Trial Information

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

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.