Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy

Not Applicable

• Conditions: Pancreatic Neoplasms; Bile Duct Neoplasms; Ampullary Neoplasms; Duodenal Neoplasms; Pancreatitis
• Interventions: Procedure: Billroth-II-type reconstruction; Procedure: Isolated Roux-en-Y type reconstruction

• Registration Number: NCT00915863
• Lead Sponsor: Wakayama Medical University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2009-05-22
• Study Start: 2009-06
• Study First Submitted QC: 2009-06-05
• Study First Posted: 2009-06-08
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-25
• Last Update Posted: 2010-01-26
• Primary Completion: 2013-10
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Billroth-II-type	Billroth-II-type reconstruction	Billroth-II-type reconstruction after pancreaticoduodenectomy
Isolated Roux-en-Y	Isolated Roux-en-Y type reconstruction	Isolated Roux-en-Y type reconstruction after pancreaticoduodenectomy

Primary Outcome Measures

Name	Time	Method
the incidence of pancreatic fistula	3 months after operation

Secondary Outcome Measures

Name	Time	Method
the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess	3 months after operation

Trial Locations

Locations (1)

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