UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030898 |
|---|---|
| Receipt number | R000035281 |
| Scientific Title | The strategy of endoscopic intervention for pancreatic fluid collection |
| Date of disclosure of the study information | 2018/01/19 |
| Last modified on | 2022/07/24 13:50:27 |
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Basic information
Public title
The strategy of endoscopic intervention for pancreatic fluid collection
Acronym
The strategy of endoscopic intervention for pancreatic fluid collection
Scientific Title
The strategy of endoscopic intervention for pancreatic fluid collection
Scientific Title:Acronym
The strategy of endoscopic intervention for pancreatic fluid collection
Region
| Japan |
Condition
Condition
Pancreatic fluid collection after acute pancreatitis (Pancreatic pseudocyst; PPC, Walled-off necrosis; WON)
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of EUS-guided transluminal drainage (EUS-TD) and step up approach for PPC or WON
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical success rate of EUS-TD and step up
approach
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient with done EUS-TD for PPC/WON
Key exclusion criteria
Patient with done EUS-TD for disease other than PPC/WON
Target sample size
76
Research contact person
Name of lead principal investigator
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Masuda |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Gastroenterology, Department of Internal medicine
Zip code
6570013
Address
chu-oku, kusunoki-cho, 7-5-2
TEL
078-382-6305
atmasuda@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Tsujimae |
Organization
KOBE UNIVERSITY
Division name
Division of Gastroenterology, Department of Internal medicine
Zip code
6570013
Address
chu-oku, kusunoki-cho, 7-5-2
TEL
078-382-6305
Homepage URL
tsujimae@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Kobe Univ. Hosp. Clinical and Translational Research Center
Address
Kusunoki-cho 7-5-2, Chuo-ku, Kobe
Tel
078-382-5400
kansatsu@med.kobe-u.ac.jp
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
| 2018 | Year | 01 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 01 | Month | 19 | Day |
Last modified on
| 2022 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035281
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
