UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of diagnostic and therapeutic ERCP using a short double-balloon enteroscope
Title of the study (Brief title)	Efficacy and safety of ERCP using a short double-balloon enteroscope
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of diagnostic and therapeutic ERCP using a short double-balloon enteroscope.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Technical success rate of the diagnostic and therapeutic ERCP
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	Double-balloon enteroscope
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	1, Postoperative surgical patients with pancreatobiliary disease. 2, Patients of age =>20. 3, Written informed consent is required from all patients.
Key exclusion criteria	1, Patients with serious complication in other organ. 2, Patients with severe general condition. 3, Patients who don't give informed consent. 4, Inappropriate patients for entry on this study in the judgement of the investigator.
Target sample size	70

Research contact person
Name of lead principal investigator	Hironari Kato
Organization	Okayama University Hospital
Division name	Department of Gastroenterology and Hepatology
Address	2-5-1 Shikata-cho, Kita-ku, Okayama-city, Okayama, Japan, 700-8558
TEL	086-235-7219
Email	drkatocha@yahoo.co.jp

Public contact
Name of contact person	Koichiro Tsutsumi
Organization	Okayama University Hospital
Division name	Department of Gastroenterology and Hepatology
Address	2-5-1 Shikata-cho, Kita-ku, Okayama, Japan, 700-8558
TEL	086-235-7219
Homepage URL
Email	tsutsumi@cc.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	Okayama 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

Other administrative information
Date of disclosure of the study information	2014 Year 05 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 06 Month 26 Day
Anticipated trial start date	2012 Year 06 Month 26 Day
Last follow-up date
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded	2016 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/25041448
Results
Other related information

Management information
Registered date	2014 Year 05 Month 13 Day
Last modified on	2016 Year 12 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015625