Comparative study on double layer stent in endoscopic biliary drainage: RCT

JRCT ID: jRCT1052230124

Registered date:07/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute cholangitis, obstructive jaundice
• Date of first enrollment: 12/01/2024
• Target sample size: 94
• Study type: Interventional
• Intervention(s): Randomized controlled trial

Outcome(s)

• Primary Outcome: Stent patency

Secondary Outcome

1) Procedure success rate
2) Clinical improvement rate
3) Frequency and content of adverse events
4) Details of stent occlusion

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Maruyama Hirotsugu