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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000017608
Receipt No. R000020410
Scientific Title The safety of liver surgery with No-Drain policy: a multicenter randomized controlled trial
Date of disclosure of the study information 2015/05/18
Last modified on 2017/11/19

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Basic information
Public title The safety of liver surgery with No-Drain policy: a multicenter randomized controlled trial
Acronym No drain policy in liver surgery
Scientific Title The safety of liver surgery with No-Drain policy: a multicenter randomized controlled trial
Scientific Title:Acronym No drain policy in liver surgery
Region
Japan

Condition
Condition Elective hepatic resection without biliary reconstruction
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety after hepatic resection using Clavien-Dindo grading system comparing with and without drain
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Frequency of postoperative complication at or greater than Clavien-Dindo grade 3
Key secondary outcomes Wound-related complication, total postoperative complication, biliary leakage, inflammatory indicator in blood and serum examination, duration of postoperative hospital stay

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Placement of abdominal drain
Interventions/Control_2 Absent of abdominal drain
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Undergoing elective hepatic resection without biliary reconstruction
2) ECOG performance status: 0-2
3) Unimpaired organ function:
1. WBC >= 2,000/mm3
2. Plt >= 50,000/mm3
3. T.Bil <= 2.0 mg/dL
4. Cre <= 1.5 mg/dL
4) Age: 20 years or older
5) Written informed consent
Key exclusion criteria 1) Concomitant resection of other organs excluding gallbladder
2) Administration of anti-coagulant drug just before the operation
3) Schedule to administrate anti-coagulant drug by 3 days after operation
4) Psychiatric disorder
5) Pregnant
6) Supposed extremely high risk of biliary leakage or bleeding after operation because of area of hepatic transection, and exposure of Glisson sheath on transection surface
7) C-tube placement
8) Thoracic tube placement
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Arita
Organization Graduate School of Medicine, University of Tokyo
Division name Hepatobiliary-Pancreatic Surgery Division, Department of Surgery
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, 135-8655
TEL +81-3-3815-5411
Email jarita-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Arita
Organization Graduate School of Medicine, University of Tokyo
Division name Hepatobiliary-Pancreatic Surgery Division, Department of Surgery
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, 135-8655
TEL +81-3-3815-5411
Homepage URL
Email jarita-tky@umin.ac.jp

Sponsor
Institute Hepatobiliary-Pancreatic Surgery Division, Graduate School of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Non profit foundation
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 YES
Study ID_1 P2015004-11Y
Org. issuing International ID_1 Research Ethics Committee, Graduate School of Medicine, University of Tokyo
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 18 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 Completed
Date of protocol fixation
2015 Year 04 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 05 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 18 Day
Last modified on
2017 Year 11 Month 19 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020410

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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