UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015093 |
|---|---|
| Receipt number | R000017551 |
| Scientific Title | Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial- |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2020/01/21 12:31:11 |
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Basic information
Public title
Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-
Acronym
Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-
Scientific Title
Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-
Scientific Title:Acronym
Usefulness and safety in uncovered metallic stent and the covered metallic stent insertion for distal biliary tract obstruction in the unresectable malignancy. -multi-center prospective randomized trial-
Region
| Japan |
Condition
Condition
unresectable distal biliary obstruction
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of metallic stent of uncovered metallic stent and covered metallic stent for distal biliary tract obstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
stent patency
obstruction rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Uncovered metallic stent
Interventions/Control_2
Covered metallic stent
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. Having lower part biliary tract stenosis in the unresectable malignancy; an adaptation patient of endoscopic retrograde bile duct pancreatic duct contrasting (ERCP).
2. It can be indicated the art of endoscopic duodenal nipple incision and drainage, and an agreement is provided when it enforces it again.
3. When I perform a pathological search and get a malignant definitive diagnosis, or a malignancy is diagnosed by an image and hematologic inspection clinically even if I perform a pathological search when a malignant diagnosis is difficult.
4.Performance status is a patient of 0-2.
5.Having chemoradiation treatment combination or not does not matter.
6.Age is a patient 20 years or older at the agreement acquisition.
7.A document agreement by the free will of the patient person is provided in the one which understands enough it after having received enough explanation on participating of the final examination case 8 within 30th from the first drainage.
9.I am limited to a patient admitted to other Houses after hospitalization or treatment.
Key exclusion criteria
1.The patient who has bile duct stenosis in the liver from a hepatic portal region.
2.A state is extremely bad from head to foot.
3.) not to include the case that removed duodenal confinement by patient (Stent or the operation that duodenal 3rd portion blocked up.
4. The patient who cannot agree to endoscopic retrograde bile duct pancreatic duct contrasting (ERCP) or endoscopic treatment (endoscopic nipple incision, art of drainage).
5.The patient with the allergy to metal.
6.A patient with a history of the custody of the past metallic stent.
7.A patient considered to be below 30 days in convalescence.
Target sample size
98
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Tsuyuguchi |
Organization
Chiba University
Division name
Gastroenterology
Zip code
Address
Inohana 1-8-1, Chuou-ku, Chiba City, 260-8670, Japan.
TEL
81-43-2262083
sakai4754@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Sakai |
Organization
Chiba Univeresity
Division name
Gastroenterology
Zip code
Address
Inohana 1-8-1, Chuou-ku, Chiba City, 260-8670, Japan.
TEL
81-43-2262083
Homepage URL
sakai4754@yahoo.co.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Boston Scientific Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2014 | Year | 10 | Month | 01 | 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
| 2014 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 09 | Day |
Last modified on
| 2020 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017551
