UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010130 |
|---|---|
| Receipt number | R000011866 |
| Scientific Title | The efficacy of a modified fully covered self-expandable metal stent for a benign pancreatic duct and biliary stricture in chronic pancreatitis. |
| Date of disclosure of the study information | 2013/02/28 |
| Last modified on | 2014/03/04 15:04:13 |
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Basic information
Public title
The efficacy of a modified fully covered self-expandable metal stent for a benign pancreatic duct and biliary stricture in chronic pancreatitis.
Acronym
The use experience of fully covered self-expandable metal stent for a benign stricture.
Scientific Title
The efficacy of a modified fully covered self-expandable metal stent for a benign pancreatic duct and biliary stricture in chronic pancreatitis.
Scientific Title:Acronym
The use experience of fully covered self-expandable metal stent for a benign stricture.
Region
| Japan |
Condition
Condition
A benign pancreatic duct and biliary stricture in chronic pancreatitis.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of a modified fully covered self-expandable metal stent
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Resolution rate of the biliary-pancreatic stricture and Recurrance rate
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
All patients had previously undergone endoscopic sphincterotomy, then metallic stent placement.
The stricture was dilated before metallic stent placement.
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 Age 18 years of age and older.
2 All patients provided written informed
consent.
3 The case which has dilatation in the
distal segment from stricture.
4 The case which a stricture remains
after endoscopic treatment.
5 The case which has caused an acute
cholangitis and acute pancreatitis.
Key exclusion criteria
1 The case which is state of
pancreatitis and cholangitis.
2 A stricture of pancreatic tail.
3 The case of the pancreatic cancer
and cholangiocarcinoma.
4 A tendency of bleeding.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigefumi Omuta |
Organization
Toho University Ohashi Medical center
Division name
Div. of Gastroenterology, Dept. of Internal Medicine
Zip code
Address
2-17-6 Ohashi, Meguro-ku Tokyo
TEL
03-3468-1251
muta@oha.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigefumi Omuta |
Organization
Toho University Ohashi Medical center
Division name
Div. of Gastroenterology, Dept. of Internal Medicine
Zip code
Address
Meguro-ku Ohashi 2-17-6
TEL
03-3468-1251
Homepage URL
muta@oha.toho-u.ac.jp
Sponsor or person
Institute
Div. of Gastroenterology, Dept. of Internal Medicine
Toho University Ohashi Medical center
Institute
Department
Personal name
Funding Source
Organization
Div. of Gastroenterology, Dept. of Internal Medicine
Toho University Ohashi Medical center
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
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
| 2013 | Year | 02 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 27 | Day |
Last modified on
| 2014 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011866
