Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy

Wakayama Medical University

Status: Unknown

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

Treatments: Procedure: Billroth-II-type reconstruction; Procedure: Isolated Roux-en-Y type reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT00915863

WP-0901

Details and patient eligibility

About

The purpose of this study is to evaluate the incidence of complications with the isolated Roux-en-Y reconstruction after pancreaticoduodenectomy in pancreatic tumor and periampullary tumor patients. A prospective randomized controlled trial was conducted to compare the incidence of complications with isolated Roux-en-Y reconstruction with those of Billroth-II-type reconstruction after pancreaticoduodenectomy.

Full description

The purpose of this study is to clarify whether isolated Roux-en-Y reconstruction declines the incidence of postoperative complications after pancreaticoduodenectomy compared with Billroth-II-type reconstruction. Especially, it is important to decline the incidence of pancreatic fistula, because pancreatic fistula affects a postoperative course. However, there is no report that demonstrated postoperative complications of isolated Roux-en-Y compared with those of Billroth-II-type reconstruction. We conducted a prospective randomized trial on patients who underwent pancreaticoduodenectomy.

Patients with pancreatico-biliary disease who were performed pancreaticoduodenectomy at Wakayama Medical University Hospital.

The primary endpoint was defined as the incidence of pancreatic fistula. The secondary endpoints were the incidence of other postoperative complications, mortality, delayed gastric emptying, 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) young patients (less than 20-year-old), 2) patients with severe complications which were possible to prolong hospital stay, 3) patients undergone hemodialysis, 4) patients combined resection of other organs, 5) patients who were diagnosed inadequacy for this study by a physician, and 6) patients without an informed consent.

Enrollment: 150 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• the patients had undergone pancreatic head resection at Wakayama Medical University the patients obtained appropriate informed consent

Exclusion criteria

• young patients (less than 20-years-old)
• patients with severe complications which were possible to prolong hospital stay
• patients undergone hemodialysis
• patients combined resection of other organs
• patients who were diagnosed inadequacy for this study by a physician
• patients without an informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Billroth-II-type

Active Comparator group

Description:

Billroth-II-type reconstruction after pancreaticoduodenectomy

Treatment:

Procedure: Billroth-II-type reconstruction

Isolated Roux-en-Y

Experimental group

Description:

Isolated Roux-en-Y type reconstruction after pancreaticoduodenectomy

Treatment:

Procedure: Isolated Roux-en-Y type reconstruction