UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054052 |
|---|---|
| Receipt number | R000061713 |
| Scientific Title | A non-inferiority randomized controlled trial of balloon dilatation alone versus balloon dilatation with stenting for stricture of choledochojejunostomy |
| Date of disclosure of the study information | 2024/04/03 |
| Last modified on | 2024/04/03 16:50:00 |
* 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
A non-inferiority randomized controlled trial of balloon dilatation alone versus balloon dilatation with stenting for stricture of choledochojejunostomy
Acronym
CJ stricture trial
Scientific Title
A non-inferiority randomized controlled trial of balloon dilatation alone versus balloon dilatation with stenting for stricture of choledochojejunostomy
Scientific Title:Acronym
CJ stricture trial
Region
| Japan |
Condition
Condition
CholedochojeJunostomy stricture
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Endoscopic retrograde cholangiopancreatography (ERCP) using double-balloon enteroscopy (DBE) to evaluate cholangitis recurrence-free survival in patients with biliary jejunostomy stricture. ) Verify that manual balloon dilation alone is non-inferior to balloon dilation combined with stent placement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cholangitis recurrence-free survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
For cholangiojejunostomy stenosis, the test treatment group will be treated with balloon dilation alone, and the control treatment group will be treated with a combination of balloon dilation and stent placement.
Interventions/Control_2
For cholangiojejunostomy stenosis, the test treatment group will be treated with balloon dilation alone, and the control treatment group will be treated with a combination of balloon dilation and stent placement.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Have a history of treatment for bile duct jejunostomy.
2) Elevated hepatobiliary enzymes within 90 days before enrollment. The above was approved.
3) Intrahepatic bile duct dilatation is found on imaging tests.
4) No serious renal disorder (latest serum creatinine value less than 2.0 mg/dl and eGFR 30 ml/min/1.73 m2 or more within 28 days before registration).
5) Do not have severe diabetes (no concurrent diabetes or latest HbA1c less than 10% within 28 days before registration).
6) Be at least 18 years old at the time of consent.
7) Written consent has been obtained from the individual to participate in the research.
Key exclusion criteria
1) Have a history of hypersensitivity to iodine or iodine contrast media.
2) Have poorly controlled hyperthyroidism (thyroid function is not stable despite untreated status or treatment).
3) Have a serious heart disorder (acute myocardial infarction, intractable arrhythmia, or other severe heart disease)
4) Have serious lung disease (with symptoms such as hypoxemia and difficulty breathing).
5) Have active multiple cancers (synchronous multiple cancers and metachronous multiple cancers with a disease-free period of 5 years or less). However, this does not include carcinoma in situ, which is considered to be curable with treatment.
6) Concomitant disseminated intravascular coagulation (meeting the diagnostic criteria of the Japanese Society of Thrombosis and Haemostasis DIC diagnostic criteria 2017 edition [12]).
7) Having biliary stricture due to malignant tumor.
8) I am pregnant.
9) A bile duct jejunostomy other than an anastomosis is confirmed by imaging test (ultrasound, CT, or MRI) or ERCP.
Target sample size
112
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiko |
| Middle name | |
| Last name | Fukuba |
Organization
Shimane University
Division name
Internal medicine II
Zip code
6938501
Address
89-1,Enya-cho, Izumo, Shimane,Japan
TEL
0853-23-2111
nfukuba@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | NOBUHIKO |
| Middle name | |
| Last name | FUKUBA |
Organization
Shimane University
Division name
Internal medicine II
Zip code
693-8501
Address
89-1,Enya-cho, Izumo, Shimane,Japan
TEL
0853-23-2111
Homepage URL
nfukuba@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Non
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
Medical Research Ethics Committee,Shimane University Faculty of Medicine
Address
89-1,Enya-cho, Izumo, Shimane,Japan
Tel
0853-23-2111
kenkyu@med.shimane-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
| 2024 | Year | 04 | Month | 03 | 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
| 2024 | Year | 03 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2024 | Year | 04 | Month | 03 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061713
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
