UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003324 |
|---|---|
| Receipt number | R000004038 |
| Scientific Title | Fibrin sealing with PGA felt for prevention of bleeding and bile leakage after liver resection |
| Date of disclosure of the study information | 2010/03/20 |
| Last modified on | 2016/02/10 11:32:08 |
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Basic information
Public title
Fibrin sealing with PGA felt for prevention of bleeding and bile leakage after liver resection
Acronym
Fibrin sealing with PGA felt for prevention of bleeding and bile leakage after liver resection
Scientific Title
Fibrin sealing with PGA felt for prevention of bleeding and bile leakage after liver resection
Scientific Title:Acronym
Fibrin sealing with PGA felt for prevention of bleeding and bile leakage after liver resection
Region
| Japan |
Condition
Condition
liver surgery
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the preventive effect for bleeding and biliary leakage, between fibrin sealing with PGA felt and collagen fleece on the liver cut surface.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Preventive effect for bleeding and biliary leakage
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Fibrin sealing with PGA felt
Interventions/Control_2
Collagen fleece
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
Liver surgery, written informed consent.
Key exclusion criteria
Allergy for the fibrin, PGA felt, collagen fleece.
Disability for communication with medical doctors.
Pregnancy
Others.
Target sample size
732
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Mori |
Organization
Osaka University
Division name
Surgery
Zip code
Address
Yamadaoka 2-2E2
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shogo Kobayashi |
Organization
Osaka University
Division name
Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Osaka University, Department of Surgery.
Institute
Department
Personal name
Funding Source
Organization
Osaka University
Organization
Division
Category of Funding Organization
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
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
| 2010 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
J Am Coll Surg. 2015 Oct 23. pii: S1072-7515(15)01673-7. doi: 10.1016/j.jamcollsurg.2015.10.006. [Epub ahead of print]
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
Main results already published
Date of protocol fixation
| 2009 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | 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
| 2010 | Year | 03 | Month | 12 | Day |
Last modified on
| 2016 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004038
