UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042435 |
|---|---|
| Receipt number | R000048444 |
| Scientific Title | Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture |
| Date of disclosure of the study information | 2020/11/13 |
| Last modified on | 2020/11/12 22:04:38 |
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Basic information
Public title
Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture
Acronym
Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture
Scientific Title
Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture
Scientific Title:Acronym
Role of peroral cholangioscopy in addition to computed tomography in management of indeterminate biliary stricture
Region
| Japan |
Condition
Condition
biliary stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
evaluate additional effect of peroral cholangioscope to computed tomography on diagnosis of biliary strictures and tumor spread
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in agreement between the evaluation of CT and ERCP images and that with POCSadded to the final diagnosis
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
1) A case in which biliary stricture was diagnosed by dynamic CT and ERCP was performed at our hospital for the purpose of benign / malignant diagnosis or tumor spread
2) performing a four-phase CT without pneumobilia and biliary stent.
3) using video cholangioscope.
4) performing CT and POCS within sixty days.
Key exclusion criteria
1) pancreatic disease and tumor of duodenal papilla diagnosed without POCS.
2) patients who did not undergo radical resection or were treated before surgery for malignant disease.
3) patients who underwent follow-up of less than three years for benign disease.
4) anastomotic stricture diagnosed with medical history.
5) biliary strictures by primary hepatic cancer and metastatic tumor.
6) pancreaticobiliary maljunction without findings to suggest malignancy.
7) A case in which there was an offer to refuse participation in this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Kato |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Gastroenterology
Zip code
260-8677
Address
Inohana 1-8-1, Chiba-City, Japan.
TEL
043-222-7171
kato.naoya@chiba-u.jp
Public contact
Name of contact person
| 1st name | Yukiko |
| Middle name | |
| Last name | Shima |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Gastroenterology
Zip code
260-8677
Address
Inohana 1-8-1, Chiba-City, Japan.
TEL
043-222-7171
Homepage URL
shimako1029@gmail.com
Sponsor or person
Institute
Department of Gastroenterology, Graduate School of Medicine, Chiba University.
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Graduate School of Medicine, Chiba University.
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
Chiba University Certified Review Board
Address
Inohana 1-8-1, Chiba-City, Japan.
Tel
043-222-7171
igaku-rinri@office.chiba-u.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
3608
Org. issuing International ID_1
Chiba University Certified Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 13 | 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
52
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
| 2019 | Year | 11 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 09 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 09 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 09 | Day |
Date analysis concluded
Other
Other related information
This research is retrospective cohort study.
Management information
Registered date
| 2020 | Year | 11 | Month | 12 | Day |
Last modified on
| 2020 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048444
