UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019271 |
|---|---|
| Receipt number | R000022266 |
| Scientific Title | Efficacy of metallic stent for benign biliary stricture. |
| Date of disclosure of the study information | 2015/10/07 |
| Last modified on | 2022/04/29 16:18:19 |
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Basic information
Public title
Efficacy of metallic stent for benign biliary stricture.
Acronym
Efficacy of metallic stent for benign biliary stricture.
Scientific Title
Efficacy of metallic stent for benign biliary stricture.
Scientific Title:Acronym
Efficacy of metallic stent for benign biliary stricture.
Region
| Japan |
Condition
Condition
Benign biliary stricture
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the long-term efficacy and safty of matallic stent for benign biliary stricture requiring drainage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
time of stent patency
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
biliary metallic stent
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) Patients' age of more than 20 years-old.
2) Patients having biliary stricture requiring drainage caused by benign diseases as follow; chronic pancreatitis, autoimmune pancreatitis, inflammatory stricture, stricture of anastomosis after liver or bile duct resection including liver transplantation, biliary injury caused by surgical procedure, sclerosing cholangitis and lower biliary stricture caused by duodenal papillitis.
3) Patients having cholangitis, obstructive jaundice and liver dysfunction caused by benign biliary stricture.
4) Written informed consent is obtained from patient before the study.
Key exclusion criteria
1) Patients' age of less than 20 years-old.
2)Written informed consent is not obtained from patient before the study.
3) Patients who are judged inappropriate by chief (responsive) medical examiner.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takamitsu |
| Middle name | |
| Last name | Sato |
Organization
Yokohama city university hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.
TEL
+81-45-787-2640
tasatou-ykh@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takamitsu |
| Middle name | |
| Last name | Sato |
Organization
Yokohama city university hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.
TEL
+81-45-787-2640
Homepage URL
tasatou-ykh@umin.ac.jp
Sponsor or person
Institute
Yokohama city university hospital, Department of Gastroenterology and Hepatology.
Institute
Department
Personal name
Funding Source
Organization
Yokohama city university 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
Yokohama city university hospital
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, Japan.
Tel
045-787-2714
chiken@yokohama-cu.ac.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
| 2015 | Year | 10 | Month | 07 | 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
| 2015 | Year | 09 | Month | 17 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 07 | Day |
Last modified on
| 2022 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022266
