UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003309 |
|---|---|
| Receipt number | R000004003 |
| Scientific Title | Prevention of bile leakage after hepatic resection by using indocyanine green fluorescent cholangiography. |
| Date of disclosure of the study information | 2010/03/09 |
| Last modified on | 2011/03/27 21:45:51 |
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Basic information
Public title
Prevention of bile leakage after hepatic resection by using indocyanine green fluorescent cholangiography.
Acronym
Prevention of bile leakage after hepatic resection by using indocyanine green fluorescent cholangiography.
Scientific Title
Prevention of bile leakage after hepatic resection by using indocyanine green fluorescent cholangiography.
Scientific Title:Acronym
Prevention of bile leakage after hepatic resection by using indocyanine green fluorescent cholangiography.
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma, intrahepatic cholangiocellular carcinoma, metastatic liver tumors
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Bile leakage remains a problem after hepatic surgery and there are no standard preventive methods. The aim of the present randomized clinical trial is to evaluate the usefulness of indocyanine green (ICG) cholangiography for preventing postoperative bile leakage.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of postoperative bile leakage
Key secondary outcomes
Incidence of postoperative complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
The conventional test of indocyanine green (ICG) cholangiography for preventing postoperative bile leakage is as control group.
Interventions/Control_2
Fluorescent imaging with a Photodynamic Eye imaging system.
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 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients that agree this study on document of informed concent
The inclusion criteria is elective hepatectomy, no bilioenterostomy,
Key exclusion criteria
Patients with allergy for indocyanine green
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Kaibori |
Organization
Kansai Medical University
Division name
Surgery
Zip code
Address
2-3-1 Shinmachi, Hirakata, Osaka 573-1191, Japan
TEL
+81-72-804-0101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Kaibori |
Organization
Kansai Medical University
Division name
Surgery
Zip code
Address
2-3-1 Shinmachi, Hirakata, Osaka 573-1191, Japan
TEL
+81-72-804-0101
Homepage URL
kaibori@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University
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
関西医科大学附属枚方病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 03 | Month | 09 | 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
| 2008 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 03 | Month | 09 | Day |
Last modified on
| 2011 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004003
