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

Phase 2

Completed

• Conditions: Pancreatic Neoplasms
• Interventions: Device: Endo GIA Reinforced Reload with Tri-Staple technology

• Registration Number: NCT02270554
• Lead Sponsor: Wakayama Medical University

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 prospective, multi-center trial.

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 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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-10
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-21
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reinforced staple	Endo GIA Reinforced Reload with Tri-Staple technology	Endo GIA Reinforced Reload with Tri-Staple technology

Primary Outcome Measures

Name	Time	Method
Incidence of pancreatic fistula grade B/C	Ninety days after operation

Secondary Outcome Measures

Name	Time	Method
Morbidity	Ninety days after operation
Mortality	Ninety days after operation
Hemostasis condition of staple line	during operation
Incidence of pancreatic fistula defined by ISGPF classification	Ninety days after operation
Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma	Ninety days after operation
Incidence of pancreatic fistula grade C defined by ISGPF classification	Ninety days after operation
Incidence of intraabdominal bleeding	Ninety days after operation
Postoperative hospital stay	Ninety days after operation
Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line	during operation
Period of drain insertion	Ninety days after operation
Damage of pancreatic stump	during operation
Frequency of additional suture of pancreatic stump	during operation

Trial Locations

Locations (11)

Hiroshima University; 🇯🇵 Hiroshima, Hiroshima, Japan

Nagoya University; 🇯🇵 Nagoya, Aichi, Japan

Kansai Rosai Hospital; 🇯🇵 Amagasaki, Hyogo, Japan

Nara Medical University; 🇯🇵 Kashihara, Nara, Japan

Kyoto Prefectural University of Medicine; 🇯🇵 Kyoto, Japan

Hyogo College of Medicine; 🇯🇵 Nishinomiya, Hyogo, Japan

Kobe University; 🇯🇵 Kobe, Hyogo, Japan

Kansai Medical University; 🇯🇵 Hirakata, Osaka, Japan

Osaka University; 🇯🇵 Osaka, Japan

Wakayama Medical University; 🇯🇵 Wakayama, Japan

Kinki University; 🇯🇵 Sayama, Osaka, Japan