UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of short-type single-balloon enteroscopy-assisted ERCP in patients with surgically altered anatomy: Factors affecting technical difficulty
Title of the study (Brief title)	Efficacy and factors affecting technical difficulty of short-SBE assisted ERCP
Region	Japan

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

Objectives
Narrative objectives1	To examine the procedural success rate of short-SBE assisted ERCP and factors affecting technical difficulty.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Procedural success rate of short SBE assisted ERCP.
Key secondary outcomes	Factors that affect enteroscopy and procedural failure.

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 altered upper GI anatomy who underwent short-SBE assisted ERCP
Key exclusion criteria	1, Patients whom the principal investigator considered to be inappropriate for this study
Target sample size	100

Research contact person
Name of lead principal investigator	Kei Yane
Organization	Teine-Keijinkai Hospital
Division name	Center for Gastroenterology
Address	1-jo, 12-chome, Maeda, Teine-ku, Sapporo
TEL	011-681-8111
Email	k.yane3@gmail.com

Public contact
Name of contact person	Kei Yane
Organization	Teine-Keijinkai Hospital
Division name	Center for Gastroenterology
Address	1-jo, 12-chome, Maeda, Teine-ku, Sapporo
TEL	011-681-8111
Homepage URL
Email	k.yane3@gmail.com

Sponsor
Institute	Center for Gastroenterology, Teine-Keijinkai Hospital
Institute
Department

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	2016 Year 02 Month 15 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 08 Month 10 Day
Anticipated trial start date	2016 Year 02 Month 15 Day
Last follow-up date	2016 Year 02 Month 29 Day
Date of closure to data entry	2016 Year 03 Month 31 Day
Date trial data considered complete	2016 Year 03 Month 31 Day
Date analysis concluded	2016 Year 04 Month 23 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.thieme-connect.de/products/ejournals/abstract/10.1055/s-0042-118301
Results
Other related information	Observational study Patients: All patients with surgically altered anatomy who underwent ERCP using prototype short SBEs in Teine keijinkai hospital between June 2011 and November 2015. Methods: We retrospectively examined the procedural success rate of ERCP and the risk factors that could affect procedural failure.

Management information
Registered date	2016 Year 02 Month 14 Day
Last modified on	2017 Year 02 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024256