Unique ID issued by UMIN | UMIN000015384 |
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Receipt number | R000017893 |
Scientific Title | A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload with Tri-Staple technology during Distal Pancreatectomy |
Date of disclosure of the study information | 2014/10/16 |
Last modified on | 2016/07/19 22:32:47 |
A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload with Tri-Staple technology during Distal Pancreatectomy
A Prospective, Multi-center Investigation of the Endo GIA Reinforced Reload with Tri-Staple technology during Distal Pancreatectomy
A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload with Tri-Staple technology during Distal Pancreatectomy
A Prospective, Multi-center Investigation of the Endo GIA Reinforced Reload with Tri-Staple technology during Distal Pancreatectomy
Japan |
disease of pancreatic body and tail
Hepato-biliary-pancreatic surgery |
Malignancy
NO
To evaluate the impact of the Endo GIA Reinforced Reload with Tri-Staple technology during distal pancreatectomy
Safety,Efficacy
Confirmatory
Pragmatic
Incidence of pancreatic fistula grade B and grade C defined by International Study Group of Postoperative Pancreatic Fistula(ISGPF)
1.Incidence of pancreatic fistula defined by ISGPF classification
2.Incidence of pancreatic fistula grade C defined by ISGPF classification
3.Incidence ofintraabdominal bleeding
4.Morbidity
5.Mortality
6.Postoperative hospital stay
7.Hemostasis condition of staple line
8.Malformationof staple line
9.Period of drain insertion
10.Damage of pancreatic stump
11.Frequency of additional suture of pancreatic stump
12.Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Device,equipment |
the Endo GIA Reinforced Reload with Tri-Staple technology
20 | years-old | <= |
Not applicable |
Male and Female
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
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) Others, patients who are unfit for the study as determined by the attending physician
120
1st name | |
Middle name | |
Last name | Hiroki Yamaue |
Wakayama Medical University
Second Department of Surgery
811-1 Kimiidera, Wakayama, Japan
073-441-0613
yamaue-h@wakayaam-med.ac.jp
1st name | |
Middle name | |
Last name | Manabu Kawai |
Wakayama Medical University
Second Department of Surgery
811-1 Kimiidera, Wakayama, Japan
073-441-0613
kawai@wakayaam-med.ac.jp
Second Department of Surgery, Wakayama Medical University
Second Department of Surgery, Wakayama Medical University
Self funding
1. Department of Gastroenterological Surgery, Osaka University
2. Department of Surgery, Kansai Medical University
3.Department of Surgery, Kansai Rosai Hospital
4.Department of Surgery, Kyoto Prefectural University of Medicine
5.Department of Surgery, Kinki University
6.Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine
7.Department of Surgery, Nara Medical University
8.Second Department of Surgery, Nagoya University
9.Department of HPB Surgery, Hyogo College of Medicine
10.Department of Surgery, Hiroshima University
NO
2014 | Year | 10 | Month | 16 | Day |
Unpublished
Completed
2014 | Year | 09 | Month | 02 | Day |
2014 | Year | 10 | Month | 16 | Day |
2015 | Year | 08 | Month | 14 | Day |
2014 | Year | 10 | Month | 09 | Day |
2016 | Year | 07 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017893
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