UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017608 |
|---|---|
| Receipt number | 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 13:04:26 |
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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
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
jarita-tky@umin.ac.jp
Sponsor or person
Institute
Hepatobiliary-Pancreatic Surgery Division, Graduate School of Medicine, University of Tokyo
Institute
Department
Personal name
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
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
Value
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 | |
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| Registered date | File name |
| Research case data | |
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