UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029100 |
|---|---|
| Receipt number | 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 | 2024/03/18 19:03:15 |
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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 | Hiroshi |
| Middle name | |
| Last name | Kawakami |
Organization
University of Miyazaki
Division name
Department of Gastroenterology and Hepatology
Zip code
889-1692
Address
5200 Kihara, Kiyotake-cho, Miyazaki city, Miyazaki
TEL
0985-85-9797
hiropon@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Kubota |
Organization
University of Miyazaki
Division name
Department of Gastroenterology and Hepatology
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki
TEL
0985-85-9797
Homepage URL
y_kubota@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
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
Clinical Research from Miyazaki University Hospital
Address
5200 Kihara, Kiyotake, Miyazaki
Tel
0985-85-1510
igakubu_kenkyu@med.miyazaki-u.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
| 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
Completed
Date of protocol fixation
| 2017 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
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
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033285
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
