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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Device:Endo GIA Reinforced Reload with Tri-Staple technology
Kansai Rosai Hospital
Amagasaki, Hyogo, Japan
Kansai Medical University
Hirakata, Osaka, Japan
Hiroshima University
Hiroshima, Hiroshima, Japan
Nara Medical University
Kashihara, Nara, Japan
Incidence of pancreatic fistula grade B/C
Time frame: Ninety days after operation
Incidence of pancreatic fistula defined by ISGPF classification
Time frame: Ninety days after operation
Incidence of pancreatic fistula grade C defined by ISGPF classification
Time frame: Ninety days after operation
Incidence of intraabdominal bleeding
Time frame: Ninety days after operation
Morbidity
Time frame: Ninety days after operation
Mortality
Time frame: Ninety days after operation
Postoperative hospital stay
Time frame: Ninety days after operation
Hemostasis condition of staple line
Time frame: during operation
Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line
Time frame: during operation
Period of drain insertion
Time frame: Ninety days after operation
Damage of pancreatic stump
Time frame: during operation
Frequency of additional suture of pancreatic stump
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Kobe University
Kobe, Hyogo, Japan
Kyoto Prefectural University of Medicine
Kyoto, Japan
Nagoya University
Nagoya, Aichi, Japan
Hyogo College of Medicine
Nishinomiya, Hyogo, Japan
Osaka University
Osaka, Japan
Kinki University
Sayama, Osaka, Japan
...and 1 more locations
Time frame: during operation
Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma
Time frame: Ninety days after operation