UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003414 |
|---|---|
| Receipt number | R000003656 |
| Scientific Title | Efficacy of Seprafilm for prevention of postoperative adhesions after liver surgery: clinical study |
| Date of disclosure of the study information | 2010/03/31 |
| Last modified on | 2015/10/22 15:20:43 |
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Basic information
Public title
Efficacy of Seprafilm for prevention of postoperative adhesions after liver surgery: clinical study
Acronym
Prevention of adhesions by Seprafilm after liver surgery
Scientific Title
Efficacy of Seprafilm for prevention of postoperative adhesions after liver surgery: clinical study
Scientific Title:Acronym
Prevention of adhesions by Seprafilm after liver surgery
Region
| Japan |
Condition
Condition
hepatocellular carcinoma and metastatic cancer of the liver
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of Seprafilm for the prevention of the postoperative adhesions in liver surgery
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
adhesion scores, time and amount of the blood loss needed for dissecting the adhesions in reoperation of the liver in future
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
application of Seprafilm after hepatectomy for the treatment of hepatocellular carcinoma or metastatic liver tumors
Interventions/Control_2
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
Cases of hepatectomy scheduled for the treatment of hepatocellular carcinoma or metastatic liver tumors in our department.
Key exclusion criteria
If the patient has peritonitis or infectious complications,
If the patient has the history of severe allergy,
If dissection of lymph node or other is requred, or
If the patients do not agree,
the patients will be excluded from this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Kokudo |
Organization
Graduate School of Medicine, University of University of Tokyo
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
kihase-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihiro Kokudo |
Organization
Graduate School of Medicine, University of University of Tokyo
Division name
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
kihase-tky@umin.ac.jp
Sponsor or person
Institute
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery,Graduate School of Medicine, University of University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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 | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2009 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 31 | Day |
Last modified on
| 2015 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003656
