Microwave Ablation for Pulmonary Metastases From Colorectal Cancer

August 11, 2016 updated by: The First People's Hospital of Changzhou

CT-guided Percutaneous Microwave Ablation for Pulmonary Metastases From Colorectal Cancer

(MWA) is the most recent development in the field of local ablative therapies. The aim of this study was to evaluate CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

From June 2010 to June 2015, 48 unresectable lesions in 32 patients with pulmonary metastases from colorectal cancer were selected for CT-guided microwave ablation. Patients were scheduled for a 1 and 3 month CT follow-up to evaluate lesion diameter.We retrospectively evaluated CT-guided percutaneous microwave (MW) ablation safety and efficacy in pulmonary metastases from colorectal cancer.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Unresectable pulmonary metastases from colorectal cancer.
  • diagnosis by CT, and confirmed by percutaneous puncture biopsy.
  • Age range 18-70 years old.
  • Eastern Cooperative Oncology Group performance status 0-1.
  • Life expectancy of more than 3 months.
  • Adequate organ function.

Exclusion Criteria:

  • Resectable lung metastases.
  • Life expectancy less than 3 months
  • Patients with cardiac pacemaker, cerebral aneurysm clips, implanted electronic instruments or other metal materials.
  • Coagulopathy with platelet count less than 50000.
  • Active infectious disease.
  • Age below 18 years.
  • Pregnancy of breastfeeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treated with microwave ablation
Patients undergoing MWA for pulmonary metastases from colorectal cancer.
Device: microwave ablation
pulmonary metastases from colorectal cancer are destructed/ablated using microwave ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment related adverse events
Time Frame: Eight weeks
Eight weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First People's Hospital of Changzhou

Investigators

  • Study Director: Jingting Jiang, PD, The First People's Hospital of Changzhou

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

July 15, 2015

First Submitted That Met QC Criteria

July 16, 2015

First Posted (Estimate)

July 20, 2015

Study Record Updates

Last Update Posted (Estimate)

August 15, 2016

Last Update Submitted That Met QC Criteria

August 11, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC-MW-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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