Evaluation of Isolated Roux-en-Y Reconstruction After Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomized Controlled Trial Comparing Isolated Roux-en-Y Reconstruction With Billroth-II-type Reconstruction After Pancreaticoduodenectomy

Conditions
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Pancreatic Neoplasms, Bile Duct Neoplasms, Ampullary Neoplasms, Duodenal Neoplasms, Pancreatitis

Intervention / Treatment
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* Procedure: Billroth-II-type reconstruction
* Procedure: Isolated Roux-en-Y type reconstruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Billroth-II-type<br>Billroth-II-type reconstruction after pancreaticoduodenectomy | Procedure: Billroth-II-type reconstruction<br>* surgical procedure<br>* Other names: Child reconstruction;|
| Experimental: Isolated Roux-en-Y<br>Isolated Roux-en-Y type reconstruction after pancreaticoduodenectomy | Procedure: Isolated Roux-en-Y type reconstruction<br>* surgical procedure<br>* Other names: Roux-en-Y reconstruction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of pancreatic fistula |  | 3 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of other postoperative complications, mortality, delayed gastric emptying, intra-abdominal hemorrhage, and intra-abdominal abscess |  | 3 months after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreaticoduodenectomy, pancreatic fistula, reconstruction, isolated Roux-en-Y