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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034798
Receipt No. 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 2018/12/12

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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
Middle name
Last name Junya Matsumi
Organization National Cancer Center Hospital
Division name Department of Anesthesia and Intensive Care
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2166
Email jmatsumi@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junya Matsumi
Organization National Cancer Center Hospital
Division name Department of Anesthesia and Intensive Care
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan
TEL 03-3542-2166
Homepage URL
Email jmatsumi@ncc.go.jp

Sponsor
Institute National Cancer Center
Institute
Department

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
Address
Tel
Email

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 07 Day
Last modified on
2018 Year 12 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039598

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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