UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of physician-controlled wire-guided cannulation for bile duct using a novel shincterotome.
Title of the study (Brief title)	Efficacy of physician-controlled wire-guided cannulation using a novel shincterotome.
Region	Japan

Condition
Condition	common bile duct stones, obstructive jaundice, acute cholangitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and the safety of wire-guided cannulation for bile duct using a novel sphincterotome
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Proportion of bile duct cannulation success within 10 minutes
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	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Bile duct cannulation will be attempted by wire-guided cannulation using a novel sphincterotome
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	Patients are eligible for this Study if they meet all the criteria shown below. Patients who are over 20 years old Patients who have common bile duct stone or cholangitis or obstructive jaundice Patients for whom ERCP and EST are planned Patients who have native papilla
Key exclusion criteria	Patients are to be excluded from this Study if they conflict with any of the criteria shown below Patients who have ampullary tumor Patients who have tumor invasion in the papilla Patients with surgically altered gastrointestinal or pancreatobiliary anatomy Patients who score 4 in Performance Status Patients with serious complication on other organ(s): Higher than 3 with ASA category (dialyzed patients are also excluded) Patients judged to have less than 3 months of life expectancy
Target sample size	40

Research contact person
Name of lead principal investigator	Koji Uno
Organization	Kyoto Second Red Cross Hospital
Division name	Department of Gastroenterology
Address	355-5 Haruobi-cho, Kamigyo-ku, Kyoto 602-8026, Japan
TEL	075-231-5171
Email	unok@kyoto2.jrc.or.jp

Public contact
Name of contact person	Koichiro Mandai
Organization	Kyoto Second Red Cross Hospital
Division name	Department of Gastroenterology
Address	355-5 Haruobi-cho, Kamigyo-ku, Kyoto 602-8026, Japan
TEL	075-231-5171
Homepage URL
Email	mndkchr@gmail.com

Sponsor
Institute	Department of Gastroenterology, Kyoto Second Red Cross Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	2016 Year 10 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 16 Day
Anticipated trial start date	2016 Year 10 Month 18 Day
Last follow-up date	2017 Year 05 Month 13 Day
Date of closure to data entry	2017 Year 05 Month 13 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.gastrores.org/index.php/Gastrores/article/view/974
Results
Other related information

Management information
Registered date	2016 Year 09 Month 25 Day
Last modified on	2018 Year 02 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027800