UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057746 |
|---|---|
| Receipt number | R000065992 |
| Scientific Title | A retrospective study of novel tapered-and-flared fully covered self-expandable metal stent placement for unresectable malignant distal biliary obstruction |
| Date of disclosure of the study information | 2025/04/30 |
| Last modified on | 2026/05/18 22:23:03 |
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Basic information
Public title
A retrospective study of novel tapered-and-flared fully covered self-expandable metal stent placement for unresectable malignant distal biliary obstruction
Acronym
A retrospective study of novel tapered-and-flared fully covered self-expandable metal stent placement for unresectable malignant distal biliary obstruction
Scientific Title
A retrospective study of novel tapered-and-flared fully covered self-expandable metal stent placement for unresectable malignant distal biliary obstruction
Scientific Title:Acronym
A retrospective study of novel tapered-and-flared fully covered self-expandable metal stent placement for unresectable malignant distal biliary obstruction
Region
| Japan |
Condition
Condition
unresectable malignant distal biliary obstruction
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of tapered-and-flared fully covered self-expandable metal stent for unresectable malignant distal biliary obstruction
Basic objectives2
Safety,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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent transpapillary placement of a 10 mm tapered-and-flared fully covered self-expandable metal stent for unresectable malignant distal biliary obstruction
Key exclusion criteria
Patients after bilioenteric anastomosis
Patients in whom clinical success is not expected by stent placement
Patients with biliary drainage using multiple stents
Patients with a history of biliary drainage using tapered-and-flared fully covered self-expandable metal stent
Target sample size
40
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, Japan
TEL
0596-28-2171
murabayashitoji@m2.gmobb.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, Japan
TEL
0596-28-2171
Homepage URL
murabayashitoji@m2.gmobb.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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Ise Red Cross Hospital
Address
1-471-2, Funae, Ise, Mie, Japan
Tel
0596-28-2171
jimubu@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
| 2025 | Year | 04 | Month | 30 | Day |
Related information
URL releasing protocol
https://e-ce.org/journal/view.php?doi=10.5946/ce.2025.399
Publication of results
Published
Result
URL related to results and publications
https://e-ce.org/journal/view.php?doi=10.5946/ce.2025.399
Number of participants that the trial has enrolled
40
Results
Technical and clinical success rates were 100% and 98%, respectively. During a median follow-up period of 271 days, recurrent biliary obstruction (RBO) occurred in 10 (26%) patients. The median TRBO was 539 days (95% confidence interval, 389-not reached), and the non-RBO rates at 3, 6, and 12 months were 94%, 71%, and 61%, respectively.Post-endoscopic retrograde cholangiopancreatography pancreatitis occurred in four patients (10%). Non-occlusion cholangitis developed in five (13%) patients.
Results date posted
| 2026 | Year | 05 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 04 | Month | 23 | Day |
Baseline Characteristics
40 patients who underwent transpapillary placement of a tapered and flared fully covered self-expandable metal stent for unresectable malignant distal biliary obstruction between May 2023 and July 2024.
Participant flow
This multicenter retrospective study included 40 patients who underwent transpapillary placement of a tapered and flared fully covered self-expandable metal stent for unresectable malignant distal biliary obstruction between May 2023 and July 2024.
Adverse events
Post-endoscopic retrograde cholangiopancreatography pancreatitis occurred in four patients (10%).
Outcome measures
Technical and clinical success rates were 100% and 98%, respectively. During a median follow-up period of 271 days, recurrent biliary obstruction (RBO) occurred in 10 (26%) patients. The median TRBO was 539 days (95% confidence interval, 389-not reached), and the non-RBO rates at 3, 6, and 12 months were 94%, 71%, and 61%, respectively. During a median follow-up period of 271 days, recurrent biliary obstruction (RBO) occurred in 10 (26%) of the 39 patients who achieved clinical success. Non-occlusion cholangitis developed in five (13%) patients, mostly with tumor-related duodenal stenosis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 10 | Month | 30 | Day |
Other
Other related information
A multicenter retrospective study
Management information
Registered date
| 2025 | Year | 04 | Month | 30 | Day |
Last modified on
| 2026 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065992
