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)

JRCT ID: jRCTs052210032

Registered date:02/06/2021

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: malignant biliary obstruction caused by unresectable pancreatic cancer
• Date of first enrollment: 05/07/2021
• Target sample size: 300
• Study type: Interventional

Intervention(s)

FCMCS: groups who are used fully covered HILZO stents for malignant biliary obstruction caused by unresectable pancreatic cancer
UCMS: groups who are used uncovered HILZO stents for malignant biliary obstruction caused by unresectable pancreatic cancer

Outcome(s)

• Primary Outcome: Duration of stent patency
• Secondary Outcome: (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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(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.)

Exclude criteria

(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

Related Information

• Primary Sponsor: Takenaka Mamoru
• Source(s) of Monetary Support: Zeon Medical Inc.