UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025631
Receipt No. R000029487
Scientific Title Retrospective study of clinical utility of Endoscopic Retrograde Cholangiopancreatography and relative for digestive diseases.
Date of disclosure of the study information 2017/01/12
Last modified on 2017/01/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Retrospective study of clinical utility of Endoscopic Retrograde Cholangiopancreatography and relative for digestive diseases.
Acronym Retrospective study of clinical utility of ERCP and relative.
Scientific Title Retrospective study of clinical utility of Endoscopic Retrograde Cholangiopancreatography and relative for digestive diseases.
Scientific Title:Acronym Retrospective study of clinical utility of ERCP and relative.
Region
Japan

Condition
Condition digestive diseases
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical utility and safety of ERCP and relative for digestive diseases retrospectively.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes A technical and clinical success rate
Key secondary outcomes Complications, Long term follow up

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 The case that performed ERCP and relative.
Key exclusion criteria ´ŻąThe case that ERCP images are not recorded sufficiently.
´ŻąThe case that follow-up of clinical course is difficult.
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Kawashima
Organization Nagoya University Graduate School of Medicine
Division name Gastroenterology and Hepatology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-741-2111
Email h-kawa@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Kawashima
Organization Nagoya University Graduate School of Medicine
Division name Gastroenterology and Hepatology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-741-2111
Homepage URL
Email h-kawa@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Nagoya University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 01 Month 12 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 05 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate the utility of ERCP and relative retrospectively.

Management information
Registered date
2017 Year 01 Month 11 Day
Last modified on
2017 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029487

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.