UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024440 |
|---|---|
| Receipt number | 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 | 2024/01/22 22:59:58 |
* 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
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 | Hironari |
| Middle name | |
| Last name | Kato |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology & Hepatology
Zip code
7008558
Address
2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
drkatocha@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Matsumoto |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology & Hepatology
Zip code
7008558
Address
2-5-1Shikata-cho,Kita-ku Okayama-city Okayama
TEL
086-235-7219
Homepage URL
matsumotokazuyuki0227@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
Okayama university Hospita,lEthics Committee
Address
2-5-1, shikata-cho, kita-ku, okayama city, okayama
Tel
086-235-7219
mae6605@adm.okayama-u.ac.jp
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
44
Results
PDCS was successful in 39/44 patients(89%),among whom residual stones were detected in 16(41%) (95%CI 28-54%).Stone removal was successful in 15(94%) patients and median procedure time was 16(IQR 10-26)min. The rate of procedure related adverse events was 7%(3/44), all of which improved with conservative treatment. During median follow up of 2.1years (IQR 1.4-3.3), the overall probability of recurrence free status at 1, 2, and 3 years was 100%, 92%, and 86%, respectively.
Results date posted
| 2024 | Year | 01 | Month | 22 | Day |
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
| 2016 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 30 | Day |
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 2022
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
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028134
