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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029100
Receipt No. R000033285
Scientific Title A multicenter prospective randomized controlled trial of pass through biliary stricture using a novel, flexible-tip, torquable, angled tip guidewire
Date of disclosure of the study information 2017/09/12
Last modified on 2018/10/26

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Basic information
Public title A multicenter prospective randomized controlled trial of pass through biliary stricture using a novel, flexible-tip, torquable, angled tip guidewire
Acronym TORQUE GW study
Scientific Title A multicenter prospective randomized controlled trial of pass through biliary stricture using a novel, flexible-tip, torquable, angled tip guidewire
Scientific Title:Acronym TORQUE GW study
Region
Japan

Condition
Condition perihilar biliary stricture
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of the new 0.025-inch angled type and straight type guidewire upon performing endoscopic biliary drainage (EBD) for perihilar biliary stricture
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Success rate of each angled type and straight type guidewire passing perihilar biliary stricture within 5 minutes.
Key secondary outcomes 1) Benign or malignancy of the underlying disease
2) Methiods of selective bile duct canulation
3) Required time for selective bile duct canulation
4) Required time for passing the stricture
5) Required number of guidewires for achieving requested bile duct canulation
6) Adverse event
7) Stricture length and type (Bismuth classification)
8) Total procedure time
9) All of performed procedures
10) Catheters and guidewires used in cases of failure (types, numbers).

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Use of angled type guidewire for passing biliary stricture.
Interventions/Control_2 Use of straight type guidewire for passing biliary stricture
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
100 years-old >=
Gender Male and Female
Key inclusion criteria 1) Those indicated perihilar biliary stricture
by imaging modlities inspite of benignity and
malignanc
2) Age of 20 years or more at the time of informed consent.
3) Patients obtained informed consent on their
will.
Key exclusion criteria 1) Performance Status 4
2) Having severe comorbidity (American Society of Anesthesiologists (ASA) classification
3 or more)
3) Unable to stop anti-platelet and anti-coagulant therapy
4) Pregnant or suispicious for pregnancy
5) History of endoscopic biliary drainage
6) Stricture in distal bile duct or intrahepatic bile duct.
7) Bile duct obstruction by stones
8) Scheduled for percutaneous transhepatic o
r endoscopic ultrasound guided rendezvous technique
9) Difficulty in endoscopic biliary approach
due to such as gastrectomy (except for Billroth I reconstruction)
10) Difficulty to insert endoscopy due to apparent gastrointestinal obstruction
11) PT-INR of 2.0 or more
12) Those judged inappropriate by participating doctors
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Kawakami
Organization University of Miyazaki
Division name Department of Gastroenterology and Hepatology
Zip code
Address 5200 Kihara, Kiyotake-cho, Miyazaki city, Miyazaki
TEL 0985-85-9797
Email hiropon@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimasa Kubota
Organization University of Miyazaki
Division name Department of Gastroenterology and Hepatology
Zip code
Address 5200 Kihara, Kiyotake-cho, Miyazaki city, Miyazaki
TEL 0985-85-9797
Homepage URL
Email y_kubota@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki
Institute
Department

Funding Source
Organization University of Miyazaki
Organization
Division
Category of Funding Organization Other
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 09 Month 12 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 Open public recruiting
Date of protocol fixation
2017 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 09 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 09 Month 12 Day
Last modified on
2018 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033285

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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