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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023415
Receipt No. R000026906
Scientific Title A prospective study: the efficacy of balloon equiped sphincterotome for endoscopic therapy of large common bile duct stones
Date of disclosure of the study information 2016/09/01
Last modified on 2016/07/31

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Basic information
Public title A prospective study: the efficacy of balloon equiped sphincterotome for endoscopic therapy of large common bile duct stones
Acronym The efficacy of ballon equiped sphincterotome for large common bile duct stones
Scientific Title A prospective study: the efficacy of balloon equiped sphincterotome for endoscopic therapy of large common bile duct stones
Scientific Title:Acronym The efficacy of ballon equiped sphincterotome for large common bile duct stones
Region
Japan

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

Objectives
Narrative objectives1 To verify the efficacy of balloon equiped EST catheter for endoscopic therapy of large common bile duct stones
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Procedure time (Total time, cannulation time, stone removal time)
Key secondary outcomes 1. Complete stone removal rate
2. Complete procedure rate (complete stone removal rate + biriary stenting)
3. No of mechenical lithotripsy
4. patients background
5. Safety
6. Improvement of hepatobiliary laboratory data

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 Maneuver
Interventions/Control_1 Olympus Stone Master V
Interventions/Control_2 Olympus Clever Cut
Boston Scientific CRE wire guided dilatation 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 Patients whose shorter diameter of common bile duct stones is larger than 10mm.
Key exclusion criteria 1. Patients younger than 20 years old
2. Patients who have been performed endoscopic sphincterotomy.
3. Patients whose stones cannot be removed in first session because of serious cholangitis.
4. Patients who were difficult to perform endoscopic therapy because of gastrointestinal obstruction or others.
5. Patients without consent.
6. Patients with histories of abdominal surgeries.
7. Patients for whom endoscopic sphincterotomy is difficult with high risk of bleeding.
8. Patients whose shorter diameter of common bile duct stones were longer than diameter of common bile duct.
Target sample size 84

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiromasa Ohira
Organization Fukushima Medical University
Division name Gastrotenterology and Rheumatology
Zip code
Address 1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL 024-547-1202
Email h-ohira@fmu.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Mitsuru Sugimoto
Organization Fukushima Medical University
Division name Gastrotenterology and Rheumatology
Zip code
Address 1 Hikarigaoka, Fukushima City, Fukushima Prefecture
TEL 024-547-1202
Homepage URL
Email kita335@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Fukuhsima Medical University
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
2016 Year 09 Month 01 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 Preinitiation
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 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
2016 Year 07 Month 31 Day
Last modified on
2016 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026906

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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