Clinical trial NCT05268549: Independent Risk Factors Analysis and Model Construction For Recurrence After Radiofrequency/Microwave Ablation of Colorectal Cancer With Liver Metastases: a Retrospective, Multicenter 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer With Liver Metastases
Keywords: colorectal cancer with liver metastases
Radiofrequency/Microwave
Recurrence
Lead sponsor: The Central Hospital of Lishui City
Sponsor class: OTHER
Collaborators: name: Zhejiang Cancer Hospital
name: Zhejiang University
name: First Affiliated Hospital of Wenzhou Medical University
First posted: 2022-03-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a multicenter study. Patients from Lishui Central Hospital of Zhejiang Province, Zhejiang Cancer Hospital, the First Affiliated Hospital of Zhejiang University, the Second Affiliated Hospital of Zhejiang University, and the First Affiliated Hospital of Wenzhou Medical University who meet the above criteria will be included in this study

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.


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.

Primary outcomes:
measure: The first recurrence of colorectal cancer with liver metastasis (CRLM) after radiofrequency/microwave ablation, assessed up to 18 months
timeFrame: Time from enrollment to disease recurrence, assessed up to 18 months
Secondary outcomes:
measure: Patients with colorectal cancer with liver metastases (CRLM) developed new metastases after radiofrequency/microwave ablation,assessed up to 18 months
timeFrame: Time from enrollment to developed new metastases, assessed up to 18 months
Other outcomes:
Locations:
Study officials:
References: