Malignant lower biliary obstruction
Conditions
Interventions
Endoscopic ultrasound-guided bile duct drainage using a new fully-covered metallic stent (AXIOS Stent)
Sponsors
Tokyo Medical University Hospital, 4th Department of Internal Medicine
Aichi Prefectural Cancer Center Department of Gastroenterology Kinki University Department of Medicine Department of Gastroenterology Tokyo University Department of Gastroenterology Teine Keijinkai Hospital Center for Gastroenterology Chinese University of Hong Kong&
#8232
Prince of Wales Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 20 years of age or older. 2. Subjects suitable for EUS-guided drainage. 3. Subjects with obstructive jaundice (total serum bilirubin > 3.0 mg/dL) and subjects with bile duct inflammation due to malignant lower biliary duct obstruction for which histological evidence has been obtained. 4. Subjects in whom dilation of the bile duct has been observed using abdominal ultrasound,CT, or MRCP. 5. Subjects meeting the standards in whom ERCP was unsuccessful: 10 times pancreatic duct cannulation or 10 min procedure. a. Subjects in whom the papilla cannot be observed or cannot be reached by the scope. Subjects in whom selective bile duct cannulation is impossible (subjects who have a tumorous duodenum, invasion of the papilla, or juxtapapillary duodenal diverticulum, or who present anatomical difficulties.) b. Subjects in whom bile duct intubation has been attempted at least five times or for at least ten minutes. c. Subjects in whom transpapillary passage of the stent to the site of stenosis is impossible and who are in the following high risk groups for pancreatitis following ERCP: a. Subjects with past histories of pancreatitis following ERCP b. Subjects with hereditary pancreatitis. 6. Subjects who have themselves voluntarily given written consent to participate in the study after receiving and fully understanding a full explanation.
Exclusion criteria
Exclusion criteria: 1. Subjects who are pregnant or nursing 2. Abnormal coagulatory function (INR of 1.5 or greater that cannot be corrected by administering blood plasma, or a platelet count of less than 50.000/mm3.) 3. Subjects with biliary obstruction of the hepatic portal region. 4. Subjects who are scheduled to undergo pancreaticoduodenectomy. 5. Subjects with past histories of surgical treatment of the bile duct Roux-en-Y syndrome following gastric resection 6. Subjects who are in poor mental condition or who have mental disorders. Subjects who may not be able to understand the details of this study. 7. Subjects with poor presurgical or postsurgical assessments. 8. Subjects thought to have a prognosis of less than one month 9. Subjects with acute bleeding of the digestive tract 10. Subjects with end-stage hepatic disorders associated with portal hypertension, varicose veins, or ascites. 11. Subjects with 30% or greater liver metastasis 12. Subjects who present a difficult endoscopic approach. 13. Subjects with performance status 4. 14. Subjects with serious complications in other organs 15. Subjects from whom informed consent cannot be obtained 16. Subjects who are otherwise judged by the investigator or subinvestigator to be ineligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Safety: Incidence and severity of procedural accidents associated with the indwelling of the stent. Severity of procedural accidents will follow the diagnostic criteria of Cotton et al. 2) Success Rate of the Procedure: Confirmation of puncture, bile duct imaging, stent indwelling, and flow of bile (by cholangioscope, when possible) 3) Treatment Response Rate: Decrease in bilirubin of 50% or greater within two weeks, and 3 mg/dL or greater within four weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life (QOL): Assessed after one, four, and twelve weeks according to the EORTC-QLQ-30 instrument. | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactTakao Itoi
Tokyo Medical University Hospital 4th Department of Internal Medicine
Outcome results
None listed