UMIN-CTR Clinical Trial

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
Email	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
Email	uradet1125@gmail.com

Sponsor
Institute	Kobe University hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035423