UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A transpapillary guidewire-assisted bile duct biopsy technique for advancing through the papilla of Vater or biliary obstruction in difficult cases of pancreatico-biliary disease
Title of the study (Brief title)	Guidewire-assisted technique for bile duct
Region	Japan

Condition
Condition	Pancreatico-biliary disease
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the feasibility, safety, and clinical outcome of transpapillary guidewire-assisted bile duct biopsy using a jaw configuration biopsy forceps for pancreatico-biliary disease
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Inducibility of a guidewire-assisted biopsy technique (into the bile duct or advance throught the biliary obstruction)
Key secondary outcomes	Safety and diagnostic ability of a guidewire-assisted biopsy technique

Base
Study type

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Jaw configuration biopsy forceps
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	Cases failed to advance through the papilla of Vater or biliary obstruction by a conventional biopsy forceps within 5 minutes after a guidewire placement.
Key exclusion criteria	i) Impossible cases of ERCP ii) Cases of difficult selective bile duct cannulation
Target sample size	10

Research contact person
Name of lead principal investigator	Hiroshi Kawakami
Organization	Hokkaido University Hospital
Division name	Department of Gastroenterology
Address	Kita 14, Nishi 5, Kita-ku, Sapporo
TEL	+81-11-716-1161
Email	hiropon@med.hokudai.ac.jp

Public contact
Name of contact person	Hiroshi Kawakami
Organization	Hokkaido University Hospital
Division name	Department of Gastroenterology and Hepatology
Address	Kita 14, Nishi 5, Kita-ku, Sapporo
TEL	+81-11-716-1161
Homepage URL
Email	hiropon@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Department of Gastroenterology and Hepatology, Hokkaido University Hospital
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	北海道大学病院（北海道）

Other administrative information
Date of disclosure of the study information	2015 Year 01 Month 26 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 01 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

Management information
Registered date	2015 Year 01 Month 25 Day
Last modified on	2017 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018949