Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy

Not Applicable

Completed

• Conditions: Pancreatic Cancer; Bile Duct Cancer; Ampullary Cancer; Duodenal Cancer; Pancreatitis
• Interventions: Procedure: pylorus-resecting pancreaticoduodenectomy; Procedure: pylorus-preserving pancreaticoduodenectomy

• Registration Number: NCT00639314
• Lead Sponsor: Wakayama Medical University

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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2008-03-14
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-20
• Primary Completion: 2009-05
• Status Verified: 2010-01
• Study Completion: 2011-03
• Last Update Submitted: 2011-06-23
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	pylorus-resecting pancreaticoduodenectomy	In PrPD, the stomach is divided just above the pylorus ring. the nearly total stomach more than 95% was preserved.
1	pylorus-preserving pancreaticoduodenectomy	In PpPD, the proximal duodenum was divided 3-4cm distal to the pylorus ring

Primary Outcome Measures

Name	Time	Method
delayed gastric empty after pancreaticoduodenectomy	1 month

Secondary Outcome Measures

Name	Time	Method
evaluation of quality of life, early and late complications after pancreaticoduodenectomy	2 years

Trial Locations

Locations (1)

Second Department of Surgery, Wakayama Medical University, School of Medicine, 811-1 Kimiidera; 🇯🇵 Wakayama, Japan