UMIN-CTR Clinical Trial

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
Email	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
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	Hokkaido University Hospital, Division of Clinical Research Administration
Address	North 14, West 5, Kita-ku, Sapporo
Tel	011-706-7636
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032684