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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032608
Receipt No. R000036995
Scientific Title Usefulness of endoscopic ultrasound diagnosis of remnant stone to remove biliary stent after therapy of common bile duct stone and cholecystectomy.
Date of disclosure of the study information 2018/05/16
Last modified on 2019/03/30

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Basic information
Public title Usefulness of endoscopic ultrasound diagnosis of remnant stone to remove biliary stent after therapy of common bile duct stone and cholecystectomy.
Acronym Detection of remnant stone of common bile duct by endoscopic ultrasound.
Scientific Title Usefulness of endoscopic ultrasound diagnosis of remnant stone to remove biliary stent after therapy of common bile duct stone and cholecystectomy.
Scientific Title:Acronym Detection of remnant stone of common bile duct by endoscopic ultrasound.
Region
Japan

Condition
Condition common bile duct stone
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Detection of remnant bile duct stone by EUS when stent removal after endoscopic therapy of bile duct stone.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection of remnant bile duct stone by EUS when stent removal and stone removal.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Evaluate remnant stone by EUS when stentis removal.
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
98 years-old >
Gender Male and Female
Key inclusion criteria Patients performed endoscopic bile duct stone removal and stent placement for bile duct stone or choledocholithic cholangitis.
Key exclusion criteria Patients who are pregnant or have a possibility of pregnancy.
Patients who disagree informed consent.
Patient judged by doctor as inappropriate as subject participant of study.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Ryota
Middle name
Last name Sagami
Organization New Tokyo Hospital
Division name Department of Gastroenterology
Zip code 270-2232
Address 1271 Wanagaya, Matsudo Chiba, Japan
TEL 0477118700
Email sagami1985@yahoo.co.jp

Public contact
Name of contact person
1st name Ryota
Middle name
Last name Sagami
Organization New Tokyo Hospital
Division name Department of Gastroenterology
Zip code 270-2232
Address 1271 Wanagaya, Matsudo Chiba, Japan
TEL 0477118700
Homepage URL
Email sagami1985@yahoo.co.jp

Sponsor
Institute New Tokyo Hospital
Institute
Department

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 New Tokyo Hospital
Address 1271 Wanagaya, Matsudo Chiba, Japan
Tel 0477118700
Email sagami1985@yahoo.co.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
2018 Year 05 Month 16 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
2018 Year 04 Month 23 Day
Date of IRB
2018 Year 04 Month 23 Day
Anticipated trial start date
2018 Year 04 Month 23 Day
Last follow-up date
2021 Year 03 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
2018 Year 05 Month 16 Day
Last modified on
2019 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036995

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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