UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050972 |
|---|---|
| Receipt number | R000057422 |
| Scientific Title | Pancreatic drainage comparison between pancreatic stent and endoscopic nasal pancreatic drainage tube during endoscopic papillectomy |
| Date of disclosure of the study information | 2023/05/02 |
| Last modified on | 2025/05/01 10:02:50 |
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Basic information
Public title
Pancreatic drainage comparison between pancreatic stent and endoscopic nasal pancreatic drainage tube during endoscopic papillectomy
Acronym
Pancreatic drainage comparison between pancreatic stent and endoscopic nasal pancreatic drainage tube during endoscopic papillectomy
Scientific Title
Pancreatic drainage comparison between pancreatic stent and endoscopic nasal pancreatic drainage tube during endoscopic papillectomy
Scientific Title:Acronym
Pancreatic drainage comparison between pancreatic stent and endoscopic nasal pancreatic drainage tube during endoscopic papillectomy
Region
| Japan |
Condition
Condition
major papillary tumor
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of pancreatic drainage during endoscopic papillectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pancreatitis after endoscopic papillectomy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
pancreatic duct stent
Interventions/Control_2
endoscopic nasal pancreatic drainage
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
the patients who agree the examination
Key exclusion criteria
those who don't agree the examination
impossible to drainage pancreatic duct
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Kawasaki |
Organization
Keio University School of medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-0016
Address
35 Shinanomachi Shinjuku Tokyo
TEL
03-3353-1211
e-iwa@keio.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Kawasaki |
Organization
Keio University School of Medicine
Division name
Center for Diagnostic and Therapeutic Endoscopy
Zip code
160-0016
Address
35 Shinanomachi Shinjuku Tokyo
TEL
03-3353-1211
Homepage URL
http://www.keio-med.jp/gastro/
s.kawasaki@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
Keio University Hospital Clinical Researchi Administration Center
Address
35 Shinanomachi Shinjuku Tokyo Japan
Tel
03-3353-1211
keio@esct.bvits.com
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
| 2023 | Year | 05 | Month | 02 | 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
Suspended
Date of protocol fixation
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 01 | Day |
Last modified on
| 2025 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057422
