UMIN-CTR Clinical Trial

Basic information
Public title	Confocal laser endoscopy for hepatobiliary pancreatic surgery
Acronym	Confocal laser endoscopy for hepatobiliary pancreatic surgery
Scientific Title	Confocal laser endoscopy for hepatobiliary pancreatic surgery
Scientific Title:Acronym	Confocal laser endoscopy for hepatobiliary pancreatic surgery
Region	Japan

Condition
Condition	neoplasm in heapato-biliary-panreatic system
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the usefulness of confocal lazer endomicroscopy for perioperative diagnosis in hepato-biliary-pancreatic surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison between diagnosis of confocal lazer endomicroscopy with the pathological findings
Key secondary outcomes	Comparison between findings of confocal lazer endomicroscopy with pathological findings

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Intravenous injection of fluorescein (300mg) and observe bile duct by confocal laser endomicroscopy
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	1)Patients who are undergoing HPB surgery 2)patients from whom informed consent was obtained
Key exclusion criteria	Patients who have allergy for fluorecein, in poor general condition, severe diabetes, severe heart disease, severe cerebral arterial disease, severe respiratory disease, severe hypertention, pregnancy, liver cirrhosis, or phenocromocytoma.
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kiyoshi Hasegawa
Organization	Tokyo university
Division name	Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL	0338155411
Email	kihase-tky@umin.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Masaru Matsumura
Organization	Tokyo university
Division name	Hepato-Biliary-Pancreatic Surgery Division
Zip code
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL	0338155411
Homepage URL
Email	MATSUMURAM-SUR@h.u-tokyo.ac.jp

Sponsor
Institute	University of Tokyo
Institute
Department

Funding Source
Organization	University of Tokyo
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
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

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 15 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	No longer recruiting
Date of protocol fixation	2017 Year 01 Month 06 Day
Date of IRB	2017 Year 01 Month 06 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2018 Year 05 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	2017 Year 08 Month 15 Day
Last modified on	2019 Year 05 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028465