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Status unknownNCT05268549Updated Mar 7, 2022

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

An observational study in Colorectal Cancer With Liver Metastases, sponsored by The Central Hospital of Lishui City. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-07.

Sponsored by The Central Hospital of Lishui City · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colorectal Cancer With Liver Metastases

Keywords

  • colorectal cancer with liver metastases
  • Radiofrequency/Microwave
  • Recurrence
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 80 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

The Central Hospital of Lishui City is the lead sponsor of 8 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
80 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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 frame: Time from enrollment to disease recurrence, assessed up to 18 months

Secondary outcomes

  1. 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 frame: Time from enrollment to developed new metastases, assessed up to 18 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — Statistical analysis plan, informed consent form, and clinical study report can be shared with other researchers.

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05268549
Lead sponsor
The Central Hospital of Lishui City
Collaborators
Zhejiang Cancer Hospital, Zhejiang University, First Affiliated Hospital of Wenzhou Medical University
Responsible party
Sponsor
First posted
Mar 7, 2022
Start date
Mar 12, 2022 (estimated)
Primary completion
May 12, 2022 (estimated)
Completion
Aug 12, 2022 (estimated)
Last update
Mar 7, 2022

Study contacts

Zhongwei Zhao, Dr
Contact
zhaozw79@163.com
15925728781
Dengke Zhang, Dr
Contact
dk198646@163.com
15957823142

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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