the Influence of General Anesthesia on Tumor Metastasis and Recurrence
Sponsor
RenJi Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02474511
Collaborator
(none)
300
1
46
6.5
Study Details
Study Description
Brief Summary
The purpose of this study was to investigate whether general anesthesia will affect the postoperative recurrence and metastasis of malignant tumor.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Study Start Date
:
Jun 1, 2015
Anticipated Primary Completion Date
:
Jun 1, 2018
Anticipated Study Completion Date
:
Apr 1, 2019
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Number of participants with tumor recurrence and metastasis [3 years]
Follow-up of patients with tumor recurrence and metastasis after Radiofrequency ablation to 3 years
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Renji Hospital | Shanghai | Shanghai | China | 200127 |
Sponsors and Collaborators
- RenJi Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
RenJi Hospital
ClinicalTrials.gov Identifier:
NCT02474511
Other Study ID Numbers:
- 仁济伦审[2015]058K
First Posted:
Jun 17, 2015
Last Update Posted:
Jun 17, 2015
Last Verified:
Jun 1, 2015