UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039494 |
|---|---|
| Receipt number | R000045037 |
| Scientific Title | Verification for the efficacy of S-shaped pancreatic stent against straight type |
| Date of disclosure of the study information | 2020/02/16 |
| Last modified on | 2021/04/16 09:15:41 |
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Basic information
Public title
Verification for the efficacy of S-shaped pancreatic stent
Acronym
The efficacy of S-shaped pancreatic stent
Scientific Title
Verification for the efficacy of S-shaped pancreatic stent against straight type
Scientific Title:Acronym
The efficacy of S-shaped pancreatic stent
Region
| Japan |
Condition
Condition
chronic pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the obstructive rate of S-shaped pancreatic stent, and compared to straight type.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Obstructive rate of S-shaped pancreatic stent
Period: 3 months
Key secondary outcomes
Efficacy of S-shaped pancreatic stent against straight type. Furthermore, verify the reasons, and calculate patency period.
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
Patients who undergo endoscopic pancreatic stenting (EPS) against main pancreatic duct stricture.
Key exclusion criteria
1) Patients who disagree with the study. We use the opt-out method for the consent.
2) Main pancreatic duct stricture is too tight for EPS.
3) Physician decided the patient is unsuitable for the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuki |
| Middle name | |
| Last name | Hori |
Organization
Nagoya City University Graduate School
of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya, Japan
TEL
0528538211
yhori@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yasuki |
| Middle name | |
| Last name | Hori |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya, Japan
TEL
0528538211
Homepage URL
yhori@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
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
The IRB of Nagoya City University
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya, Japan
Tel
+81528587215
clinical_research@med.nagoya-cu.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
| 2020 | Year | 02 | Month | 16 | 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
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 07 | Month | 01 | Day |
Other
Other related information
Completed
Management information
Registered date
| 2020 | Year | 02 | Month | 16 | Day |
Last modified on
| 2021 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045037
