Trial Information

Randomized Controlled Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy

The purpose of this study is to clarify whether resecting pylorus-ring decreases delayed
gastric emptying after pancreaticoduodenectomy and improves postoperative quality of
life(QOL)compared with preserving pylorus-ring. Delayed gastric emptying after
pancreaticoduodenectomy are important to affect the postoperative course and QOL. However,
there is no report that demonstrates the postoperative course between resecting pylorus-ring
and preserving pylorus-ring. We conducted a prospective randomized trial on 130 patients who
underwent pancreaticoduodenectomy comparing resecting pylorus-ring and preserving
pylorus-ring.

The primary endpoint was defined as the decrease of delayed gastric emptying. The secondary
endpoints were QOL, mortality and morbidity, including pancreatic fistula, 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) patients with severe
complications which were possible to prolong hospital stay, 2) patients who were diagnosed
inadequacy for this study by a physician, 3) patients with a previous gastric resection, and
4) patients without an informed consent.