A Randomized Controlled Trial of Needle Ablation With 3D Verification vs Surgical Resection of Colorectal Cancer Liver Metastases

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

230 patients with colorectal cancer liver metastases will be randomly assigned to resection or thermal ablation.

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

• Histologically verified colorectal cancer

• Colorectal liver metastases (proven or suspected) eligible for radical treatment using EITHER resection OR ablation (not a combination), as decided by the liver MDT meeting at the study center

• The patient is fit to undergo both resection and ablation of all liver metastases

• Size of largest lesion up to and including 30 mm

• In case of solitary metastasis, resection plan includes resection of ≤ 2 anatomical segments.

• In case of multiple metastases in one continuous resection, resection plan can include ≤ 4 anatomical segments (including hemihepatectomy)

• ≤ 5 tumors to be treated in one procedure

• Primary tumor either resected (primary first) or with a plan for curative treatment (liver first).

Locations
Other Locations
Norway
Oslo University Hospital, Department of Gastrointestinal surgery, The National Hospital
RECRUITING
Oslo
Contact Information
Primary
Åsmund A Fretland, MD PhD
aasmund@fretland.no
004723070100
Backup
Bjørn Edwin, Professor
bjoedw@ous-hf.no
004793008635
Time Frame
Start Date: 2021-12-16
Estimated Completion Date: 2025-12
Participants
Target number of participants: 230
Treatments
Active_comparator: Surgical resection
Liver resection
Experimental: Thermal ablation
Thermal ablation (Microwave or radiofrequency)
Related Therapeutic Areas
Sponsors
Leads: Oslo University Hospital

This content was sourced from clinicaltrials.gov