A Prospective, Multi-center Trial for Reinforced Staple During Distal Pancreatectomy

Study Overview
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Brief Summary
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The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial.

Detailed Description
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Reducing the incidence of pancreatic fistula is the most important issue in pancreatectomy. There is no certain view on the pancreatic resection method to reduce pancreatic fistula in distal pancreatectomy.This study will be conducted to scientifically investigate the impact of Endo GIA Reinforced Reload with Tri-Staple Technology in distal pancreatectomy. The aim of this study is to evaluate if the Endo GIA Reinforced Reload with Tri-Staple Technology reduce incidence of pancreatic fistula (ISGPF grade B and C) after distal pancreatectomy by a prospective, multi-center trial.

Official Title
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A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload With Tri-Staple Technology During Distal Pancreatectomy

Conditions
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Pancreatic Neoplasms

Intervention / Treatment
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* Device: Endo GIA Reinforced Reload with Tri-Staple technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: disease of pancreatic body and tail PS (ECOG Performance Status Scale)0-1 Age: 20 years or older distant metastases are not diagnosed preoperatively. Eligible for this clinical study when only distal pancreatectomy contributes to the favorable prognosis even if patients with pancreatic neuroendocrine cancer have the liver metastasis Patients who can provide written informed consent Exclusion Criteria: Patients with severe ischemic cardiac disease Patients with severe liver cirrhosis or active hepatitis Patients with respiratory illness that requires oxygen administration Patients with chronic renal failure requiring dialysis Patients requiring other organ resection Patients who are unfit for the study as determined by the attending physician

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reinforced staple<br>Endo GIA Reinforced Reload with Tri-Staple technology | Device: Endo GIA Reinforced Reload with Tri-Staple technology<br>* Device:Endo GIA Reinforced Reload with Tri-Staple technology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pancreatic fistula grade B/C |  | Ninety days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pancreatic fistula defined by ISGPF classification |  | Ninety days after operation | 
| Incidence of pancreatic fistula grade C defined by ISGPF classification |  | Ninety days after operation | 
| Incidence of intraabdominal bleeding |  | Ninety days after operation | 
| Morbidity |  | Ninety days after operation | 
| Mortality |  | Ninety days after operation | 
| Postoperative hospital stay |  | Ninety days after operation | 
| Hemostasis condition of staple line |  | during operation | 
| Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line |  | during operation | 
| Period of drain insertion |  | Ninety days after operation | 
| Damage of pancreatic stump |  | during operation | 
| Frequency of additional suture of pancreatic stump |  | during operation | 
| Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma |  | Ninety days after operation |