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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028558
Receipt No. 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 2017/08/07

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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
Middle name
Last name Masaki Kuwatani
Organization Hokkaido University Hospital
Division name Division of Endoscopy
Zip code
Address North 14, West 5, Kita-ku, Sapporo
TEL 011-716-1161
Email mkuwatan@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Kuwatani
Organization Hokkaido University Faculty of Medicine and Graduate School of Medicine
Division name Department of Gastroenterology and Hepatology
Zip code
Address North 15, West 7, Kita-ku, Sapporo
TEL 011-716-1161
Homepage URL
Email mkuwatan@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 28 Day
Last follow-up date
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
2017 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032684

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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