Preoperative biliary drainage using a newly designed fully covered self-expandable metal stent in patients with resectable malignant distal bile duct obstructio
- Conditions
- Neoplasms
- Registration Number
- KCT0006982
- Lead Sponsor
- Ajou University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 42
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method rate of preoperative stent dysfunction
- Secondary Outcome Measures
Name Time Method Technical success rate;Procedure related adverse events;rate of preoperative successful biliary drainage- Functional success rate