UMIN-CTR Clinical Trial

Basic information
Public title	A prospective randomized control trial comparing newly designed 7mm double-bare metal stent and 7mm single-bare metal stent in patient with hilar malignant biliary strictures.
Acronym	A prospective randomized control trial comparing double-bare metal stent and single-bare metal stent in patient with hilar malignant biliary strictures.
Scientific Title	A prospective randomized control trial comparing newly designed 7mm double-bare metal stent and 7mm single-bare metal stent in patient with hilar malignant biliary strictures.
Scientific Title:Acronym	A prospective randomized control trial comparing double-bare metal stent and single-bare metal stent in patient with hilar malignant biliary strictures.
Region	Japan

Condition
Condition	Hilar malignant biliary obstruction
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and sefety of double bare metal stent for patient with unresectable malignant hilar biliary obstruction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time to Recurrent Biliary Obstruction
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Placement of 7mm double bare metal stent by side by side method.
Interventions/Control_2	Placement of 7mm single bare metal stent by side by side method.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients diagnosed as malignant hilar biliary obstruction of Bismuth classification II or higher by histopathology or diagnostic imaging such as CT and MRI 2) Patients with obstructive jaundice (Total billirubin> 2mg / dL) due to malignant hilar biliary obstruction at the first drainage 3) Patients who are over 20 years old when obtaining consent 4) Patients who have been diagnosed as clinically non-resectable 5) Patients who are expected to survive more than 3 months 6) Patients who have obtained their written informed consent to participate in the study
Key exclusion criteria	1) Patients who cannot receive endoscopic treatment due to general condition, jaw, oral cavity and digestive tract condition 2) Patients who have more than ASA Classification class 4(with severe life-threatening systemic disease) poor general condition or severe complications (severe congestive heart failure, severe coronary failure) 3) Patients after reconstruction of upper gastrointestinal tract other than Billroth-I reconstruction 4) Patients after excision of the duodenal papilla, after papilloplasty, and after surgical biliary anastomosis 5) Patients who are considering radical resection, radiation therapy, particle beam therapy, photodynamic therapy, high-intensity focused ultrasound 6) Patients whose periodic replacement of PS is considered desirable 7) Patients after biliary stent placement that cannot be removed 8) Patients whose endoscopic drainage is considered to be ineffective because of severely severe biliary branching due to huge intrahepatic cholangiocarcinoma or extensive cholangiocarcinoma 9) Patients who judge that uncovered MS placement should be avoided when tumor bleeding is severe, or when it is composed of a luminal growth type papillary tumor such as IPNB. 10) Patients with uncontrolled active infection other than acute cholangitis 11) Patients with primary sclerosing cholangitis, IgG4-related cholangitis, primary biliary cholangitis 12) Patients who have difficulty in determining the yellowing effect due to severe cirrhosis 13) Patients who have high total billirubin due to hemolytic disease and may not have obstructive jaundice 14) Patients with a history of allergy to biliary contrast media and severe allergies to angiographic media 15) Patients who are pregnant or may be pregnant 16) Patients whose follow-up is considered impossible at the study participating facility or related facilities that can be in close contact
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Irisawa
Organization	Dokkyo Medical University
Division name	Department of gastroenterology
Zip code	321-0293
Address	880, Kitakobayashi, Mibu, Shimotsuma, Tochigi
TEL	0282-86-1111
Email	irisawa@dokkyomed.ac.jp

Public contact
Name of contact person	1st name Kouhei Middle name Last name Tsuchida
Organization	Dokkyo Medical University
Division name	Department of gastroenterology
Zip code	321-0293
Address	880, Kitakobayashi, Mibu, Shimotsuma, Tochigi
TEL	0282-86-1111
Homepage URL
Email	tsuchida@dokkyomed.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

Funding Source
Organization	Non
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	Dokkyo Medical University
Address	880, Kitakobayashi, Mibu, Shimotsuma, Tochigi
Tel	0282-86-1111
Email	tsuchida@dokkyomed.ac.jp

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	2019 Year 10 Month 01 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	Preinitiation
Date of protocol fixation	2019 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date	2019 Year 10 Month 01 Day
Last follow-up date	2022 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 07 Day
Last modified on	2019 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043253