Hilar malignant biliary obstruction
Conditions
Interventions
Placement of 7mm double bare metal stent by side by side method.
Placement of 7mm single bare metal stent by side by side method.
Sponsors
Dokkyo Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed as malignant hilar biliary obstruction of Bismuth classification II or higher by histopathology or diagnostic imaging such as CT and MRI 2) Patients with obstructive jaundice (Total billirubin> 2mg / dL) due to malignant hilar biliary obstruction at the first drainage 3) Patients who are over 20 years old when obtaining consent 4) Patients who have been diagnosed as clinically non-resectable 5) Patients who are expected to survive more than 3 months 6) Patients who have obtained their written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Recurrent Biliary Obstruction | — |
Countries
Japan
Contacts
Public ContactKouhei Tsuchida
Dokkyo Medical University Department of gastroenterology
Outcome results
None listed