UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034798 |
|---|---|
| Receipt number | R000039598 |
| Scientific Title | Difference between anesthetic agents on liver damages after liver resection |
| Date of disclosure of the study information | 2018/12/12 |
| Last modified on | 2022/11/14 12:57:54 |
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Basic information
Public title
Difference between anesthetic agents on liver damages after liver resection
Acronym
Difference between anesthetic agents on liver damages after liver resection
Scientific Title
Difference between anesthetic agents on liver damages after liver resection
Scientific Title:Acronym
Difference between anesthetic agents on liver damages after liver resection
Region
| Japan |
Condition
Condition
metastatic liver tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify the difference between anesthetic agents on liver damages after liver resection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
max value of the aspartate aminotransferase during postoperative 3 days
Key secondary outcomes
max value of the alanine transaminase and total bilirubin during postoperative 3 days and postoperative complication defined by JCOG postoperative complication criteria according to Clavien-Dindo Classification grade 2 or more.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
sevoflurane arm permits only use of sevoflurane for maintenance of anesthesia.
Interventions/Control_2
propoforl arm permits only use of propofol for maintenance of anesthesia.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. elective resection for metastatic liver tumor( including suspect of metastatic tumor) from any primary tumor, and estimated number of these tumors is 5 or under, and resection size is under Couinaud 5 area.
2. preoperative values of aspartate aminotransferase and alanine aminotransferase are both under 100 IU/L.
3. NOT scheduling primary tumor resection and/of radiofrequency ablation at the same time as liver resection.
4.NOT scheduling biliary reconstruction at the same time as liver resection.
5. obtained written infromed consent from patient.
Key exclusion criteria
1. known allergy of study drugs
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Junya |
| Middle name | |
| Last name | Matsumi |
Organization
National Cancer Center Hospital
Division name
Department of Anesthesia and Intensive Care
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2166
jmatsumi@ncc.go.jp
Public contact
Name of contact person
| 1st name | Junya |
| Middle name | |
| Last name | Matsumi |
Organization
National Cancer Center Hospital
Division name
Department of Anesthesia and Intensive Care
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2166
Homepage URL
jmatsumi@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
ncch-irb@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
https://jsa-shoroku.jp/search/detail_program/id:4121
Publication of results
Published
Result
URL related to results and publications
https://jsa-shoroku.jp/search/detail_program/id:4121
Number of participants that the trial has enrolled
58
Results
The primary and key secondary endpoints, peak AST and peak ALT three days after surgery, were significantly higher in the sevoflurane group than in the propofol group.
Although there was significantly different in the operation time between groups, there was no significant difference in the ischemic time may affect postoperative AST and ALT. Therefore, the effect of the difference of operation time on outcomes is considered to be limited. In conclusion, a hepatoprotective effect of propofol is suggested.
Results date posted
| 2022 | Year | 11 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There was no significant difference in background between the two groups, except for a significantly longer operation time in the sevoflurane group.
Participant flow
During the period, 117 patients became candidates, as 53 patients were excluded for non-meeting the inclusion criteria, and 8 patients were excluded due to rejection to participate in the study, 56 patients were divided into two groups.
Two patients in the sevoflurane group and 1 patients in the propofol group had protocol deviations for clinically valid reasons, so the per-protocol analysis included 26 patients in the sevoflurane group and 27 patients in the propofol group.
Adverse events
No adverse events were considered study-related.
Outcome measures
The primary and key secondary endpoints, peak AST and peak ALT three days after surgery, were significantly higher in the sevoflurane group than in the propofol group.
There were no significant differences in the secondary endpoints, the highest total bilirubin level for 3 days after surgery and postoperative complications.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 07 | Day |
Last modified on
| 2022 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039598
