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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-07-31

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.

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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.

Conditions

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Pancreatic Neoplasms

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Reinforced staple

Endo GIA Reinforced Reload with Tri-Staple technology

Group Type EXPERIMENTAL

Endo GIA Reinforced Reload with Tri-Staple technology

Intervention Type DEVICE

Device:Endo GIA Reinforced Reload with Tri-Staple technology

Interventions

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Endo GIA Reinforced Reload with Tri-Staple technology

Device:Endo GIA Reinforced Reload with Tri-Staple technology

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. disease of pancreatic body and tail
2. PS (ECOG Performance Status Scale)0-1
3. Age: 20 years or older
4. 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
5. Patients who can provide written informed consent

Exclusion Criteria

1. Patients with severe ischemic cardiac disease
2. Patients with severe liver cirrhosis or active hepatitis
3. Patients with respiratory illness that requires oxygen administration
4. Patients with chronic renal failure requiring dialysis
5. Patients requiring other organ resection
6. Patients who are unfit for the study as determined by the attending physician

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No