A multicenter, randomized, controlled trial to reveal the efficacy of fully covered vs uncovered SEMS for malignant biliary obstruction caused by unresectable pancreatic cancer (confirmatory Trial)
- Conditions
- malignant biliary obstruction caused by unresectable pancreatic cancermalignant biliary obstruction, unresectable pancreatic cancer
- Registration Number
- JPRN-jRCTs052210032
- Lead Sponsor
- Takenaka Mamoru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 300
(1)Unresectable pancreatic cancer (UR-LA,UR-M) causing distal biliary obstruction
(2)Pathologically confirmed diagnosis or patients with suspected pancreatic cancer who are scheduled to undergo a pathological examination(It does not matter whether it is by cytology or histology)
(3)Patients aged 20 and over who have given sufficient explanation about the content of the study and have proved informed consent created by the patient's will based on the understanding of the content. (In principle, cancer notification shall be given.)
(1)Cases with Performance status of 4
(2)Cases with serious complications in other organs.such as ASA classification 3 or higher (Subject who is dialysis also excluded)
(3)Cases with hilar biliary obstruction
(4)Cases with bordeline resectable pancreatic cancer (BR), hilar biliary obstruction associated with lymphadenopathy
(5)Cases where informed consent cannot be obtained
(6)Cases with Uncontrollable cholangitis
(7)Cases with an expected prognosis of less than 3 months
(8)Cases where the condition worsens after the first biliary drainage
(9)Cases judged by the investigator (in-charge doctor) to be inappropriate as a subject
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of stent patency
- Secondary Outcome Measures
Name Time Method (1) procedure succss rate, (2) clinical success rate, (3) re-intervention success rate, (4) reason of stent occlusion, (5) survival period, (6) adverse event rate, (7) chemotherapy after biliary drainage