Ablation With Systemic Therapy vs Liver Resection With Systemic Therapy for Colorectal Liver Metastasis

NCT07559851 | Completed

• 1 other identifier: 2024-HS-142
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

For patients with colorectal liver metastases (CRLM) ≤5 cm, Clinical guidelines recommend surgery, but a growing number of studies have shown that thermal ablation is as effective as surgery. However, the optimal treatment strategy remains unclear.This study aimed to compare outcomes between patients who underwent ablation with systemic therapy or liver resection with systemic therapy for CRLM less than 5 cm in diameter.

Conditions

Colorectal Liver Metastasis (CRLM)

Keywords

Colorectal liver metastases; microwave ablation; progression-free survival

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Disease progression is defined as the appearance of metastatic tumors outside the liver or local recurrence or new tumors within the liver.The definition of Progression-Free Survival (PFS) is the time from the start of treatment to disease progression or death.

  1year

Study Arms (2)

AS

Patients who underwent ablation combined with systemic therapy for colorectal liver metastasis (CRLM) were included in the AS group.

Procedure: ablation combined with systemic therapy

RS

Patients who underwent liver resection combined with systemic therapy for colorectal liver metastasis (CRLM) were included in the RS group.

Procedure: liver resection combined with systemic therapy

Interventions

ablation combined with systemic therapy PROCEDURE

ltrasound-guided Microwave Ablation was performed using a GE LOGIQ E9 system with a C1-6 transducer, Nanjing Yigao ECO-100A1/ECO-100AL9 microwave device, and ECO-200F/100A6 disposable needles. Sonovue was used for CEUS. Single-needle multi-point ablation was performed for lesions \<3 cm, and double-needle ablation for lesions ≥3 cm, with needles ≤2 cm apart. Ablation power was 50-60 W, with a 3-6 min duration per point.Real-time ultrasound guided needle placement to avoid surrounding structures. After ablation, the needle was withdrawn, and the track sealed.Post-procedure, grayscale or CEUS confirmed the ablation coverage with a 5-10 mm safety margin. A follow-up CEUS was performed 1 day later to assess treatment efficacy. Systemic therapy was given for approximately 6 cycles. Patients received systemic therapy 2-4 weeks before or after ablation. Systemic therapy regimens included FOLFOX, XELOX, FOLFIRI, and FOLFOXIRI, with or without bevacizumab or cetuximab.

AS

liver resection combined with systemic therapy PROCEDURE

Laparoscopic Partial Liver Resection：Patients underwent laparoscopic partial liver resection, including exploration for extrahepatic metastases, resection of the liver lesion with surrounding tissue, and placement of a drainage tube. The procedure is performed under CO2 pneumoperitoneum with minimal invasive access via multiple ports. Systemic therapy was given for approximately 6 cycles. Patients received systemic therapy 2-4 weeks before or after liver resection. Systemic therapy regimens included FOLFOX, XELOX, FOLFIRI, and FOLFOXIRI, with or without bevacizumab or cetuximab.

RS

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective study included patients with colorectal liver metastases (≤5 lesions, ≤5 cm) who underwent thermal ablation with systemic therapy or liver resection with systemic therapy at four hospitals between January 2018 and April 2023.

You may qualify if:

• Age between 18 and 85 years.
• Primary tumor resected with R0 resection and pathological confirmation of colorectal adenocarcinoma.
• Liver metastasis confirmed by any two of the following examinations: contrast-enhanced CT, enhanced MRI, CEUS, PET-CT, or pathology.
• Liver metastases with maximum diameter ≤ 5 cm and ≤ 5 lesions.

You may not qualify if:

• History of other local treatments for liver metastasis prior to ultrasound-guided microwave ablation/liver resection.
• With concurrent extrahepatic metastases.
• With concurrent other malignancies.
• With incomplete clinical data.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130012, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: April 30, 2026
• Study Start: January 1, 2018
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: April 30, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)