Status:
COMPLETED
A Prospective, Multi-center Trial for Reinforced Staple During Distal Pancreatectomy
Lead Sponsor:
Wakayama Medical University
Conditions:
Pancreatic Neoplasms
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
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 prospect...
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 pancreate...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02270554
Start Date
October 1 2014
End Date
July 1 2016
Last Update
July 21 2016
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Kansai Rosai Hospital
Amagasaki, Hyogo, Japan
2
Kansai Medical University
Hirakata, Osaka, Japan
3
Hiroshima University
Hiroshima, Hiroshima, Japan
4
Nara Medical University
Kashihara, Nara, Japan