UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031236 |
|---|---|
| Receipt number | R000035423 |
| Scientific Title | A clinical study on the efficacy of leakage test performed with intraoperative ultrasonic cholangiography in hepatic resection |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2020/09/01 17:41:14 |
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Basic information
Public title
A clinical study on the efficacy of leakage test performed with intraoperative ultrasonic cholangiography in hepatic resection
Acronym
The efficacy of leakage test performed with intraoperative ultrasonic cholangiography in hepatic resection
Scientific Title
A clinical study on the efficacy of leakage test performed with intraoperative ultrasonic cholangiography in hepatic resection
Scientific Title:Acronym
The efficacy of leakage test performed with intraoperative ultrasonic cholangiography in hepatic resection
Region
| Japan |
Condition
Condition
liver tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the usefulness and safety of leakage test after hepatic resection performed with contrast-enhanced intraoperative ultrasonic cholangiography.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success of intraoperative leakage test after hepatic resection
Key secondary outcomes
Postoperative bile leakage
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
At the timing of leakage test after hepatic resection, diluted Sonazoid is co-injected with indigo carmine to perform contrast-enhanced intraoperative ultrasonic cholangiography.
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
Patients who undergo hepatic resection without biliary reconstruction.
Patients who need cholecystectomy for hepatic resection.
Patients who have no side effects by venous injection of sonazoid at preoperative abdominal ultrasonography.
Key exclusion criteria
Patients who are hypersensitive to sonazoid.
Patients who are allergic to egg or products made by egg.
Patients who have preoperative cholecystitis or cholangitis.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Fukumoto |
Organization
Kobe University hospital
Division name
Hepato-Biliary-Pancreatic Surgery
Zip code
6500017
Address
7-5-2, Kusunokicho, Chuo-Ku, Kobe city, Japan
TEL
078-382-6302
fukumoto@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Urade |
Organization
Kobe University hospital
Division name
Hepato-Biliary-Pancreatic Surgery
Zip code
6500017
Address
7-5-2, Kusunokicho, Chuo-Ku, Kobe city, Japan
TEL
078-382-6302
Homepage URL
uradet1125@gmail.com
Sponsor or person
Institute
Kobe University hospital
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University hospital
Address
7-5-2, Kusunokicho, Chuo-Ku, Kobe city, Japan
Tel
0783826302
hbp1kobe@med.kobe-u.ac.jp
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
| 2018 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 09 | Day |
Last modified on
| 2020 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035423
