UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021441 |
|---|---|
| Receipt number | R000024544 |
| Scientific Title | A multicenter prospective study to assess utility and safety of a metal stent with special designed for partial stent-in-stent for obstructive jaundice in patients with unresectable malingant hilar part stenosis. |
| Date of disclosure of the study information | 2016/03/12 |
| Last modified on | 2023/05/14 14:53:59 |
* 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 multicenter prospective study to assess utility and safety of a metal stent with special designed for partial stent-in-stent for obstructive jaundice in patients with unresectable malingant hilar part stenosis.
Acronym
A multicenter prospective study to assess utility and safety of a metal stent with malignant hilar part stenosis.
Scientific Title
A multicenter prospective study to assess utility and safety of a metal stent with special designed for partial stent-in-stent for obstructive jaundice in patients with unresectable malingant hilar part stenosis.
Scientific Title:Acronym
A multicenter prospective study to assess utility and safety of a metal stent with malignant hilar part stenosis.
Region
| Japan |
Condition
Condition
Obstructive jaundice
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the clinical outcome of a new self-expandable metal stent with special desingned partial stent-in-stent for drainage treatment of obstructive jaundice due to unresectable malignant hilar part stenosis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Technical success by partial stent-in stent method
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. patinets with unresectable malignant hilar part stenosis with histological evidence
2. Bismuth classification II, III, IV
3. ECOG(Eastern Cooperative Oncology Group) performance status 0-3
4. Written informed consent
Key exclusion criteria
1. Inpossibility to reach the scope to the second portion or insert the canula to the papilla
2. Inability to expect efficacy of biliary drainage
3. severe failure of the other organs: ASA classification of 3 or more
4. ECOG performance status 4
5. poor prognosis of 3 months or less
6. post-surgical reconstruction of bile duct
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamao |
Organization
Kinki University faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
584-0074
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL
072-366-0221
yamaken_volvo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Yamao |
Organization
Kinki University faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
584-0074
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
TEL
072-366-0221
Homepage URL
yamaken_volvo@yahoo.co.jp
Sponsor or person
Institute
Kinki University faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kinki University faculty of Medicine
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
Institution Review Board in Kindai Universitu
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka, JAPAN
Tel
072-366-0221
zizen@med.kindai.ac.j
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
| 2016 | Year | 03 | Month | 12 | 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
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 30 | Day |
Other
Other related information
Study design: Cohort study
Patients: All consecutive patients with inclusion criteria in February, 2016- December, 2017.
To assess the clinical outcome of a new self-expandable metal stent with special desingned partial stent-in-stent for drainage treatment of obstructive jaundice due to unresectable malignant hilar part stenosis.
Management information
Registered date
| 2016 | Year | 03 | Month | 11 | Day |
Last modified on
| 2023 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024544
