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A multicenter prospective randomized controlled trial of pass through biliary stricture using a novel, flexible-tip, torquable, angled tip guidewire

A multicenter prospective randomized controlled trial of pass through biliary stricture using a novel, flexible-tip, torquable, angled tip guidewire - TORQUE GW study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000029100
Enrollment
90
Registered
2017-09-12
Start date
2017-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

perihilar biliary stricture

Interventions

Use of angled type guidewire for passing biliary stricture. Use of straight type guidewire for passing biliary stricture

Sponsors

University of Miyazaki
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Success rate of each angled type and straight type guidewire passing perihilar biliary stricture within 5 minutes.

Secondary

MeasureTime frame
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).

Countries

Japan

Contacts

Public ContactYoshimasa Kubota

University of Miyazaki Department of Gastroenterology and Hepatology

y_kubota@med.miyazaki-u.ac.jp0985-85-9797

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026