UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031034 |
|---|---|
| Receipt number | R000035429 |
| Scientific Title | The study of changes in values of dispersion slope at pre and post biliary drainage in patients with obstructive jaundice |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2023/05/29 01:25:33 |
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Basic information
Public title
The study of changes in values of dispersion slope at pre and post biliary drainage in patients with obstructive jaundice
Acronym
The study of values of dispersion slope before and after biliary drainage
Scientific Title
The study of changes in values of dispersion slope at pre and post biliary drainage in patients with obstructive jaundice
Scientific Title:Acronym
The study of values of dispersion slope before and after biliary drainage
Region
| Japan |
Condition
Condition
Patients with obstructive jaundice scheduled for biliary drainage
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether obstructive jaundice is involved in liver viscosity or not by measurement of dispersion slope values in dispersion imaging before and after biliary drainage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of dispersion slope values before and after biliary drainage
Key secondary outcomes
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) Age =or >20
(2) Obstructive jaundice scheduled for biliary drainage
(3) Providing written informed consent
Key exclusion criteria
(1) Patients who have chronic hepatic disease
(2) Patients who have diffuse liver tumors by imaging test
(3) Patients who have acute cholangitis
(4) Patients who are not expected to be improved regarding jaundice
(5) Evanescent jaundice
(6) Patients who cannot undergo the measurement by abdominal ultrasonography
(7) Pregnancy or suspected pregnancy
(8) Difficult measurement by the shear wave elastography
(9) Patients who was judged inappropriate by a principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
060-8648
Address
North 14, West 5, Kita-ku, Sapporo
TEL
011-716-1161
mkuwatan@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Sugiura |
Organization
Hokkaido University Faculty of Medicine and Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8638
Address
North 15, West 7, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
rsugiura-hok@umin.ac.jp
Sponsor or person
Institute
Hokkaido 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
Institutional Review Board of Hokkaido University Hospital
Address
North 14, West 5, Kita-ku, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2018 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://journals.lww.com/ultrasound-quarterly/Abstract/9900/Significance_of_Shear_Wave_Dispersion_Sl
Publication of results
Published
Result
URL related to results and publications
https://journals.lww.com/ultrasound-quarterly/Abstract/9900/Significance_of_Shear_Wave_Dispersion_Sl
Number of participants that the trial has enrolled
22
Results
The mean +/- SD values of shear wave dispersion measured at day 0, day 2, and day 7 were 15.3 +/- 2.7, 14.2 +/- 3.3, and 13.3 +/- 2.4 m/s/kHz, respectively. The shear wave dispersion values decreased significantly over time after biliary drainage.
Liver elasticity levels and serum hepatobiliary enzymes were decreased significantly over time after biliary drainage.
The correlations between shear wave dispersion and liver elasticity values were strong (r = 0.91, P < 0.01).
Results date posted
| 2023 | Year | 05 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with obstructive jaundice (serum total bilirubin with levels >=2mg/dL) who planned to undergo biliary drainage
Participant flow
Patients with obstructive jaundice (serum total bilirubin with levels >=2mg/dL) who planned to undergo biliary drainage were registered. All patients provided written informed consent.
Adverse events
None.
Outcome measures
The primary outcome was the changes of shear wave dispersion values measured before versus after biliary drainage. The secondary outcomes were the changes of liver shear wave elasticity values and serum hepatobiliary enzymes before versus after biliary drainage, and the coefficients of correlation among the shear wave dispersion value, shear wave elasticity value, and serum hepatobiliary enzymes.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 02 | 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
None
Management information
Registered date
| 2018 | Year | 01 | Month | 28 | Day |
Last modified on
| 2023 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035429
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