Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy
Pancreatic Neoplasms - Bile Duct Neoplasms - Ampullary Neoplasms - Duodenal Neoplasms - Pancreatitis
Conditions: official terms
Bile Duct Neoplasms - Duodenal Neoplasms - Neoplasms - Pancreatic Neoplasms - Pancreatitis
Conditions: Keywords
pancreaticoduodenectomy, pancreatic fistula, reconstruction, isolated Roux-en-Y
Study Type
Study Phase
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Billroth-II-type reconstruction Type: Procedure
Name: Isolated Roux-en-Y type reconstruction Type: Procedure
Overall Status
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.
Detailed 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
Criteria: Inclusion Criteria:

- the patients had undergone pancreatic head resection at Wakayama Medical University the patients obtained appropriate informed consent

Exclusion Criteria:

- young patients (less than 20-years-old)

- patients with severe complications which were possible to prolong hospital stay

- patients undergone hemodialysis

- patients combined resection of other organs

- patients who were diagnosed inadequacy for this study by a physician

- patients without an informed consent
Wakayama Medical University , Second Department of Surgery
811-1 Kimiidera, Wakayama, Wakayama, Japan
Status: Recruiting
Contact: Hiroki Yamaue, MD - +81-73-441-0612 - yamaue-h@wakayama-med.ac.jp
Start Date
June 2009
Completion Date
March 2014
Wakayama Medical University
Wakayama Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page