UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055977 |
|---|---|
| Receipt number | R000063971 |
| Scientific Title | A prospective study of fully covered self-expandable metal stent placement for unresectable malignant distal biliary obstruction to find the optimal stent |
| Date of disclosure of the study information | 2024/10/29 |
| Last modified on | 2026/02/02 22:04:35 |
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Basic information
Public title
A prospective study of metal stent placement for unresectable malignant distal biliary obstruction
Acronym
A prospective study of metal stent placement for unresectable malignant distal biliary obstruction
Scientific Title
A prospective study of fully covered self-expandable metal stent placement for unresectable malignant distal biliary obstruction to find the optimal stent
Scientific Title:Acronym
A prospective study of fully covered self-expandable metal stent placement for unresectable malignant distal biliary obstruction to find the optimal stent
Region
| Japan |
Condition
Condition
unresectable distal biliary obstruction due to pancreatobiliary cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to prospectively evaluate the efficacy of tapered-and-flared fully covered self-expandable metal stent for unresectable malignant distal biliary obstruction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
time to recurrent biliary obstruction
Key secondary outcomes
Causes of recurrence of biliary obstruction (RBO)
Technical success rate
Clinical success rate
Rate of early adverse events
Rate of late adverse events other than RBO
Survival period
Technical success rate of reintervention in cases of RBO
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who underwent transpapillary placement of a 10 mm FCSEMS for malignant distal biliary obstruction due to pancreatobiliary cancer
2) Patients scheduled to undergo non-resection
3) Patients whose life prognosis are expected more than 3 months
Key exclusion criteria
1) Patients with postoperative reconstruction of the upper gastrointestinal tract
2) Patients after bilioenteric anastomosis
3) Patients in whom clinical success is not expected by stent placement
4) Patients with a history of biliary drainage using metal stent
5) Pregnant patients
6) Patients who ultimately underwent surgical resection for the malignant distal biliary obstruction
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Toji |
| Middle name | |
| Last name | Murabayashi |
Organization
Ise Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
516-8512
Address
1-471-2, Funae, Ise, Mie, 516-8512, Japan
TEL
0596-28-2171
t-murabayashi@ise.jrc.or.jp
Public contact
Name of contact person
| 1st name | Toji |
| Middle name | |
| Last name | Murabayashi |
Organization
Ise Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
516-8512
Address
1-471-2, Funae, Ise, Mie, 516-8512, Japan
TEL
0596-28-2171
Homepage URL
t-murabayashi@ise.jrc.or.jp
Sponsor or person
Institute
Ise Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
None.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shizuoka General Hospital Shizuoka, Yokkaichi Municipal Hospital, Suzuka General Hospital, Mie Chuo Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Ise Red Cross Hospital
Address
1-471-2, Funae, Ise, Mie, 516-8512, Japan
Tel
0596-28-2171
jimbu@ise.jrc.or.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 | 10 | Month | 29 | 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
| 2024 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
multicenter study
Management information
Registered date
| 2024 | Year | 10 | Month | 29 | Day |
Last modified on
| 2026 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063971
