Comparison of Polyurethane plastic stent and Double layer stent in endoscopic biliary drainage: A single center randomized controlled trial. (PLAYED TRIAL)

Maruyama Hirotsugu0 sites94 target enrollmentNovember 7, 2023

Overview

No summary available.

Registry

who.int

Start Date

November 7, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Maruyama Hirotsugu

•1\) Patients with acute cholangitis or obstructive jaundice due to malignant disease who require endoscopic biliary drainage
•2\) Age: Persons aged 20 to 85 at the time of obtaining consent
•3\) Subjects who have given written consent of their own free will after receiving a sufficient explanation for participating in this research.

•1\) Cases after gastrointestinal surgery (with a history of Bilroth\-II reconstructive gastrectomy, Roux\-en Y reconstructive gastrectomy, cholangiojejunostomy, pancreaticoduodenectomy, etc., and difficult to perform ERCP with a duodenoscope) case)
•2\) Cases judged inappropriate for this study by the attending physician
•3\) Cases in which the duodenoscope cannot pass due to stricture in the upper gastrointestinal tract
•4\) Cases requiring multiple stents due to bile duct stenosis in the perihilar region
•5\) Cases in which procedures associated with stent placement are contraindicated (cannot be used if examination or cannulation of the pancreatic and bile ducts cannot be performed)
•6\) Cases with obstruction to the extent that a guidewire or stent cannot be inserted
•7\) Patients with contraindications to ERCP
•8\) Patients who have been enrolled in this study