UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Modified Fully Covered Self-expandable Metal Stent vs. Plastic Stent for Preoperative Biliary Drainage in Patients with Resectable Malignant Biliary Obstruction
Title of the study (Brief title)	M-FCSEMS for preoperative biliary drainage
Region	Asia(except Japan)

Condition
Condition	Under IRB
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the superiority of modified FCSEMS (M-FCSEMS) over PS, by comparing the PBD-related adverse events, re-intervention rate, and perioperative adverse events in patients with resectable MBO
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PBD-related adverse events during the interval period up to surgery
Key secondary outcomes	Re-intervention rate requiring additional procedure before surgery and Perioperative adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	During August 2015 - August 2017 ERCP and biliary drainage with BONASTENT M-intraductal 12 or plastic stent performed. Re-intervention was performed for stent exchange or additional procedure when patients developed cholangitis, stent migration, and other adverse events before surgery.
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	-Age between 18 and 80 years -MBO at least 10 mm below the hilar bifurcation -Obstructive jaundice and/or cholangitis -No evidence of distant metastasis or major arterial invasion based on imaging studies
Key exclusion criteria	-MBO on hilum -Previous endoscopic biliary drainage or percutaneous transhepatic biliary drainage -Combined cholecystitis or pancreatitis -Surgically altered anatomy -Not underwent operation due to comorbidity, neoadjuvant chemotherapy, refusal or follow-up loss
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, Gyenggi-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, Gyenggi-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	SoonChunHyang University hospital (Bucheon)

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 31 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2014 Year 01 Month 01 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 05 Month 31 Day

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=R000034497