Phase II study of endoscopic ultrasound-guided choledochoduodenostomy for biliary drainage treatment of patients with malignant biliary obstruction

UMIN ID: UMIN000001388

Registered date:23/09/2008

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Malignant biliary obstruction
• Date of first enrollment: 2008/09/01
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): EUS-guided choledochoduodenostomy (EUS-CDS) was approached from the first portion of the duodenum using a convex echoendoscope and a needle knife. Second steps of the procedure are passage dilatation and the plastic stent placement. All procedures were performed through the accessory channel of the echoendoscope over the guide wire.

Outcome(s)

• Primary Outcome: Grade and incidence of adverse events Rate of successful completion of procedure
• Secondary Outcome: patency period of stent

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Obstruction of upper GI tract 2. Obstruction of upper part of extrahepatic biliary duct 3. History or schedule of radiotherapy for duodenum 4. Inappropriate for this trial by doctors

Related Information

• Primary Sponsor: Department of Gastroenterology Aichi Cancer Center Hospital
• Source(s) of Monetary Support: None