UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Endoscopic intervention for cholangiopancreatic diseases in patients with Roux-en Y reconstruction: retrospective multicenter study
Title of the study (Brief title)	Endoscopic intervention for cholangiopancreatic diseases in patients with Roux-en Y reconstruction
Region	Japan

Condition
Condition	Patients of pancreatobiliary diseases with Roux-en Y reconstruction
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Estimation of the efficacy and safety with endoscopy for pancreatobiliary disease with Roux-en Y reconstruction
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Technical success, Clinical success
Key secondary outcomes	Adverse events, Duration of hospital stay, Entire procedure time, Time reaching for ampulla, Kind of endoscopy

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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who underwent endoscopy for pancreatobiliary diseases after Roux-en Y reconstruction during gastrectomy
Key exclusion criteria	Rejection for participating in the study
Target sample size	100

Research contact person
Name of lead principal investigator	Akio Ido
Organization	Kagoshima University Graduate School of Medical and Dental Sciences
Division name	Digestive and LifeStyle Diseases,
Address	8-35-1, Sakuragaoka, Kagoshima-shi, 890-8520, Japan
TEL	099-275-5326
Email	tag@m2.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person	Hiroki Taguchi
Organization	Saiseikai Sendai Hospital
Division name	Department of Gastroenterology
Address	2-46, Haradacho, Satsumasendai-shi, Kagoshima, 895-0075, Japan
TEL	0996-23-5221
Homepage URL
Email	tag@m2.kufm.kagoshima-u.ac.jp

Sponsor
Institute	Kagoshima University
Institute
Department

Funding Source
Organization	Kagoshima University
Organization
Division
Category of Funding Organization	Japanese Governmental office
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 09 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 18 Day
Anticipated trial start date	2016 Year 09 Month 01 Day
Last follow-up date	2017 Year 06 Month 30 Day
Date of closure to data entry	2017 Year 08 Month 04 Day
Date trial data considered complete	2017 Year 08 Month 10 Day
Date analysis concluded	2018 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	There are neither intervention duration nor observation duration in this study because this study is retrospective study in which the data of patients who underwent endoscopy for pancreatobiliary diseases after Roux-en Y reconstruction are picked up from medical records.

Management information
Registered date	2016 Year 08 Month 03 Day
Last modified on	2018 Year 02 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026980