- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02270554
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
Status
Completed
Conditions
Intervention / Treatment
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
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Nagoya, Aichi, Japan
- Nagoya University
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Nishinomiya, Hyogo, Japan
- Hyogo College of Medicine
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Osaka, Japan
- Osaka University
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Sayama, Osaka, Japan
- Kinki University
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Wakayama, Japan, 641-8510
- Wakayama Medical University
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-
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:
- 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
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DP-Study 1401
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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