A prospective randomized control trial comparing newly designed 7mm double-bare metal stent and 7mm single-bare metal stent in patient with hilar malignant biliary strictures.
- Conditions
- Hilar malignant biliary obstruction
- Registration Number
- JPRN-UMIN000037958
- Lead Sponsor
- Dokkyo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 120
Not provided
1) Patients who cannot receive endoscopic treatment due to general condition, jaw, oral cavity and digestive tract condition 2) Patients who have more than ASA Classification class 4(with severe life-threatening systemic disease) poor general condition or severe complications (severe congestive heart failure, severe coronary failure) 3) Patients after reconstruction of upper gastrointestinal tract other than Billroth-I reconstruction 4) Patients after excision of the duodenal papilla, after papilloplasty, and after surgical biliary anastomosis 5) Patients who are considering radical resection, radiation therapy, particle beam therapy, photodynamic therapy, high-intensity focused ultrasound 6) Patients whose periodic replacement of PS is considered desirable 7) Patients after biliary stent placement that cannot be removed 8) Patients whose endoscopic drainage is considered to be ineffective because of severely severe biliary branching due to huge intrahepatic cholangiocarcinoma or extensive cholangiocarcinoma 9) Patients who judge that uncovered MS placement should be avoided when tumor bleeding is severe, or when it is composed of a luminal growth type papillary tumor such as IPNB. 10) Patients with uncontrolled active infection other than acute cholangitis 11) Patients with primary sclerosing cholangitis, IgG4-related cholangitis, primary biliary cholangitis 12) Patients who have difficulty in determining the yellowing effect due to severe cirrhosis 13) Patients who have high total billirubin due to hemolytic disease and may not have obstructive jaundice 14) Patients with a history of allergy to biliary contrast media and severe allergies to angiographic media 15) Patients who are pregnant or may be pregnant 16) Patients whose follow-up is considered impossible at the study participating facility or related facilities that can be in close contact
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Recurrent Biliary Obstruction
- Secondary Outcome Measures
Name Time Method