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2014-10
2016-07
2016-07
120
NCT02270554
Wakayama Medical University
Wakayama Medical University
INTERVENTIONAL
A Prospective, Multi-center Trial for Reinforced Staple 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.
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.
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-10-10 | N/A | 2016-07-20 |
2014-10-16 | N/A | 2016-07-21 |
2014-10-21 | N/A | 2016-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
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
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of pancreatic fistula grade B/C | Ninety days after operation |
| Secondary Outcome Measures | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
