A prospective randomized controlled trial comparing isolated Roux-en-Y reconstruction with Billroth-II-type reconstruction after pancreaticoduodenectomy

UMIN ID: UMIN000001967

Registered date:13/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: pancreatic cancer, biliary cancer, duodenal cancer, pancreatic tumor, biliary tumor,duodenal tumor
• Date of first enrollment: 2009/05/01
• Target sample size: 150
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Reconstruction after pancreaticoduodenectomy with Billroth-II-type
Reconstruction after pancreaticoduodenectomy with isolated Roux-en-Y

Outcome(s)

• Primary Outcome: pancratic fistula
• Secondary Outcome: the incidence of other postoperative complications, mortality, delayed ggastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) young patients (less than 20-year-old), 2) patients with severe complications which were possible to prolong hospital stay, 3) patients undergone hemodialysis, 4) patients combined resection of other organs, 5) patients who were diagnosed inadequacy for this study by a physician, and 6) patients without an informed consent

Related Information

• Primary Sponsor: Wakayama Medical University
• Source(s) of Monetary Support: Wakayama Medical University