Simultaneous vs. Staged Resection of Colorectal Cancer With Synchronous Liver Metastases - A Multicentre Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The SYLMET Trial is a randomized trial to compare simultaneous and two-staged resection of primary colorectal and synchronous liver metastases. This is an investigator-initiated, multicentre, randomized controlled trial to assess complications (primary endpoint), survival, cost-effectiveness, and quality of life (secondary endpoints).This trial will include patients with resectable primary tumour in the colon or upper rectum with less than five liver metastases that is possible to treat with surgical resection and/or ablation (RFA/MWA) at time of evaluation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age 18-80 years old.

• Both CRC and liver metastases in situ at time of evaluation.

• Resectable primary tumor in the colon or upper rectum.

• Less than 5 liver metastases, evaluated by the multidisciplinary tumor board meeting as possible to treat with surgical resection and/or ablation (RFA/MWA).

Locations
Other Locations
Norway
Oslo University Hospital
RECRUITING
Oslo
Contact Information
Primary
Sheraz Yaqub, MD PhD
shya@ous-hf.no
+47-23073296
Backup
Frida B Hansen
frbhan@ous-hf.no
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 80
Treatments
Active_comparator: Staged resection
Resection of the primary colorectal carcinoma and liver metastases in two separate surgeries.
Experimental: Simultaneous resection
Resection of both the primary colorectal carcinoma and the liver metastases in one surgical procedure.
Related Therapeutic Areas
Sponsors
Collaborators: St. Olavs Hospital, Haukeland University Hospital, University of Oslo, Helse Stavanger HF, University Hospital, Akershus
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov

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