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 |
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Health condition(s) or Problem(s) studied | Pancreatic cancer |
Date of first enrollment | 25/01/2021 |
Target sample size | 38 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | Transpapillary Biliary stent implantation with 7 mm diameter covered metal stent |
Outcome(s)
Primary Outcome | The rate of the occurrence of acute pancreatitis after 7-mm-diamter covered biliary metal stent placement |
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Secondary Outcome | The rate of early adverse events, the rate of late adverse events |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 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. |
Exclude criteria | 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/dL |
Related Information
Primary Sponsor | Ishiwatari Hirotoshi |
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Secondary Sponsor | |
Source(s) of Monetary Support | Century Medical,Inc. |
Secondary ID(s) |
Contact
Public contact | |
Name | Junya Sato |
Address | 1007 Shimonagakubo, Nagaizumi-cho,Sunto-gun, Shizuoka Shizuoka Japan 411-8777 |
Telephone | +81-55-989-5222 |
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 |
h.ishiwatari@scchr.jp | |
Affiliation | Shizuoka Cancer Center |