UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008290 |
|---|---|
| Receipt number | R000009769 |
| Scientific Title | Comparison of pancreatitis-preventing effects between pancreatic duct stents with different lengths |
| Date of disclosure of the study information | 2012/07/01 |
| Last modified on | 2018/08/15 13:08:12 |
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Basic information
Public title
Comparison of pancreatitis-preventing effects between pancreatic duct stents with different lengths
Acronym
pancreatitis-preventing effects of stents with different lengths
Scientific Title
Comparison of pancreatitis-preventing effects between pancreatic duct stents with different lengths
Scientific Title:Acronym
pancreatitis-preventing effects of stents with different lengths
Region
| Japan |
Condition
Condition
pancreatic or biliary disorders needing ERCP
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate difference in pancreatitis-preventing effects between stants with different lengths
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
occurrence rate of post-ERCP pancreatitis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
3cm-pancreatic stent
Interventions/Control_2
5cm-pancreatic stent
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
Cases undergoing ERCP who have either 1.history of post-ERCP pancreatitis, 2.difficulty in bile duct cannulation, 3.use of pancreatic duct guide wire, 4.papillary dilatation or EST, 5.invasive treatment against pancreas
Key exclusion criteria
failure to obtain written informed consent
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Matsuhashi |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastroenterology
Zip code
Address
5-9-22 Higashi-gotanda, shinagawa-ku, Tokyo
TEL
81334486245
nmatuha-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Matsuhashi |
Organization
NTT Medical Center Tokyo
Division name
Department of Gastroenterology
Zip code
Address
5-9-22 Higashi-gotanda, shinagawa-ku, Tokyo
TEL
81334486245
Homepage URL
nmatuha-tky@umin.ac.jp
Sponsor or person
Institute
NTT Medical Center Tokyo
Institute
Department
Personal name
Funding Source
Organization
NTT Medical Center Tokyo
Organization
Division
Category of Funding Organization
Profit organization
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
| 2012 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 06 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 28 | Day |
Last modified on
| 2018 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009769
