metastasis. * With unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer assessed by a clinician or by a multi-disciplinary tumor board (MDT). * Unresectable is defined as no possibility of completely resecting all tumor due to size, location or number of deposits. * Borderline is defined as potentially operable but technically or biologically more challenging to resect as evaluated by the MDT. * Initially unresectable is defined as metastasis that have been down-sized after conversion chemotherapy and evaluated by the MDT to be resectable * discussed by a multidisciplinary team before surgery. * Participants of the MDT must include at least one liver surgeon, one radiologist and one oncologist. They will determine the resectability of the CRLM according to local practice. * With a possibility of a surgical procedure (resection with or without portal vein embolization, intraoperative local ablative technique or a combined approach) assessed during the MDT. * Age ≥ 18 years. * Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations. Exclusion Criteria: * Any psychological, familial, or sociological condition potentially hampering understanding of the research project. * Any other malignancy other than in situ carcinoma of the cervix or non-melanoma skin cancer (unless there has been a disease-free interval of at least 5 years)
References
Publications (0)
Data not yet available
No reference posted for this study.