A prospective clinical trial to evaluate the efficacy and safety of 7-mm-diamter covered biliary metal stent
- Conditions
- Pancreatic cancer
- Registration Number
- JPRN-jRCTs042200064
- Lead Sponsor
- Ishiwatari Hirotoshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 38
1)A patient who is planned to undergo first endoscopic biliary stent placement for jaundice or cholangitis.
2)A patient with resectable or borderline resectable pancreatic cancer which is diagnosed by contrast CT.
3)A patient with distal biliary obstruction.
4)A patient >= 20 years old.
5)A patient with performance status of 0-1.
6)Will be followed for 6 months after treatment.
7)Written informed consent.
1)A patient with hilar biliary obstruction
2)A patient who underwent endoscopic biliary stent placement
3)A patient with duodenal obstruction/stenosis
4)A patient with acute pancreatitis
5)A patient who has a history of reconstruction method other than Billroth 1 anastomosis after gastrectomy.
6)A patient who cannot stop antiplatelet and coagulant drug.
7)A patient with mental disorder
8)A patient with severe organs failure, such as liver, bone marrow, and kidney.
ANC < 1000 mm3, Platelet count < 50000 mm3,
Hemoglobin < 8.0g/dL, Creatinine >= 2.0mg/d
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of the occurrence of acute pancreatitis after 7-mm-diamter covered biliary metal stent placement
- Secondary Outcome Measures
Name Time Method The rate of early adverse events, the rate of late adverse events