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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1052230124
Enrollment
94
Registered
2023-11-07
Start date
2024-01-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute cholangitis, obstructive jaundice Acute cholangitis, obstructive jaundice

Interventions

Randomized controlled trial

Sponsors

Maruyama Hirotsugu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

MeasureTime frame
Stent patency

Secondary

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

Contacts

Public ContactHirotsugu Maruyama

Department of Gastroenterology, Osaka Metropolitan University Graduate School of Medicine

hiromaruyama99@omu.ac.jp+81-6-6645-3811

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026