UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006259 |
|---|---|
| Receipt number | R000007407 |
| Scientific Title | Efficacy of contrast-enhanced intraoperative ultrasonic cholangiography using sonazoid in hepatobiliary disease |
| Date of disclosure of the study information | 2011/10/01 |
| Last modified on | 2019/05/20 10:31:52 |
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Basic information
Public title
Efficacy of contrast-enhanced intraoperative ultrasonic cholangiography using sonazoid in hepatobiliary disease
Acronym
intraoperative ultrasonic cholangiography using sonazoid
Scientific Title
Efficacy of contrast-enhanced intraoperative ultrasonic cholangiography using sonazoid in hepatobiliary disease
Scientific Title:Acronym
intraoperative ultrasonic cholangiography using sonazoid
Region
| Japan |
Condition
Condition
hepatobiliary disease or donor in living donor liver transplantation
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of inraoperaive ultrasonography with cholangiography using sonazoid.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the ability to visualize a biliary road map intraoperatively
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
intraoperative ultrasonic cholangiography using sonazoid
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patient who undergo hepatectomy with cholecystectomy
2)Patient who underwent abdominal enhanced ultrasonography using sonazoid intravenously and didn't have any allergy
3)Patient who write informed consent
Key exclusion criteria
1)Allergy for sonazoid
2)Allergy for egg and dairy product
3)Patient who have cholecystitis or cholangitis
4)Patients seems inadequate for this study by investigaors
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Fukumoto |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
Zip code
650-0017
Address
7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe-City, Hyogo
TEL
0783826302
fukumoto@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Urade |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
Zip code
650-0017
Address
7-5-1 Kusunoki-Cho, Chuo-Ku, Kobe-City, Hyogo
TEL
0783826302
Homepage URL
junsuzu@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine
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
Kobe University Hospital Clinical & Translational Research Center
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN, 650-0017
Tel
078-382-6669
chiken@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
神戸大学医学部附属病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000007407
Publication of results
Published
Result
URL related to results and publications
https://www.journalacs.org/article/S1072-7515(13)01146-0/fulltext
Number of participants that the trial has enrolled
46
Results
Bibliography:
Contrast-enhanced intraoperative ultrasonic cholangiography for real-time biliary navigation in hepatobiliary surgery.J Am Coll Surg. 2014 Feb;218(2):e43-50.
Contrast-enhanced intraoperative ultrasonic cholangiography in living donor hepatectomy.Liver Transpl. 2016 Oct;22(10):1437-42.
(https://aasldpubs.onlinelibrary.wiley.com/doi/epdf/10.1002/lt.24519)
Results date posted
| 2019 | Year | 05 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who are scheduled to undergo hepatobiliary surgery against hepatobiliary diseases or donors who are scheduled to undergo living donor hepatectomy for living donor liver transplantation
Participant flow
The participants undergo the operation and have perioperative management in Kobe university hospital.
Adverse events
none
Outcome measures
Detectability of bile ducts with contrast-enhanced intraoperative ultrasonic cholangiography
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 08 | Month | 31 | Day |
Last modified on
| 2019 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007407
