Preoperative biliary drainage using a newly designed fully covered self-expandable metal stent in patients with resectable malignant distal bile duct obstruction

Preoperative biliary drainage using a newly designed fully covered self-expandable metal stent in patients with resectable malignant distal bile duct obstruction: A prospective multicenter feasibility study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006982

Enrollment

Registered

2022-02-07

Start date

2022-05-10

Completion date

Unknown

Last updated

2025-04-07

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, Procedure/Surgery : 1. The procedure is performed under fluoroscopic endoscopic guidance, and the exact location and length of the biliary stricture are determined in advance. 2. A gui

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Anyone who meets all of the following criteria can enroll this study. 1. Adults over 19 years old. 2. Resectable pancreatic cancer, extrahepatic bile duct cancer, duodenal papillary cancer, and border resectable pancreatic cancer 3. Malignant distal biliary obstruction, 2cm distal to the liver hilum 4. American Society of Anesthesiologists physical status I or II 5. Patients with informed consent 6. Serum total bilirubin (total bilirubin) 5 mg/dL or higher

Exclusion criteria

Exclusion criteria: Subjects who meet one or more of the following criteria are excluded from the study. 1. Unsuitable for surgery owing to metastasis, locally advanced stage, high operation risk, or patient's wishes 2. History of prior endoscopic or percutaneous biliary or gallbladder drainage 3. Surgically altered anatomy or duodenal stricture 4. Cystic duct obstruction on radiologic study 5. Acute cholecystitis or pancreatitis 6. Unsuitable for ERCP

Design outcomes

Primary

Measure	Time frame
rate of preoperative stent dysfunction	—

Secondary

Measure	Time frame
Technical success rate;Procedure related adverse events;rate of preoperative successful biliary drainage- Functional success rate	—

Countries

Korea, Republic of

Contacts

Public ContactMin Jae Yang

Ajou University Hospital

ymj@ajou.ac.kr+82-31-219-7821

Outcome results