UMIN-CTR Clinical Trial

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
Email	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
Email	hamada-tky@umin.ac.jp

Sponsor
Institute	Graduate School of Medicine, The University of Tokyo
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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015312