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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024440
Receipt No. R000028134
Scientific Title Efficacy for combination therapy using double-balloon enteroscope and ultraslim endoscope for the treatment of hepatolithiasis in patients with hepaticojejunostomy
Date of disclosure of the study information 2016/11/01
Last modified on 2016/10/17

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Basic information
Public title Efficacy for combination therapy using double-balloon enteroscope and ultraslim endoscope for the treatment of hepatolithiasis in patients with hepaticojejunostomy
Acronym Efficacy for endoscopic combination therapy for hepatolithiasis
Scientific Title Efficacy for combination therapy using double-balloon enteroscope and ultraslim endoscope for the treatment of hepatolithiasis in patients with hepaticojejunostomy
Scientific Title:Acronym Efficacy for endoscopic combination therapy for hepatolithiasis
Region
Japan

Condition
Condition Hepatolithiasis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy for combination therapy using double-balloon enteroscope and ultraslim endoscope for the treatment of hepatolithiasis in patients with hepaticojejunostomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection rate of residual stone (After removal of hepatolithiasis using DBE, an ultraslim endoscope is directly inserted into the IHBD. The rate of detection of residual stones by ultraslim endoscope)
Key secondary outcomes 1. Success rate of direct cholangioscopy using ultraslim endoscope
2. Success rate of residual stone removal
3. Examination time
4. Adverse event
5. Rate of recurrence stone.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. The patients with intrahepatic bile duct (IHBD) stones who underwent bowel reconstruction with hepaticojejunostomy(HJ)
2. Patients with informed consent.
Key exclusion criteria 1.Patients with performance status 4
2.Patients with severe complications to other organs
3.Bowel reconstruction with Rouen-Y
4.Age<20
5.Patients without informed consent
6.MRI cannot be taken
7.Patients who are judged inappropriate by chief medical examiner
Target sample size 44

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironari Kato
Organization Okayama University Hospital
Division name Department of Gastroenterology & Hepatology
Zip code
Address 2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
TEL 086-235-7219
Email drkatocha@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyuki Matsumoto
Organization Okayama University Hospital
Division name Department of Gastroenterology & Hepatology
Zip code
Address 2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
TEL 086-235-7219
Homepage URL
Email matsumotokazuyuki0227@yahoo.co.jp

Sponsor
Institute Okayama University Hospital
Institute
Department

Funding Source
Organization none
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 11 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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 07 Day
Date of IRB
Anticipated trial start date
2016 Year 11 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 Research design: prospective cohort study
Recruiting methods of objects: all the patients who conform to the criteria visiting to Okayama University Hospital between Nov 2016 to Nov 2021
Measuring item: Primary and secondary endopoints. Follow up methods for recurrence stone include laboratory data and image examinations(MRCP) were evaluated at 6 and 12 months after treatment.

Management information
Registered date
2016 Year 10 Month 17 Day
Last modified on
2016 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028134

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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