NCT02474511

Brief Summary

The purpose of this study was to investigate whether general anesthesia will affect the postoperative recurrence and metastasis of malignant tumor.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

June 17, 2015

Status Verified

June 1, 2015

Enrollment Period

3 years

First QC Date

June 14, 2015

Last Update Submit

June 16, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants with tumor recurrence and metastasis

    Follow-up of patients with tumor recurrence and metastasis after Radiofrequency ablation to 3 years

    3 years

Study Arms (2)

general anesthesia

In this group,the patient is received radiofrequency ablation under general anesthesia.

Other: general anesthesia and local anesthesia

local anesthesia

In this group,the patient is received radiofrequency ablation under local anesthesia.

Other: general anesthesia and local anesthesia

Interventions

the patient received generalanesthesia and local anesthesia randomly

general anesthesialocal anesthesia

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

the patient with primary liver cancer.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Renji Hospital

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

RecurrenceNeoplasm Metastasis

Interventions

Anesthesia, GeneralAnesthesia, Local

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplastic ProcessesNeoplasms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaAnesthesia, Conduction

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2015

First Posted

June 17, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2018

Study Completion

April 1, 2019

Last Updated

June 17, 2015

Record last verified: 2015-06

Locations