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

July 20, 2016 updated by: Hiroki Yamaue, Wakayama Medical University

A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload With Tri-Staple Technology During 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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amagasaki, Hyogo, Japan
        • Kansai Rosai Hospital
      • Hirakata, Osaka, Japan
        • Kansai Medical University
      • Hiroshima, Hiroshima, Japan
        • Hiroshima University
      • Kashihara, Nara, Japan
        • Nara Medical University
      • Kobe, Hyogo, Japan
        • Kobe University
      • Kyoto, Japan
        • Kyoto Prefectural University of Medicine
      • Nagoya, Aichi, Japan
        • Nagoya University
      • Nishinomiya, Hyogo, Japan
        • Hyogo College of Medicine
      • Osaka, Japan
        • Osaka University
      • Sayama, Osaka, Japan
        • Kinki University
      • Wakayama, Japan, 641-8510
        • Wakayama Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reinforced staple
Endo GIA Reinforced Reload with Tri-Staple technology
Device:Endo GIA Reinforced Reload with Tri-Staple technology

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hiroki Yamaue, M.D., Ph.D, Wakayama Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

October 10, 2014

First Submitted That Met QC Criteria

October 16, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 20, 2016

Last Verified

July 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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