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Efficacy and safety of Endoscopic Retrograde Stent Placement via Supra-papillar versus Trans-papillar Method for Malignant Biliary Obstruction: A Multicenter Prospective Randomized Study

Efficacy and safety of Endoscopic Retrograde Stent Placement via Supra-papillar versus Trans-papillar Method for Malignant Biliary Obstruction: A Multicenter Prospective Randomized Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0005572
Enrollment
84
Registered
2020-11-03
Start date
2021-01-13
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

None listed

Interventions

Procedure/Surgery : Midazolam and pethidine are administered appropriately in consideration of the patient s age and body weight, and the procedure is performed under conscious sedation. However, if t

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 18 years old or older 2. Patients with bile duct obstruction confined to the common bile duct in abdominal computed tomography or abdominal magnetic resonance imaging 3. If the cause of biliary obstruction is malignant neoplasm 4. When biliary obstruction cannot be treated surgically, or when surgery is rejected

Exclusion criteria

Exclusion criteria: 1. When bile duct stenosis is accompanied by intrahepatic bile duct or hepatic tract 2. If the distance from the distal boundary of the bile duct stenosis to the nipple is within 2cm 3. Subjects with uncontrolled cardiopulmonary disease that is difficult to sleep endoscopy 4. Subjects with uncontrolled coagulation disorder (INR >1.5 or platelet count <50,000 / cmm3) 5. Subjects who are currently receiving antithrombotic treatment but cannot stop or postpone 6. Pregnant women 7. Subjects who have not obtained informed consent 8. Patients who are unable to ERCP due to a deformed anatomy or gastrointestinal obstruction due to previous surgery

Design outcomes

Primary

MeasureTime frame
Stent patency

Secondary

MeasureTime frame
Technical success rate;Clinical success rate;Adverse reaction;Survial

Countries

Korea, Republic of

Contacts

Public ContactHyun Don Joo

Hanyang University Guri Hospital

aracd0523@naver.com+82-31-560-2592

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 8, 2026