A Prospective, Multi-center Trial for Reinforced Staple During Distal Pancreatectomy

Pancreatic Neoplasms Clinical Trial

Official title:

A Prospective, Multi-center Investigation of Impact of the Endo GIA Reinforced Reload With Tri-Staple Technology During Distal Pancreatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270554
• Other study ID #: DP-Study 1401
• Status: Completed
• Phase: Phase 2
• First received: October 10, 2014
• Last updated: July 20, 2016
• Start date: October 2014
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Wakayama Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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 prospective, multi-center trial.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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:

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. Patients who are unfit for the study as determined by the attending physician

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Device:
• Endo GIA Reinforced Reload with Tri-Staple technology
Device:Endo GIA Reinforced Reload with Tri-Staple technology

Locations

Country	Name	City	State
Japan	Kansai Rosai Hospital	Amagasaki, Hyogo
Japan	Kansai Medical University	Hirakata, Osaka
Japan	Hiroshima University	Hiroshima, Hiroshima
Japan	Nara Medical University	Kashihara, Nara
Japan	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	Wakayama Medical University	Wakayama

Sponsors (1)

Lead Sponsor	Collaborator
Wakayama Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pancreatic fistula grade B/C		Ninety days after operation	No
Secondary	Incidence of pancreatic fistula defined by ISGPF classification		Ninety days after operation	No
Secondary	Incidence of pancreatic fistula grade C defined by ISGPF classification		Ninety days after operation	No
Secondary	Incidence of intraabdominal bleeding		Ninety days after operation	No
Secondary	Morbidity		Ninety days after operation	No
Secondary	Mortality		Ninety days after operation	No
Secondary	Postoperative hospital stay		Ninety days after operation	No
Secondary	Hemostasis condition of staple line		during operation	No
Secondary	Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line		during operation	No
Secondary	Period of drain insertion		Ninety days after operation	No
Secondary	Damage of pancreatic stump		during operation	No
Secondary	Frequency of additional suture of pancreatic stump		during operation	No
Secondary	Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma		Ninety days after operation	No