Pancreatic cancer Pancreatic cancer, malignant distal biliary obstruction
Conditions
Interventions
Self-expandable metal stent placement
Anti-reflux metal stent placement
Sponsors
Sasahira Naoki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Unresectable pancreatic cancer 2)Prior history of endoscopic stenting with covered metal stent 3)Dysfunction of previous covered metal stent 4)Age >= 18 years 5)Performance status of 0-2 6)Expected survival time over 3 months 7)Sufficient organ function 1.Neutrophil count >= 1,000 /microL 2.Hemoglobin level >= 7.0 g/dL 3.Platelet count >= 50,000 /microL 4.Total bilirubin level =< 10 mg/dL 5.Aspartate aminotransferase level =< 300 U/L 6.Alanine aminotransferase level =< 300 U/L 7.Creatinine level =< 2.0 mg/dL 8)Patients who provided a written consent
Exclusion criteria
Exclusion criteria: 1)Concomitant hilar biliary obstruction 2)Patients who require more than one biliary stent 3)Unable to remove the previous covered metal stent 4)Prior history of endoscopic stenting with anti-reflux SEMS 5)Surgically altered anatomy other than Billroth 1 reconstruction 6)Indwelling PTBD or EUS-BD 7)Refractory cholangitis 8)Cholecystitis requiring gallbladder drainage 9)Liver abscess requiring abscess drainage 10)Liver failure 11)Indwelling gastroduodenal stent covering the duodenal papilla 12)Refractory gastrointestinal obstruction 13)Massive ascites requiring palliative paracentesis 14)Patients who would become lost to follow up right after metal stent placement 15)Patients who are pregnant or may become pregnant 16)Previously enrolled in this study 17)Patients who are considered inappropriate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Recurrent Biliary Obstruction | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Technical success rate 2)Clinical success rate 3)Early complication rate 4)Recurrent biliary obstruction rate 5)Adverse event rate 6)Success rate of stent removal 7)Overall survival after covered metal stent placement | — |
Contacts
Public ContactTsuyoshi Takeda
Cancer Institute Hospital of Japanese Foundation for Cancer Research
Outcome results
None listed