UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013130 |
|---|---|
| Receipt number | R000015312 |
| Scientific Title | A pilot study to evaluate safety and efficacy of electrohydraulic lithotripsy for difficult biliary and pancreatic stones |
| Date of disclosure of the study information | 2014/02/12 |
| Last modified on | 2022/01/26 16:34:27 |
* 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
A pilot study to evaluate safety and efficacy of electrohydraulic lithotripsy for difficult biliary and pancreatic stones
Acronym
EHL for biliary/pancreatic stones
Scientific Title
A pilot study to evaluate safety and efficacy of electrohydraulic lithotripsy for difficult biliary and pancreatic stones
Scientific Title:Acronym
EHL for biliary/pancreatic stones
Region
| Japan |
Condition
Condition
Biliary and pancreatic stones
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of electrohydraulic lithotripsy for biliary/pancreatic stones
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete removal of biliary and pancreatic stones
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
| Device,equipment |
Interventions/Control_1
EHL generator and probe
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. Patients with biliary and pancreatic stones diagnosed using ultrasonography, endoscopic ultrasonography, CT or MRCP.
2. Biliary and pancreatic stones which can not be removed by endoscopic mechanical lithotripsy and extracorporeal shock-wave lithotripsy
3. 20 years or older
4. Patients who gave informed consent
Key exclusion criteria
1. Patients with severe cholangitis
2. Patients with acute pancreatitis
3. In case of peroral cholangioscopy with EHL planned, patients who are unfit for peroral endoscopy are excluded.
4. Patients whose antithrombotic agents can not be discontinued or who have uncontrolled coagulopathy
5. Patients with pregnancy or suspected pregnanacy
6. Patients with a pacemaker
7. Patients who are considered ineligible by a attending physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Isayama |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
isayama-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Hamada |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
Homepage URL
hamada-tky@umin.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
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
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
| 2014 | Year | 02 | Month | 12 | 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
| 2014 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2014 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 10 | Day |
Last modified on
| 2022 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015312
