Feasibility and efficacy of EUSguided drainage and endoscopic necrosectomy using a novel lumen-apposing metal stent

UMIN ID: UMIN000021347

Registered date:04/03/2016

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: walled-off necrosis
• Date of first enrollment: 2015/10/19
• Target sample size: 20
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): EUS-guided drainage and direct endoscopic necrosectomy using a novel metal stent

Outcome(s)

• Primary Outcome: Clinical treatment rate for WON

Key inclusion & exclusion criteria

• Age minimum: 18years-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: Department of Gastroenterology and Hepatology, Tokyo Medical University
• Source(s) of Monetary Support: Department of Gastroenterology and Hepatology, Tokyo Medical University