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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037958
Receipt No. R000043253
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.
Date of disclosure of the study information 2019/10/01
Last modified on 2019/09/07

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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