Ampullary Neoplasms, Bile Duct Neoplasms, Duodenal Neoplasms, Pancreatic Neoplasms, Pancreatitis
Conditions
Keywords
pancreaticoduodenectomy, pancreatic fistula, reconstruction, isolated Roux-en-Y
Brief 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.
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.
Interventions
surgical procedure
surgical procedure
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of pancreatic fistula | 3 months after operation |
Secondary
| Measure | Time frame |
|---|---|
| the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess | 3 months after operation |
Countries
Japan