UMIN-CTR Clinical Trial

Basic information
Public title	pCLE for pancreato-biliary diseases
Acronym	pCLE for pancreato-biliary diseases
Scientific Title	pCLE for pancreato-biliary diseases
Scientific Title:Acronym	pCLE for pancreato-biliary diseases
Region	Japan

Condition
Condition	pancreato-biliary diseases
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	primary endpoint, safety
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	safety 24hours after procedure symptom P.S. Blood,RBC,Hb,Hct,WBC,Plt Tbil,Alp,AST(GOT),ALT(GOT),GTP,LDH,BUN,Cre,AMY,P-AMY,Na,K,Cl,CRP
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
Interventions/Control_1	Endoscopic diagnosis using pCLE
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	100 years-old >
Gender	Male and Female
Key inclusion criteria	1. no main organ failure 2. PS 0-2 3. IC by the patient
Key exclusion criteria	1. easy bleeding 2. doctor 's opinion
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazuo Hara
Organization	Aichi Cancer Center Hospital
Division name	Gastroenterology
Zip code
Address	1-1 Kanokoden Tikusa-ku
TEL	052-762-6111
Email	khara@aichi-cc.jp

Public contact
Name of contact person	1st name Middle name Last name Kazuo Hara
Organization	ACC
Division name	Gastroenterology
Zip code
Address	1-1Kanokoden Tikusa-ku Nagoya
TEL	052-762-6111
Homepage URL
Email	khara@aichi-cc.jp

Sponsor
Institute	ACC(Aichi Cancer Center Hospital)
Institute
Department

Funding Source
Organization	ACC(Aichi Cancer Center Hospital)
Organization
Division
Category of Funding Organization	Local Government
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	2015 Year 08 Month 21 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	2015 Year 01 Month 01 Day
Date of IRB	2014 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 01 Month 10 Day
Last follow-up date	2021 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 08 Month 21 Day
Last modified on	2021 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021703