UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of a newly designed biliary cytology brush for malignant biliary stricture
Title of the study (Brief title)	New biliary device study
Region	Japan

Condition
Condition	Malignant biliary strictures
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To elucidate that diagnostic ratio of malignant biliary stricture is improved by using the newly designed cytology brush after biopsy forceps.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Difference of sensitivity and specificity between the newly designed cytology brush after using biopsy forceps and biopsy forceps alone.
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	Device,equipment
Interventions/Control_1	The new device is used after a biopsy forceps during ERCP in cases of malignant biliary stricture.
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. Malignant biliary stricture is suspected. 2. The patient in whom ERCP can be done by a side-viewing endscope via ampulla of Vater . 3. The patients in whom written infomed consent is obtained.
Key exclusion criteria	1. Performance status 4. 2. ASA physical status is more than 3. 3. Judged as inadequate for this study by the investigator.
Target sample size	140

Research contact person
Name of lead principal investigator	Shujiro Yazumi
Organization	The Tazuke Kofukai medical research institute Kitano Hospital
Division name	Division of gastroenterology and hepatology Digestive disease center
Address	2-4-20 Ohgimachi, Kita-ku, Osaka, JAPAN
TEL	06-6312-1221
Email	s-yazumi@kitano-hp.or.jp

Public contact
Name of contact person	Yojiro Sakuma
Organization	Kyoto University
Division name	Faculty of medicine
Address	Yoshidakonoe-cho, Sakyo-ku, Kyoto, JAPAN
TEL	075-751-4319
Homepage URL
Email	yojiro@kuhp.kyoto-u.ac.jp

Sponsor
Institute	The Tazuke Kofukai medical research institute Kitano Hospital
Institute
Department

Funding Source
Organization	The Tazuke Kofukai medical research institute Kitano Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Gastroenterology and Hepatology, Graduate school of medicine, Kyoto University
Name of secondary funｄer(s)

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	Kyoto university hospital (Kyoto), Kitano hospital (Osaka) and Kyoto university related hospitals (Shizuoka, Shiga, Nara, Kyoto, Osaka, Wakayama, Hyogo)

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 01 Month 15 Day
Anticipated trial start date	2013 Year 03 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 01 Month 29 Day
Last modified on	2016 Year 09 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011478