UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036357 |
|---|---|
| Receipt number | R000041423 |
| Scientific Title | Randamized control study of EUS versus MRCP for choledocholithiasis that can not be diagnosed by CT. |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2023/10/08 06:02:47 |
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Basic information
Public title
Randamized control study of EUS versus MRCP for choledocholithiasis that can not be diagnosed by CT.
Acronym
Randamized control study of EUS versus MRCP for choledocholithiasis that can not be diagnosed by CT.
Scientific Title
Randamized control study of EUS versus MRCP for choledocholithiasis that can not be diagnosed by CT.
Scientific Title:Acronym
Randamized control study of EUS versus MRCP for choledocholithiasis that can not be diagnosed by CT.
Region
| Japan |
Condition
Condition
choledocholithiasis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the utility of between EUS and MRCP for choledocholithiasis that can not be diagnosed by CT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accracy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with clinical suspicion of choledocholithiasis but a negative CT will be randomly allocated to EUS group.
Interventions/Control_2
Patients with clinical suspicion of choledocholithiasis but a negative CT will be randomly allocated to MRCP group.
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Patients who can not be diagnosed choledocholithiasis by CT.
2.Patients who meet the suspected diagnosis or diagnostic criteria according to Tokyo Guidelines 2018(TG18).
3.Patients with "mild" or "moderate" acute cholangitis,which is defined by TG18.
4.Patients with written informed consent.
Key exclusion criteria
1.Patients who have metal allergy.
2.Patients who have iron hypersensitivity.
3.Altered upper GI anatomy.
4.Patients who have gastrointestinal hemorrhage.
5.Pregnant,unwilling to practice contraception during the study, or lactating female.
6.Patients with "severe" acute cholangitis,which is defined by TG18.
7.Patients considered ineligible for this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Masato |
| Middle name | |
| Last name | Suzuki |
Organization
Yokohama Rosai Hospital
Division name
Department of Gastroenterology
Zip code
222-0036
Address
3211,Kozukue-cho,Kouhoku-ku,Yokohama-shi,Kanagawa
TEL
045-474-8111
d07sm056@gmail.com
Public contact
Name of contact person
| 1st name | Masato |
| Middle name | |
| Last name | Suzuki |
Organization
Yokohama Rosai Hospital
Division name
Department of Gastroenterology
Zip code
222-0036
Address
3211,Kozukue-cho,Kohoku-ku,Yokohama-city,Kanagawa
TEL
045-474-8111
Homepage URL
d07sm056@gmail.com
Sponsor or person
Institute
Yokohama Rosai Hospital,Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
none
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
Yokohama Rosai Hospital
Address
3211,Kozukue-cho,Kouhoku-ku,Yokohama-shi,Kanagawa
Tel
045-474-8111
none
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
| 2019 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/34784076/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34784076/
Number of participants that the trial has enrolled
50
Results
The accuracy was 92.3% for EUS and 68.4% for MRCP (P = 0.055). EUS showed 100% sensitivity, 88.2% specificity, 81.8% positive predictive value, and 100% negative predictive value, and MRCP showed 33.3% sensitivity, 84.6% specificity, 50% positive predictive value, and 73.3% negative predictive value. The CBDS detection rate in the second examination was 0% for MRCP after a negative EUS and 35.7% for EUS after a negative MRCP (P = 0.041).
Results date posted
| 2023 | Year | 10 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who visited the Yokohama Rosai Hospital between April 2019 and January 2021 for suspected CBDS were enrolled in this trial.
Participant flow
Patients suspected of having CBDS were enrolled and randomly allocated to the EUS or MRCP group. Upon the initial examination, those having CBDS or sludge formation underwent endoscopic retrograde cholangiopancreatography (ERCP), while those who were CBDS-negative underwent a second examination with either MRCP or EUS, which was distinct from the initial diagnostic procedure.
Adverse events
No adverse events occurred in any of the patients.
Outcome measures
The primary outcome was diagnostic accuracy, and the secondary outcomes were diagnostic ability, detection rate and characteristics of CBDS in the second examination, and the frequency of adverse events.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2021 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 03 | Month | 31 | Day |
Last modified on
| 2023 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041423
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