UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048405 |
|---|---|
| Receipt number | R000055153 |
| Scientific Title | Stent removal and fistula dilation of EUS-CDS |
| Date of disclosure of the study information | 2022/07/19 |
| Last modified on | 2024/07/19 15:57:20 |
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Basic information
Public title
Stent removal and fistula dilation of EUS-CDS
Acronym
Stent removal and fistula dilation of EUS-CDS
Scientific Title
Stent removal and fistula dilation of EUS-CDS
Scientific Title:Acronym
Stent removal and fistula dilation of EUS-CDS
Region
| Japan |
Condition
Condition
Malignant distal bile duct stenosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of stent removal and fistula dilation after EUS-CDS
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fistula patency
Key secondary outcomes
Clinical course after fistula obstruction
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
EUS-CDS
Stent removal and fistula dilation of EUS-CDS
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. Cases requiring EUS-CDS for jaundice, hepatic dysfunction, and acute cholangitis due to malignant distal bile duct stenosis.
2. Cases in which the age at the time of obtaining consent is 20 years or older.
3. Cases for which informed consent has been obtained from the patient.
Key exclusion criteria
1. Difficult cases of EUS-CDS due to ascites or tumor invasion
2. Cases of poor general condition at the time of stent removal
3. Cases of fistula invasion at the time of stent removal
4.Cases of intrahepatic bile duct stenosis at the time of stent removal
5. Cases that the physician decides inappropriate for this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Hara |
Organization
Aichi Cancer Center Hospital
Division name
Gastroenterology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL
0527626111
khara@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Okuno |
Organization
Aichi Cancer Center Hospital
Division name
Gastroenterology
Zip code
464-8681
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
TEL
0527626111
Homepage URL
nokuno@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi Cancer Center Hospital
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
Aichi Cancer Center
Address
1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi 464-8681, Japan
Tel
0527626111
irb-jimu@aichi-cc.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-0-086
Org. issuing International ID_1
Aichi Cancer Center Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 19 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 19 | Day |
Last modified on
| 2024 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055153
