NCT05665322

Evaluation of the Efficacy of Two Guidance Techniques (Standard Injected CT vs Porto-scanner With Angio-CT) for Thermoablation Treatment of Colorectal Cancer Liver Metastases

Translate Title: Evaluation of the Efficacy of Two Guidance Techniques (Standard Injected CT vs Porto-scanner With Angio-CT) for Thermoablation Treatment of Colorectal Cancer Liver Metastases: Randomized, Single-blind, Controlled Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hepatic metastases of colorectal cancer (CRC) are partially necrotic tumors mainly vascularized by the hepatic artery. When resectable, these metastases must be removed with a safety margin of 1 mm. Resection margins greater than 1 cm are associated with better disease-free survival and no local recurrence. Thermoablation systems allow for ablation zones of approximately 4.5-5 cm in diameter. For tumors \<3 cm, subject to perfect targeting, it is possible to obtain ablation margins of 1 cm, which would greatly reduce the local recurrence rate. Accurate assessment of these tumor boundaries and characterization of these margins are paramount to ensure complete ablation. Thermoablation for these small liver metastases (\<3cm) has shown equivalent efficacy to surgery in terms of recurrence and survival with fewer complications. Thermoablation treatment is indicated for patients with stable disease undergoing chemotherapy. This leads to liver remodeling and metastases become difficult to see on ultrasound and CT scans. The study authors hypothesize that the porto-scanner guidance technique with Angio-CT for thermoablation treatment of CRC liver metastases will allow a better exploration of these metastases by allowing a better identification of the margins and thus ensure a more accurate and complete treatment for patients.

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
PROCEDURE	Thermoablation with standard CT guidance	Guidance with small volume breathing and high frequency. The contrast product will be venously injected in the elbow.
PROCEDURE	Thermoablation with porto-scanner guidance with Angio-CT	Real time guidance, small volume and high frequency respiration. Contrast medium will be directly injected into the superior mesenteric artery (SMA) after puncture of the femoral artery at the inguinal fold and catheterization of the SMA.

Timeline

• Start date: 2024-02-27
• Primary completion: 2025-10-09
• Completion: 2025-10-09
• First posted: 2022-12-27
• Last updated: 2026-01-23

Locations

2 sites across 1 country: France