UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective randomized controlled multicenter trial of precut and endoscopic ultrasound-guided rendezvous procedure: effect on selective bile duct cannulation in difficult bile duct cannulation using conventional technique
Title of the study (Brief title)	A randomized trials of precut vs EUS-rendezvous
Region	Japan

Condition
Condition	Pancreatobiliary diseases
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the successful biliary cannulation of precut and EUS-rendezvous in patients with difficult cannulation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Selective biliary cannulation
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Precut
Interventions/Control_2	EUS-rendezous
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	First time ERCP for biliary cannulation
Key exclusion criteria	PS4 JCS>1 NYHA III, IV SpO2 < 90% Pregnancy Age <20 Contraindication for endoscopy Pancreatico biliary maljunction Post gastrectomy Acute pancreatitis Chronic pancreatitis Biliary stone impaction Ampullary tumor Previous PTBD Allergy to contrast media
Target sample size	194

Research contact person
Name of lead principal investigator	Hiroshi Kawakami
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	Kita15, Nishi7, Sapporo, Japan
TEL	011-716-1161
Email	hiropon@med.hokudai.ac.jp

Public contact
Name of contact person	Kazumichi Kawakubo
Organization	Hokkaido University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	Kita15, Nishi7, Sapporo, Japan
TEL	011-716-2111
Homepage URL
Email	kkawakubo-gi@umin.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
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	2014 Year 05 Month 09 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 09 Day
Anticipated trial start date	2015 Year 01 Month 14 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	2014 Year 05 Month 09 Day
Last modified on	2016 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016230