UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of diagnostic yield and post-ERCP pancreatitis in endoscopic pancreatic brush cytology
Title of the study (Brief title)	Transpapillary pancreatic brush cytology for pancreatic lesion
Region	Japan

Condition
Condition	pancreatic tumorous lesion with stricture
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate of diagnostic yield of brush cytology and factor for Post-ERCP pancreatitis (PEP)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Factor for Post-ERCP pancreatitis (PEP)
Key secondary outcomes	Accuracy of panreatic brush cytology

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Between August 2008 and August 2014 A total of 88 consecutive patients with suspected pancreatic tumorous lesions who underwent endoscopic pancretic brush cytology
Key exclusion criteria	No specific exclusion criteria
Target sample size	88

Research contact person
Name of lead principal investigator	Tesshin Ban
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Address	1 Kawasumi, Mizuho-ku, Nagoya
TEL	052-853-8211
Email	venzosan0204@gmail.com

Public contact
Name of contact person	Tesshin Ban
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Gastroenterology and Metabolism
Address	1 Kawasumi, Mizuho-ku, Nagoya
TEL	052-853-8211
Homepage URL
Email	venzosan0204@gmail.com

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization	No funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 28 Day
Anticipated trial start date	2015 Year 10 Month 26 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	Unpublished
URL releasing results
Results
Other related information	retrospective trial

Management information
Registered date	2015 Year 10 Month 25 Day
Last modified on	2018 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022537