UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012929 |
|---|---|
| Receipt number | R000015122 |
| Scientific Title | Observation and Prevention of Adhesions in patients with Repeated Hepatectomy |
| Date of disclosure of the study information | 2014/01/24 |
| Last modified on | 2014/07/14 11:00:39 |
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Basic information
Public title
Observation and Prevention of Adhesions in patients with Repeated Hepatectomy
Acronym
Adhesions in patients with Repeated Hepatectomy
Scientific Title
Observation and Prevention of Adhesions in patients with Repeated Hepatectomy
Scientific Title:Acronym
Adhesions in patients with Repeated Hepatectomy
Region
| Japan |
Condition
Condition
Diseases previously treated with hepatectomy and targeted for repeated hepatectomy(hepatic cancer)
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To directly observe adhesions in repeated hepatectomy, and clarify their extent and severity, as well as the influences of anti-adhesion materials on the duration of surgery.
Basic objectives2
Others
Basic objectives -Others
To directly observe adhesions in repeated hepatectomy, and clarify their extent and severity, as well as the influences of anti-adhesion materials on the duration of surgery.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Extent and severity of postoperative adhesions
Key secondary outcomes
Duration of surgery and bleeding output
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are scheduled for repeated hepatectomy, and met for all the following criteria:
1) Those aged 18 and over, who have a history of hepatectomy, and are targeted for repeated hepatectomy.
2) Those in whom the use/non-use of Seprafilm in previous hepatectomy can be confirmed.
3) Those whose systemic conditions allow them to undergo surgery under general anesthesia (ECOG PS 0-1).
4) Those whose liver function allows them to undergo hepatectomy.
5) Those whose written consent has been obtained.
Key exclusion criteria
1) Those repuiring emergent surgery.
2) Those specified in contraindications in the package insert for the study drug, or with a history of severe hypersensitivity.
3) Pregnant or lactating females or those who are likely to be pregnant.
4) Those who have been considered inappropriate for this study for other reasons by investigators.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Uemoto Shinji |
Organization
Kyoto University Hospital
Division name
Hepatobiliary Pancreatic Surgery and Transplantation
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku,Kyoto-shi,Kyoto
TEL
075-751-3242
uemoto@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nakamura Naohiko |
Organization
Kyoto University Hospital
Division name
Hepatobiliary Pancreatic Surgery and Transplantation
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku,Kyoto-shi,Kyoto
TEL
075-751-3242
Homepage URL
n1982422@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
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
| 2014 | Year | 01 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2014 | Year | 01 | Month | 23 | Day |
Last modified on
| 2014 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015122
