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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 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000015384
Enrollment
120
Registered
2014-10-16
Start date
2014-10-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

disease of pancreatic body and tail

Interventions

Sponsors

Second Department of Surgery, Wakayama Medical University
Lead Sponsor
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.Depar
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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

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) Others, patients who are unfit for the study as determined by the attending physician

Design outcomes

Primary

MeasureTime frame
Incidence of pancreatic fistula grade B and grade C defined by International Study Group of Postoperative Pancreatic Fistula(ISGPF)

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactManabu Kawai

Wakayama Medical University Second Department of Surgery

kawai@wakayaam-med.ac.jp073-441-0613

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026