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

Colorectal Cancer With Liver Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05268549
• Other study ID #: ZJLS-KLDMIR-22005
• Status: Not yet recruiting
• Start date: March 12, 2022
• Est. completion date: August 12, 2022

Study information

• Verified date: March 2022
• Source: The Central Hospital of Lishui City
• Contact: Zhongwei Zhao, Dr
• Phone: 15925728781
• Email: zhaozw79[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 12, 2022
• Est. primary completion date: May 12, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer With Liver Metastases
• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Recurrence

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
The Central Hospital of Lishui City	First Affiliated Hospital of Wenzhou Medical University, Zhejiang Cancer Hospital, Zhejiang University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The first recurrence of colorectal cancer with liver metastasis (CRLM) after radiofrequency/microwave ablation, assessed up to 18 months	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
Secondary	Patients with colorectal cancer with liver metastases (CRLM) developed new metastases after radiofrequency/microwave ablation,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	Time from enrollment to developed new metastases, assessed up to 18 months