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

NCT ID: NCT05268549

Last Updated: 2022-03-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-12
• Study Completion Date: 2022-08-12

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.

Conditions

Colorectal Cancer With Liver Metastases

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: collaborator

Zhejiang University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

The Central Hospital of Lishui City

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Zhongwei Zhao, Dr

Role: CONTACT

zhaozw79@163.com

15925728781

Dengke Zhang, Dr

Role: CONTACT

dk198646@163.com

15957823142

Other Identifiers

ZJLS-KLDMIR-22005

Identifier Type: -

Identifier Source: org_study_id