UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030201
Receipt No. R000034500
Scientific Title The Usefulness of Newly Modified Non-flared Fully Covered Metal Stent of 12 mm in diameter Comparing with Conventional Stent for Periampullary Malignant Biliary Strictures
Date of disclosure of the study information 2017/12/31
Last modified on 2017/11/30

* 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 Usefulness of Newly Modified Non-flared Fully Covered Metal Stent of 12 mm in diameter Comparing with Conventional Stent for Periampullary Malignant Biliary Strictures
Acronym M-FCSEMS in periampullary malignant biliary stricture
Scientific Title The Usefulness of Newly Modified Non-flared Fully Covered Metal Stent of 12 mm in diameter Comparing with Conventional Stent for Periampullary Malignant Biliary Strictures
Scientific Title:Acronym M-FCSEMS in periampullary malignant biliary stricture
Region
Asia(except Japan)

Condition
Condition under IRB
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of newly modified non-flared FCSEMS (M-FCSEMS) having 12mm in diameter to minimized stent migration compared with the conventional FCSEMS in patients with periampullary MBS
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stent migration rate in periampullary malignant biliary stricture
Key secondary outcomes -Technical success rate
-Clinical success rate
-Other adverse events
-Stent occlusion and re-intervention rate
-Stent patency

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 ERCP with biliary drainage of newly modified non-flared FCSEMS(BONASTENT M-intraductal 12)
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Age at least 18 years
2)Periampullary cancer; ampulla of Vater cancer, distal CBD cancer, pancreatic head cancer
3)Clinical symptoms of biliary obstruction with obstructive jaundice and/or cholangitis
Key exclusion criteria 1)Surgically altered anatomy
2)Bleeding tendency (INR > 1.5 or platelet count < 50,000/mm3)
3)Contraindications for ERCP
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jong Ho Moon
Organization SoonChunHyang University School of Medicine
Division name Digestive Disease Center and Research Institute
Zip code
Address 170 Jomaru-ro, Bucheon-si, Gyeonggi-do, Korea
TEL +821087153543
Email jhmoon@schmc.ac.kr

Public contact
Name of contact person
1st name
Middle name
Last name Hyun Woo Lee
Organization SoonChunHyang University School of Medicine
Division name Digestive Disease Center and Research Institute
Zip code
Address 170 Jomaru-ro, Bucheon-si, Gyeonggi-do, Korea
TEL +821080235271
Homepage URL
Email imlhw@schmc.ac.kr

Sponsor
Institute SoonChunHyang University School of Medicine
Digestive Disease Center and Research Institute
Institute
Department

Funding Source
Organization SoonChunHyang University School of Medicine
Digestive Disease Center and Research Institute
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
2017 Year 12 Month 31 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 No longer recruiting
Date of protocol fixation
2014 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 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
2017 Year 11 Month 30 Day
Last modified on
2017 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034500

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.