Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy

Pancreatic Neoplasms Clinical Trial

Official title: A Prospective Randomized Controlled Trial Comparing Isolated Roux-en-Y Reconstruction With Billroth-II-type Reconstruction After Pancreaticoduodenectomy

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the incidence of complications with the isolated Roux-en-Y reconstruction after pancreaticoduodenectomy in pancreatic tumor and periampullary tumor patients. A prospective randomized controlled trial was conducted to compare the incidence of complications with isolated Roux-en-Y reconstruction with those of Billroth-II-type reconstruction after pancreaticoduodenectomy.

Clinical Trial Description

The purpose of this study is to clarify whether isolated Roux-en-Y reconstruction declines the incidence of postoperative complications after pancreaticoduodenectomy compared with Billroth-II-type reconstruction. Especially, it is important to decline the incidence of pancreatic fistula, because pancreatic fistula affects a postoperative course. However, there is no report that demonstrated postoperative complications of isolated Roux-en-Y compared with those of Billroth-II-type reconstruction. We conducted a prospective randomized trial on patients who underwent pancreaticoduodenectomy.

Patients with pancreatico-biliary disease who were performed pancreaticoduodenectomy at Wakayama Medical University Hospital.

The primary endpoint was defined as the incidence of pancreatic fistula. The secondary endpoints were the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated at Wakayama Medical University Hospital (WMUH) for pancreatic head and periampullary disease, and appropriate informed consent was obtained. Exclusion criteria was 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ampullary Neoplasms
• Bile Duct Neoplasms
• Duodenal Neoplasms
• Neoplasms
• Pancreatic Neoplasms
• Pancreatitis

• NCT number: NCT00915863
• Study type: Interventional
• Source: Wakayama Medical University
• Contact: Hiroki Yamaue, MD
• Phone: 81-73-441-0612
• Email: yamaue-h@wakayama-med.ac.jp
• Status: Recruiting
• Phase: N/A
• Start date: June 2009
• Completion date: March 2014