Endoscopic treatment for walled-off necrosis after acute pancreatitis using plastic stents vs. nobel dedicated biflanged metal stent, prospective randomized controlled trial

UMIN ID: UMIN000015322

Registered date:02/10/2014

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Walled-off necrosis
• Date of first enrollment: 2014/10/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

In the patients of PS group, conventional EUS guided transmural drainage using plastic stents is performed. In the patients of BFMS group, EUS-guided transmural drainage using a novel dedicated biflanged metal stent is performed.
In the patients of BFMS group, EUS-guided transmural drainage using a novel dedicated biflanged metal stent is performed.

Outcome(s)

• Primary Outcome: technical success rate, clinical success rate adverse event rate, mortality rate

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 99years-old
• Gender: Male and Female
• Exclude criteria: 1)Cases with sever complication in other organs except original disease 2)Cases having impossibility of cessation of anticoagulant 3)Cases with pregnancy or suspect of pregnancy 4)Cases with malignant cancer not having more than a half year prognosis 5)Cases that the size of lesion is less than 3 cm 6)Cases having difficulty in endoscopic approach 7)Cases having difficulty in visualization of lesion on EUS 8)Cases judged by principal investigator to be inadequate as subjects

Related Information

• Primary Sponsor: Tokyo Medical University Hospital Department of Gastroenterology and Hepatology
• Source(s) of Monetary Support: none