Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy

Wakayama Medical University

Status: Completed

Conditions: Bile Duct Cancer; Pancreatitis; Ampullary Cancer; Duodenal Cancer; Pancreatic Cancer

Treatments: Procedure: pylorus-preserving pancreaticoduodenectomy; Procedure: pylorus-resecting pancreaticoduodenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00639314

WP-0502

Details and patient eligibility

About

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).

Full 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.

Enrollment: 130 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

130 participants in 2 patient groups

1

Experimental group

Description:

In PpPD, the proximal duodenum was divided 3-4cm distal to the pylorus ring

Treatment:

Procedure: pylorus-preserving pancreaticoduodenectomy

2

Active Comparator group

Description:

In PrPD, the stomach is divided just above the pylorus ring. the nearly total stomach more than 95% was preserved.

Treatment:

Procedure: pylorus-resecting pancreaticoduodenectomy