UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062845 |
|---|---|
| Receipt number | R000071841 |
| Scientific Title | Endoscopic Ultrasound (EUS) versus Magnetic Resonance Cholangiopancreatography (MRCP) for CT-Indeterminate Common Bile Duct Stones: A Multicenter Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/08 13:25:53 |
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Basic information
Public title
Endoscopic Ultrasound (EUS) versus Magnetic Resonance Cholangiopancreatography (MRCP) for CT-Indeterminate Common Bile Duct Stones: A Multicenter Randomized Controlled Trial
Acronym
EMSTONE Trial
Scientific Title
Endoscopic Ultrasound (EUS) versus Magnetic Resonance Cholangiopancreatography (MRCP) for CT-Indeterminate Common Bile Duct Stones: A Multicenter Randomized Controlled Trial
Scientific Title:Acronym
EMSTONE Trial
Region
| Japan |
Condition
Condition
Patients in which the presence of common bile duct stones is suspected due to elevated biliary enzymes but cannot be clearly confirmed on CT, and in which elective endoscopic stone removal will be performed if stones are present.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and evaluate the diagnostic performance and usefulness of EUS versus MRCP for common bile duct stones that are difficult to diagnose on CT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare the diagnostic accuracy of the initial examination (EUS versus MRCP) for the diagnosis of common bile duct stones that cannot be identified on CT.
Key secondary outcomes
To evaluate the diagnostic performance (sensitivity, specificity, positive predictive value, and negative predictive value) of EUS and MRCP as the primary examination.
To evaluate the detection rate of common bile duct stones by EUS and MRCP as the secondary examination.
To evaluate the incidence of adverse events associated with EUS and MRCP.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Intervention1(EUS group):
Patients allocated to this group undergo EUS as the initial examination. The presence or absence of common bile duct stones (including size and number when present) is recorded. If stones are suspected, ERCP is performed and the final diagnosis is made based on ERCP findings. If no stones are detected, MRCP is performed as the secondary examination.
Interventions/Control_2
Intervention2(MRCP group):
Patients allocated to this group undergo MRCP as the initial examination. The presence or absence of common bile duct stones (including size and number when present) is recorded. If stones are suspected, ERCP is performed and the final diagnosis is made based on ERCP findings. If no stones are detected, EUS is performed as the secondary examination.
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
1. Patients aged 18 years or older at the time of obtaining consent
2. Patients in whom common bile duct stones cannot be clearly identified on CT
3. Patients with suspected or definite diagnosis of acute cholangitis according to the diagnostic criteria in the Tokyo Guidelines 2018 (Guidelines for the management of acute cholangitis and cholecystitis)
4. Patients with mild or moderate acute cholangitis according to the severity grading in the Tokyo Guidelines 2018 (Guidelines for the management of acute cholangitis and cholecystitis)
5. Patients from whom informed consent has been obtained
Key exclusion criteria
1. Patients who are pregnant, possibly pregnant, or breastfeeding
2. Patients in whom endoscopy (EUS) is difficult to perform
3. Patients in whom MRI is difficult to perform due to claustrophobia or metal implants in the body
4. Patients with ECOG Performance Status 4
5. Patients with severe comorbidities of ASA class 4 or higher (cardiac, pulmonary, renal, hepatic disease, etc.)
6. Patients with surgically altered gastrointestinal anatomy other than Billroth-I reconstruction
7. Patients with gallstone pancreatitis
8. Patients with concomitant bile duct stricture
9. Patients judged to be inappropriate for enrollment at the physician's discretion
Target sample size
112
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Kitano |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama City, Wakayama
TEL
073-447-2300
itonaga@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoya |
| Middle name | |
| Last name | Emori |
Organization
Wakayama Medical University
Division name
Second Department of Internal Medicine
Zip code
641-0012
Address
811-1 Kimiidera, Wakayama City, Wakayama
TEL
073-447-2300
Homepage URL
t-emori@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Kansai Endoscopic Device Selection Conference in the Kansai Research Group
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama
Tel
073-447-2300
wa-rinri@wakayama-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 09 | Month | 08 | Day |
Last modified on
| 2026 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071841
