Ampullary Cancer, Bile Duct Cancer, Duodenal Cancer, Pancreatic Cancer, Pancreatitis
Conditions
Keywords
pylorus-preserving pancreaticoduodenectomy, pylorus-resecting pancreaticoduodenectomy, randomized controlled trial, delayed gastric empty, quality of life
Brief summary
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).
Detailed description
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.
Interventions
pylorus-preserving resection is division of the duodenum 3-4cm distal to the pylorus
In PrPD, the stomach is divided just above the pylorus ring. The nearly total stomach more than 95% was preserved.
Sponsors
Study design
Eligibility
Inclusion criteria
* On the basis of whether pancreatic head resection was anticipated at WMUH for pancreatic head and periampullary disease, and appropriate informed consent was obtained.
Exclusion criteria
* Patients with severe complications which were possible to prolong hospital stay * Patients who were diagnosed inadequacy for this study by a physician * Patients who could not be placed a pancreatic stent tube * Patients without an informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| delayed gastric empty after pancreaticoduodenectomy | 1 month |
Secondary
| Measure | Time frame |
|---|---|
| evaluation of quality of life, early and late complications after pancreaticoduodenectomy | 2 years |
Countries
Japan