UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Techique of scope insertion for ERCP using a double-balloon enteroscope in patients with Roux-en Y hepaticojejunostomy: comparison of X-ray imagings for efficient procedure
Title of the study (Brief title)	Technique of scope insertion for ERCP using a double-balloon enteroscope in patients with Roux-en Y hepaticojejunostomy
Region	Japan

Condition
Condition	Biliary tract disease
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of the comparison of the X-ray imagings for selection of the correct lumen which leads the scope to the bilioenteric anastomosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of reaching the bilioenteric anastomosis accurately by the comparison of the X-ray imagings
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1, Patients with Roux-en Y hepaticojejunostomy and bile tract disease. 2, Written informed consent is required from patients or legal representatives
Key exclusion criteria	1, Patients who have difficulty in endoscopic approach. 2, Patients in ECOG performance status 4. 3, Patients with serious complication in other organ. 4, Patients who have side-to-side jejunojejunal anastomosis. 5, Patients who don't give informed consent.
Target sample size	32

Research contact person
Name of lead principal investigator	Hironari Kato
Organization	Okayama University Hospital
Division name	Department of Gastroenterology and Hepatolog
Address	2-5-1 Shikata-cho, Kita-ku, 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	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	岡山大学病院（岡山県）、広島市立広島市民病院（広島県）

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 26 Day
Anticipated trial start date	2014 Year 03 Month 26 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.thieme-connect.com/DOI/DOI?10.1055/s-0043-117406
Results
Other related information	Prospective study for the assessment of the efficacy of the comparison of the X-ray imagings for selection of the correct lumen which leads the scope to the bilioenteric anastomosis in patients with Roux-en Y hepaticojejunostomy.

Management information
Registered date	2014 Year 06 Month 06 Day
Last modified on	2017 Year 12 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016255