UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052646 |
|---|---|
| Receipt number | R000060076 |
| Scientific Title | Study to establish appropriate protocols for cholangiocarcinoma in Dynamic-CT |
| Date of disclosure of the study information | 2023/10/30 |
| Last modified on | 2023/10/30 09:07:35 |
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Basic information
Public title
Study to establish appropriate protocols for cholangiocarcinoma in Dynamic-CT
Acronym
Study to establish appropriate protocols for cholangiocarcinoma in Dynamic-CT
Scientific Title
Study to establish appropriate protocols for cholangiocarcinoma in Dynamic-CT
Scientific Title:Acronym
Study to establish appropriate protocols for cholangiocarcinoma in Dynamic-CT
Region
| Japan |
Condition
Condition
extrahepatic cholangiocarcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively explore appropriate protocols in the evaluation of extrahepatic cholangiocarcinoma for subjective assessment and diagonostic performance by radiologists in cases with a confirmed diagnosis of cholangiocarcinoma, and contrasting findings on Dynamic-CT with pathology findings.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary site of cholangiocarcinoma (if in the hilar region, also evaluate the Bismuth classification)
Evaluation of horizontal extension in each imaging phase.
Direction of horizontal extension (duodenal or hepatic).
Evaluation of vascular invasion in each contrast-enhanced phase.
Evaluation of adjacent organ invasion in each imaging phase (liver, pancreas, duodenum)
Subjective assessment of contrast effect in each contrast phase(5-point scale).
Objective assessment in each contrast phase(measurement of CT values).
Measurement of scan delay ratio in each contrast phase.
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
Patients who underwent surgery at Iwate Medical University Hospital or affiliated Uchimaru MC between January 1, 2011 and December 31, 2021, and had a pathologically confirmed diagnosis of cholangiocarcinoma.
Cases in which CT was taken before treatment (bile duct stent, surgical resection, chemotherapy).
Patients diagnosed with cholangiocarcinoma by pathological examination, whether preoperative or postoperative.
Patients must be at least 20 years of age.
No gender restriction.
Key exclusion criteria
Cases in which CT was taken but no protocol was described, such as the timing of the CT.
EHD cancer was not the clinical diagnosis.
Cases with confirmed reduced renal function (eGFR < 45 mL/min/1.73 m2).
Patients who refused to participate in the study by opting out.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akio |
| Middle name | |
| Last name | Tamura |
Organization
Iwate Medical University School of Medicine.
Division name
Department of Radiology
Zip code
028-3695
Address
2-1-1, Idaidoori, Yahaba Town, Shiwa-gun, Iwate, Japan
TEL
019-613-7111
akahane@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Eisuke |
| Middle name | |
| Last name | Mukaida |
Organization
Iwate Medical University School of Medicine.
Division name
Department of Radiology
Zip code
028-3695
Address
2-1-1, Idaidoori, Yahaba Town, Shiwa-gun, Iwate, Japan
TEL
019-613-7111
Homepage URL
mukaida@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University School of Medicine.
Institute
Department
Personal name
Eisuke Mukaida
Funding Source
Organization
Department of Radiology, Iwate Medical University School of Medicine.
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
Iwate Medical University School of Medicine.
Address
2-1-1, Idaidoori, Yahaba Town, Shiwa-gun, Iwate, Japan
Tel
019-613-7111
mukaida@iwate-med.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
岩手医科大学附属病院（岩手県）、岩手医科大学内丸メディカルセンター（岩手県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 30 | 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
120
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
| 2022 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study will include objective assessment and diagnostic performance on patients selected according to the eligibility and exclusion criteria described separately.
Management information
Registered date
| 2023 | Year | 10 | Month | 30 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060076
