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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035904
Receipt No. R000040897
Scientific Title Randomized controlled trial of newly designed basket catheter versus balloon catheter for removal of bile duct stones
Date of disclosure of the study information 2019/02/18
Last modified on 2019/02/16

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Basic information
Public title Randomized controlled trial of newly designed basket catheter versus balloon catheter for removal of bile duct stones
Acronym Randomized controlled trial of removal of biliary stones.
Scientific Title Randomized controlled trial of newly designed basket catheter versus balloon catheter for removal of bile duct stones
Scientific Title:Acronym Randomized controlled trial of removal of biliary stones.
Region
Japan

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

Objectives
Narrative objectives1 To investigate superiority of stone removal of newly designed basket catheter
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rate of complete removal of stones within 10 minutes
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Stone removal using newly designed basket catheter
Interventions/Control_2 Stone removal using balloon catheter
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. Bile duct stones less than 10mm in imaging diagnosis
2. Ability to understand and willingness to sign a written statement of informed consent
Key exclusion criteria 1. Surgically altered upper gastrointestinal anatomy except for Billroth I
2. Difficulty of ERCP because of upper gastrointestinal, pancreatic, or biliary malignancy
3. Stenosis of extrahepatic bile duct
4. Coexistence of inteahepatic biliary stones
5. Coexistence of biliary pancreatitis
6. Severe cholangitis based on Tokyo Guideline 2018
7. Past history of treatment by ERCP
8. Bleeding tendency
9. ASA >=3
10. ECOG PS >=4
11. Severe heart or plumonary disease
12. Pregnant or possibly pregnant women
13. Any disorder that compromised the patient's ability to provide written informed consent and/or comply with the study procedure
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuyoshi Hayashi
Organization Teine Keijinkai Hospital
Division name Center for Gastroenterology
Zip code
Address 1-40, 12-chome, 1-jou, Maeda, Teine-ku, Sapporo 006-8555, Hokkaido, Japan
TEL 011-681-8111
Email thayashi244@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Hayashi
Organization Teine Keijinkai Hospital
Division name Center for Gastroenterology
Zip code
Address 1-40, 12-chome, 1-jou, Maeda, Teine-ku, Sapporo 006-8555, Hokkaido, Japan
TEL 011-681-8111
Homepage URL
Email thayashi244@gmail.com

Sponsor
Institute Center for Gastroenterology, Teine Keijinkai Hospital
Institute
Department

Funding Source
Organization Center for Gastroenterology, Teine Keijinkai Hospital
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
2019 Year 02 Month 18 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 Enrolling by invitation
Date of protocol fixation
2019 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 17 Day
Last modified on
2019 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040897

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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