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JAPANESE
国立保健医療科学院
JRCT ID: jRCTs042200064

Registered date:16/11/2020

A prospective clinical trial to evaluate the efficacy and safety of 7-mm-diamter covered biliary metal stent

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedPancreatic cancer
Date of first enrollment25/01/2021
Target sample size38
Countries of recruitment
Study typeInterventional
Intervention(s)Transpapillary Biliary stent implantation with 7 mm diameter covered metal stent

Outcome(s)

Primary OutcomeThe rate of the occurrence of acute pancreatitis after 7-mm-diamter covered biliary metal stent placement
Secondary OutcomeThe rate of early adverse events, the rate of late adverse events

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1)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.
Exclude criteria1)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/dL

Related Information

Contact

Public contact
Name Junya Sato
Address 1007 Shimonagakubo, Nagaizumi-cho,Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail ju.sato@scchr.jp
Affiliation Shizuoka Cancer Center
Scientific contact
Name Hirotoshi Ishiwatari
Address 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka Shizuoka Japan 411-8777
Telephone +81-55-989-5222
E-mail h.ishiwatari@scchr.jp
Affiliation Shizuoka Cancer Center