UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023454 |
|---|---|
| Receipt number | R000026980 |
| Scientific Title | Endoscopic intervention for cholangiopancreatic diseases in patients with Roux-en Y reconstruction: retrospective multicenter study |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2018/02/14 21:38:08 |
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Basic information
Public title
Endoscopic intervention for cholangiopancreatic diseases in patients with Roux-en Y reconstruction: retrospective multicenter study
Acronym
Endoscopic intervention for cholangiopancreatic diseases in patients with Roux-en Y reconstruction
Scientific Title
Endoscopic intervention for cholangiopancreatic diseases in patients with Roux-en Y reconstruction: retrospective multicenter study
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Akio Ido |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Digestive and LifeStyle Diseases,
Zip code
Address
8-35-1, Sakuragaoka, Kagoshima-shi, 890-8520, Japan
TEL
099-275-5326
tag@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Taguchi |
Organization
Saiseikai Sendai Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-46, Haradacho, Satsumasendai-shi, Kagoshima, 895-0075, Japan
TEL
0996-23-5221
Homepage URL
tag@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 18 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026980
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
