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

JRCT ID: jRCTs042200064

Registered date:16/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 25/01/2021
• Target sample size: 38
• 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
• Secondary Outcome: The rate of early adverse events, the rate of late adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• 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
• Source(s) of Monetary Support: Century Medical,Inc.