Unresectable Malignant Biliary Obstruction
Conditions
Interventions
EUS-SBD group:EUS-guided single-point puncture of the intrahepatic bile duct or common bile duct through the stomach or duodenum, followed by guidewire placement and insertion of a double-pigtail plas
EUS-DBD group:EUS-guided puncture of the intrahepatic bile duct or common bile duct through the stomach or duodenum, with guidewire selective cannulation to the duodenal papilla or biliary-enteric ana
Sponsors
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years and provision of signed informed consent; 2. Radiologically confirmed malignant biliary obstruction with concomitant upstream biliary duct dilation; 3. Indication for biliary drainage with either contraindication for ERCP (including patients with surgically altered anatomy) or prior failed ERCP biliary drainage. Failed ERCP is defined as the inability to successfully cannulate the common bile duct by an experienced senior endoscopist (performing >100 ERCPs annually, with a lifetime case volume >500); 4. Life expectancy greater than 3 months; 5. Elevated serum total bilirubin, with a direct bilirubin fraction accounting for >= 60% of the total bilirubin; 6. American Society of Anesthesiologists (ASA) physical status classification of I to III.
Exclusion criteria
Exclusion criteria: 1. Multifocal liver metastases involving >30% of the hepatic parenchyma; 2. Hilar cholangiocarcinoma classified as Bismuth-Corlette type III or IV; 3. Life expectancy of less than 3 months; 4. Uncorrectable coagulation disorders; 5. Cardiac, pulmonary, or hepatic failure; 6. Pregnancy or lactation; 7. Unwillingness or inability to provide written informed consent; 8. American Society of Anesthesiologists (ASA) physical status classification of IV or V.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reintervention rate for stent dysfunction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;Clinical success rate;Postoperative length of hospital stay;Intervention-free survival;Survival;Quality of life; | — |
Countries
China
Contacts
Public ContactShen Shanshan
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Outcome results
None listed