UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035904 |
|---|---|
| Receipt number | 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 14:17:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
thayashi244@gmail.com
Sponsor or person
Institute
Center for Gastroenterology, Teine Keijinkai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
