UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054678 |
|---|---|
| Receipt number | R000062482 |
| Scientific Title | Can early NKPP reduce PEP in patients with difficult bile duct cannulation? A single-center retrospective study |
| Date of disclosure of the study information | 2024/06/17 |
| Last modified on | 2024/12/21 11:19:43 |
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Basic information
Public title
Can early NKPP reduce PEP in patients with difficult bile duct cannulation?
A single-center retrospective study
Acronym
Can early NKPP reduce PEP in patients with difficult bile duct cannulation?
A single-center retrospective study
Scientific Title
Can early NKPP reduce PEP in patients with difficult bile duct cannulation?
A single-center retrospective study
Scientific Title:Acronym
Can early NKPP reduce PEP in patients with difficult bile duct cannulation?
A single-center retrospective study
Region
| Japan |
Condition
Condition
bile duct disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the association between NKPP and post-ERCP pancreatitis during ERCP in our hospital.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence rate of post-ERCP pancreatitis
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
The retrospective study spanned the period from November 2011 through December 2021 at the Kawasaki University General Medical Center. It encompassed 1556 patients, aged >20 years, who underwent their initial ERCP attempt for biliary disease with a naive papilla at our hospital.
Key exclusion criteria
Postoperative reconstructed intestinal tract
Target sample size
1556
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Tanikawa |
Organization
Kawasaki Medical Schoo
Division name
Department of General Internal Medicine 2
Zip code
700-8505
Address
2-6-1, Nakasange, Kita-ku, Okayama
TEL
086-225-2111
t-tanikawa@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Tanikawa |
Organization
Kawasaki Medical Schoo
Division name
Department of General Internal Medicine 2
Zip code
700-8505
Address
2-6-1, Nakasange, Kita-ku, Okayama
TEL
0862252111
Homepage URL
t-tanikawa@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School
Address
577, Matsushima, Kurashiki, Okayama
Tel
086-462-1111
t-tanikawa@med.kawasaki-m.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
| 2024 | Year | 06 | Month | 17 | 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
1556
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
| 2023 | Year | 02 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 06 | Month | 17 | Day |
Last modified on
| 2024 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062482
