UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010375 |
|---|---|
| Receipt number | R000012142 |
| Scientific Title | Japan multi-center study: Diagnostic and therapeutic ERC using a short double-balloon endoscope in patients with altered GI anatomy |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2015/02/06 17:03:36 |
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Basic information
Public title
Japan multi-center study:
Diagnostic and therapeutic ERC using a short double-balloon endoscope in patients with altered GI anatomy
Acronym
Japan DB-ERC Study
Scientific Title
Japan multi-center study:
Diagnostic and therapeutic ERC using a short double-balloon endoscope in patients with altered GI anatomy
Scientific Title:Acronym
Japan DB-ERC Study
Region
| Japan |
Condition
Condition
biliary disease
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess efficacy of diagnostic and therapeutic ERC using a short double-balloon endoscope in patients with altered GI anatomy in terms of a researching study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
A success rate of reaching a targeted part (papilla/choledochojejunostomy part)
Key secondary outcomes
1) Judgment of safety (*)
2) A success rate of insertion to deeper parts of a Biliary tract
3) A success rate of treatments relevant to ERC
(*)The outcomes described above are determined by a point of view to assess efficacy of DBE regarding treatments of a Biliary tract for patients with altered GI anatomy.
The items and classifications about safety are determined as follows by a point of view to assess safety of DBE regarding diagnosis and treatment of a Biliary tract for patients with altered GI anatomy.
Grade 1 No problem: There waren't any problems at all.
Grade 2 Light problem: There were light problems during or after examination. But it was not necessary to treat specifically.
Grade 3 Problem: There were some problems during or after examination. And it was necessary to treat specifically or keep patients in observation.
Grade 4 Severe problem: There were severe problems during or after examination. The examination was stopped or should be stopped.
Grade 5 Death due to the trial: To describe a reason.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
double-balloon entdoscope
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
1) Age: 20 years old or older
2) To consent to an inclusion agreement
3) Patients with altered GI anatomy who have a Biliary disease(suspected)(except for gallstone pancreatitis)
Key exclusion criteria
1) Patients with suspected intestinal perforation
2) Patients with anaphylaxis to natural rubber
3) Patients with a very bad general condition
4) Patients having severe blood clotting defect
5) Patients having severe another disease
6) Gravida and possibly pregnant patients
7) Patients whom the chief physician(or the physician in charge) considers to be inappropriate for entry into the trial
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kentaro Sugano, M.D., Ph.D. |
Organization
Jichi Medical University
Division name
Department of Internal Medicine
Zip code
Address
3311-1 Yakushiji, Shimomituke, Tochigi, Japan 329-0498
TEL
0285-58-7347
sugano@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Shimatani |
Organization
Kansai Medicine University
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
2-3-1 Shinmachi, Hirakata-city, Osaka 573-1191, Japan
TEL
072-804-0101
Homepage URL
shimatam@hirakata.kmu.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
FUJIFILM Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
小樽掖済会病院（北海道）、仙台厚生病院（宮城県）、自治医科大学（栃木県）、東京大学（東京都）、名古屋大学(愛知県）、関西医科大学（大阪府）、岡山大学（岡山県）、尾道総合病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | 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
| 2013 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 31 | Day |
Last modified on
| 2015 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012142
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2014/09/07 | DB-ERC：全データ（集計用）140904.xlsx |
