UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010130
Receipt No. 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

* 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 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
Email 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
Email muta@oha.toho-u.ac.jp

Sponsor
Institute Div. of Gastroenterology, Dept. of Internal Medicine
Toho University Ohashi Medical center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011866

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.