malignant distal biliary obstruction in unresectable pancreatic cancer
Conditions
Interventions
A fully covered self-expandable metallic stent (FCSEMS) "
HILZO STENTS Biliary Covered Stent (Spiral Cover Double Head)"
is placed across the papilla through endoscopic retrograde cholangiopancreatography (ERCP)-related techniques.
Sponsors
Kobe University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The patient is 18 years of age or older at the time of obtaining consent. 2.The patient has been diagnosed with pancreatic cancer through imaging, cytology, or histology. 3.The patient is deemed unsuitable for surgical resection due to tumor stage or surgical risk. 4.The patient's performance status (PS) is 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) scale. 5.The patient has provided written informed consent to participate in the trial.
Exclusion criteria
Exclusion criteria: 1.Presence of bile duct stricture that requires the placement of a stent in the hilar or intrahepatic bile ducts. 2.History of cholecystectomy (gallbladder removal). 3.Surgical reconstruction with a non-Billroth I technique (postoperative gastrointestinal reconstruction other than Billroth I). 4.Diagnosis or suspicion of duodenal stenosis based on symptoms or imaging findings. 5.History of bile duct metal stent placement. 6.Preoperative diagnosis of acute cholecystitis or acute pancreatitis. 7.Liver failure where bile duct drainage is unlikely to decrease total bilirubin levels below 3 mg/dL. 8.Other conditions where the physician deems participation in the trial inappropriate for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of acute cholecystitis within 30 days of stent placement | — |
Countries
Japan
Contacts
Public ContactAkira Shirohata
Kobe University Graduate School of Medicine Division of Gastroenterology, Department of Internal Medicine
Outcome results
None listed