The efficacy and safety of a half bend pigtail plastic stent for malignant hilar obstruction

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009047

Enrollment

Registered

2023-12-15

Start date

2024-02-22

Completion date

Unknown

Last updated

2025-07-21

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 patients eligibility for a specific group (either the existing double pigtail plastic stent group or the

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: Pregnant patients Patients under consideration for or with the potential for surgical resection Patients with bile duct cancer other than hilar cholangiocarcinoma Patients with difficulty in endoscopic ampullary access due to abdominal surgery and duodenal obstruction Patients who have not provided informed consent

Design outcomes

Primary

Measure	Time frame
patency rate, 3 months;Mean patency duration	—

Secondary

Measure	Time frame
technical & clinical success rates;stent spontaneous migration rates;perforation ;bleeding;cholangitis	—

Countries

Korea, Republic of

Contacts

Public ContactSanghyub Lee

Seoul National University Hospital

gidoctor@snu.ac.kr+82-2-2072-4891

Outcome results