The efficacy and safety of a single pigtail plastic stent for hilar and intrahepatic biliary obstruction: A multi-center, prospective, randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0012037

Enrollment

140

Registered

2026-05-26

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

None listed

Interventions

Medical Device : When a patient arrives in the ERCP room, the performing physician confirms the patient's group assignment for a specific group (either the existing conventional straight plastic stent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult patients aged 20 and above with confirmed malignant biliary stricture in radiological and endoscopic cholangiography - Patients demonstrating clinical symptoms of obstruction and radiological evidence of extrahepatic bile duct obstruction, deemed appropriate for malignant biliary stricture based on the clinician's assessment - Patients requiring endoscopic retrograde cholangiopancreatography (ERCP) for biliary drainage as part of the treatment

Exclusion criteria

Exclusion criteria: 1. Pregnant patients 2. Patients under consideration for or with the potential for surgical resection 3. Patients with difficulty in endoscopic ampullary access due to abdominal surgery and duodenal obstruction 4. Patients who have not provided informed consent

Design outcomes

Primary

Measure	Time frame
stent patency rate	—

Secondary

Measure	Time frame
Mean patency duration;technical & clinical success rates;stent spontaneous migration rates;perforation; bleeding;cholecystitis	—

Countries

Korea, Republic of

Contacts

Public ContactIn Rae Cho

Seoul National University Hospital

inrae0428@hanmail.net+82-2-2072-1726

Outcome results