Independent Risk Factors Analysis and Model Construction For Recurrence After Radiofrequency/Microwave Ablation of Colorectal Cancer With Liver Metastases: a Retrospective, Multicenter Trial

• Conditions: Colorectal Cancer With Liver Metastases

• Registration Number: NCT05268549
• Lead Sponsor: The Central Hospital of Lishui City

Brief Summary

This study is a retrospective, multicenter clinical study. The main objective is to analyze the risk factors affecting the recurrence of colorectal cancer patients with liver metastases who received radiofrequency/microwave ablation. Finally, we will construct a recurrence risk prediction model based on the risk factors and validated the model.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-10
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-03
• Last Update Submitted: 2022-03-03
• Study First Posted: 2022-03-07
• Last Update Posted: 2022-03-07
• Study Start: 2022-03-12
• Primary Completion: 2022-05-12
• Study Completion: 2022-08-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Age：older than 18 years；
2. Patients with a single tumor diameter ≤5cm, no more than 3 tumor nodules, and the largest tumor diameter ≤3cm；
3. Absence of vessel, bile duct and adjacent organ invasion and distant metastasis;
4. The primary tumor of colorectal cancer has been resected, the liver metastases cannot be resected or the patient is unwilling to undergo surgery (clinical or pathological confirmation);
5. Normal coagulation status and liver function child-pugh A or B;
6. Liver metastases have not received other antitumor therapy after radiofrequency/microwave therapy (before disease progression);
7. Routine laboratory tests were performed before the first RF/microwave treatment;
8. Follow up for more than 12 months;
9. Obtained free informed consent.

Exclusion Criteria

1. Large tumor, or diffuse intrahepatic metastasis;
2. Accompanied by vascular tumor thrombus or invasion of adjacent organs;
3. The primary tumor of colorectal cancer has not been resected, with extrahepatic metastasis;
4. Uncorrectable coagulation dysfunction and severe blood abnormalities, those with severe bleeding tendency;
5. Intractable massive ascites, cachexia;
6. Active infection, especially inflammation of the biliary system;
7. Severe liver, kidney, heart, lung, brain and other major organ failure;
8. Patients with impaired consciousness or unable to cooperate with treatment;
9. Missing follow-up data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The first recurrence of colorectal cancer with liver metastasis (CRLM) after radiofrequency/microwave ablation, assessed up to 18 months	Time from enrollment to disease recurrence, assessed up to 18 months	The first recurrence of colorectal cancer with liver metastasis (CRLM) after radiofrequency/microwave ablation, assessed up to 18 months

Secondary Outcome Measures

Name	Time	Method
Patients with colorectal cancer with liver metastases (CRLM) developed new metastases after radiofrequency/microwave ablation,assessed up to 18 months	Time from enrollment to developed new metastases, assessed up to 18 months	Patients with colorectal cancer with liver metastases (CRLM) developed new metastases after radiofrequency/microwave ablation,assessed up to 18 months