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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003309
Receipt No. 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

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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
Email

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
Email kaibori@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004003

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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