UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Jong Ho Moon
Organization	SoonChunHyang University School of Medicine
Division name	Digestive Disease Center and Research Institute
Address	170 Jomaru-ro, Bucheon-si, Gyeonggi-do, Korea
TEL	+821087153543
Email	jhmoon@schmc.ac.kr

Public contact
Name of contact person	Hyun Woo Lee
Organization	SoonChunHyang University School of Medicine
Division name	Digestive Disease Center and Research Institute
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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