the Influence of General Anesthesia on Tumor Metastasis and Recurrence

June 16, 2015 updated by: RenJi Hospital
The purpose of this study was to investigate whether general anesthesia will affect the postoperative recurrence and metastasis of malignant tumor.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Shanghai Renji Hospital
        • Contact:

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

the patient with primary liver cancer.

Description

Inclusion Criteria:

  • ASA I - III Primary liver cancer tumor is single and diameter is less than 3 centimeter There is no major vascular invasion phenomenon, no lymph nodes or extrahepatic metastases The Child - Pugh belong to type A or type B

Exclusion Criteria:

  • Had a history of liver surgery (including radiofrequency ablation) Severe disease of heart, lung, kidney, the immune system INR > 1.5 or platelet count is less than 45000 cells/mm3 History of opioid addiction Metastatic liver tumors Not sure of primary liver cancer Don't agree to participate in this experiment

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
general anesthesia
In this group，the patient is received radiofrequency ablation under general anesthesia.
Other: general anesthesia and local anesthesia
the patient received generalanesthesia and local anesthesia randomly
local anesthesia
In this group，the patient is received radiofrequency ablation under local anesthesia.
Other: general anesthesia and local anesthesia
the patient received generalanesthesia and local anesthesia randomly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with tumor recurrence and metastasis
Time Frame: 3 years
Follow-up of patients with tumor recurrence and metastasis after Radiofrequency ablation to 3 years
3 years

Collaborators and Investigators

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

Sponsor

RenJi Hospital

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, 2015

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

April 1, 2019

Study Registration Dates

First Submitted

June 14, 2015

First Submitted That Met QC Criteria

June 16, 2015

First Posted (Estimate)

June 17, 2015

Study Record Updates

Last Update Posted (Estimate)

June 17, 2015

Last Update Submitted That Met QC Criteria

June 16, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 仁济伦审[2015]058K

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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