UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028558 |
|---|---|
| Receipt number | R000032684 |
| Scientific Title | Availability of endoscopic ultrasonography for the diagnosis of choledocholithiasis undetected by other modalities: multicenter non-randomized, non-blind exploratory clinical trial |
| Date of disclosure of the study information | 2017/08/07 |
| Last modified on | 2021/02/08 20:57:35 |
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Basic information
Public title
Availability of endoscopic ultrasonography for the diagnosis of choledocholithiasis undetected by other modalities: multicenter non-randomized, non-blind exploratory clinical trial
Acronym
EUS biliary stone study
Scientific Title
Availability of endoscopic ultrasonography for the diagnosis of choledocholithiasis undetected by other modalities: multicenter non-randomized, non-blind exploratory clinical trial
Scientific Title:Acronym
EUS biliary stone study
Region
| Japan |
Condition
Condition
choledocholithiasis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy of endoscopic ultrasonography on the diagnosis of choledocholithiasis in patients who are suspected of having choledocholithiasis, but cannot be diagnosed by US, CT and MRCP
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of EUS for choledocholithiasis
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) Age of 20 years or older
(2) Suspected of having choledocholithiasis with epigastralgia/ right hypochondralgia due to unknown origin or serum elevated levels of T-bilirubin, AST, ALT, gamma-GT and ALP
(3) Highly suspeted of having choledocholithiasis based on ASGE guideline
(4) Performance Status (PS) Grade 0-3
(5) Being able to providing informed consent for participation
Key exclusion criteria
(1) Having a biliary stone detected by any of US, CT or MRCP
(2) Severe cholangitis (Grade III) based on Tokyo guideline 2013
(3) Bile duct stricture detected by any of US, CT, MRCP
(4) Having the past history of endoscopic treatment of choledocholithiasis
(5) Intubated with a biliary stent
(6) Ampullary tumor
(7) Having tumor invation at the major papilla
(8) With Billroth II or Roux-en-Y reconstruction after gastrectomy
(9) Choledocho-duodenal fistula
(10) Consciousness disturbance with Japan Coma Scale (JCS) I-2 or severe
(11)(12) Severe cardiopulmonary disease
(13) Pregnancy or during breast-feeding
(14) Judged inappropriate by a research director
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
060-8648
Address
North 14, West 5, Kita-ku, Sapporo
TEL
011-716-1161
mkuwatan@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Faculty of Medicine and Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8648
Address
North 15, West 7, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
mkuwatan@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital, Division of Clinical Research Administration
Address
North 14, West 5, Kita-ku, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2017 | Year | 08 | Month | 07 | 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
| 2017 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data as follows are recorded in daily clinical practice and used in the present study. (1) Patient characteristics: height, body weight, illness history, treatment history, age, gender, diagnosis (2) Hematology (3) Serum biochemistry: Total protein, albumin, amylase, lipase, AST, ALT, LDH, gamma-GT, ALP, T-bilirubin, D-bilirubin, fast glucose, creatinine, BUN, Na, K, Cl, Ca, CRP (4) coagulation system: PT-INR (5) ECG, chest radiograph, abdomen radiograph, US, CT, MRCP
Management information
Registered date
| 2017 | Year | 08 | Month | 07 | Day |
Last modified on
| 2021 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032684
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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