UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056308 |
|---|---|
| Receipt number | R000064342 |
| Scientific Title | A prospective observational study of transpapillary biopsy using a novel guidewire-guided biopsy forceps for malignant biliary strictures |
| Date of disclosure of the study information | 2024/11/29 |
| Last modified on | 2024/11/29 15:38:35 |
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Basic information
Public title
A prospective observational study of transpapillary biopsy for malignant biliary strictures
Acronym
A prospective observational study of transpapillary biopsy for malignant biliary strictures
Scientific Title
A prospective observational study of transpapillary biopsy using a novel guidewire-guided biopsy forceps for malignant biliary strictures
Scientific Title:Acronym
A prospective observational study of transpapillary biopsy using a novel guidewire-guided biopsy forceps for malignant biliary strictures
Region
| Japan |
Condition
Condition
malignant biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to prospectively evaluate the efficacy of transpapillary biopsy using a novel guidewire-guided biopsy forceps for malignant biliary strictures
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
technical success rate of biopsy for biliary strictures
Key secondary outcomes
accuracy rate of histological diagnosis for bile duct stricture
success rate of obtaining adequate biopsy sample
time required for biopsies for bile duct stricture
rate of adverse events
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who underwent transpapillary biopsy for malignant biliary strictures using a novel guidewire-guided biopsy forceps during ERCP
Key exclusion criteria
patients with postoperative reconstruction of the upper gastrointestinal tract
biliary stricture located upstream of the common hepatic duct
when performing biopsy by a beginner in ERCP
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toji |
| Middle name | |
| Last name | Murabayashi |
Organization
Ise Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
5168512
Address
1-471-2, Funae, Ise, Mie
TEL
0596-28-2171
murabayashitoji@m2.gmobb.jp
Public contact
Name of contact person
| 1st name | Toji |
| Middle name | |
| Last name | Murabayashi |
Organization
Ise Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
516-8512
Address
1-471-2, Funae, Ise, Mie
TEL
0596-28-2171
Homepage URL
murabayashitoji@m2.gmobb.jp
Sponsor or person
Institute
Ise Red Cross Hospital
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
Institutional Review Board at Ise Red Cross Hospital
Address
1-471-2, Funae, Ise, Mie
Tel
0596-28-2171
jimubu@ise.jrc.or.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 | 11 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 10 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective multicenter study
Management information
Registered date
| 2024 | Year | 11 | Month | 29 | Day |
Last modified on
| 2024 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064342
