UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045822 |
|---|---|
| Receipt number | R000052304 |
| Scientific Title | Observational study of biliary and pancreatic endoscopy using a new double-balloon endoscopy |
| Date of disclosure of the study information | 2021/10/22 |
| Last modified on | 2024/04/26 13:52:05 |
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Basic information
Public title
Observational study of biliary and pancreatic endoscopy using a new double-balloon endoscopy
Acronym
Observational study of biliary and pancreatic endoscopy using a new double-balloon endoscopy
Scientific Title
Observational study of biliary and pancreatic endoscopy using a new double-balloon endoscopy
Scientific Title:Acronym
Observational study of biliary and pancreatic endoscopy using a new double-balloon endoscopy
Region
| Japan |
Condition
Condition
Bile duct or pancreatic duct stenosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the rate of arrival at the target site, the rate of procedural success, and the rate of clinical success in biliary and pancreatic endoscopic treatment with a new double-balloon endoscopy (Ei-580BT) in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Target site arrival rate, procedural success rate, clinical success rate
Key secondary outcomes
Adverse event rate
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
1) Because of the postoperative reconstructed intestinal tract, it is usually difficult to perform biliary and pancreatic endoscopy with a normal endoscope, and double-balloon enteroscopy is required.
2) Clinically and imaginary, biliary and pancreatic endoscopy is required.
Key exclusion criteria
1)The physician determines that the patient's enrollment in the study is inappropriate because endoscopy is difficult.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Hijioka |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
shijoka@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kawasaki |
Organization
National Cancer Center Hospital
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
yukikawa@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
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
National Cancer Center Hospital
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
shijoka@ncc.go.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
| 2021 | Year | 10 | Month | 22 | 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
| 2021 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
To clarify the rate of arrival at the target site, the rate of procedural success, and the rate of clinical success in biliary and pancreatic endoscopic treatment with a new double-balloon endoscopy (EI-580BT).
Management information
Registered date
| 2021 | Year | 10 | Month | 21 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052304
