NCT00639314

Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Wakayama Medical University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer
• Bile Duct Cancer
• Ampullary Cancer
• Duodenal Cancer
• Pancreatitis

Interventions

Type	Name	Description
PROCEDURE	pylorus-preserving pancreaticoduodenectomy	pylorus-preserving resection is division of the duodenum 3-4cm distal to the pylorus
PROCEDURE	pylorus-resecting pancreaticoduodenectomy	In PrPD, the stomach is divided just above the pylorus ring. The nearly total stomach more than 95% was preserved.

Timeline

• Start date: 2005-10-01
• Primary completion: 2009-05-01
• Completion: 2011-03-01
• First posted: 2008-03-20
• Last updated: 2011-06-27

Locations

1 site across 1 country: Japan