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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02270554

Enrollment

120

Registered

2014-10-21

Start date

2014-10-31

Completion date

2016-07-31

Last updated

2016-07-21

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

Conditions

Pancreatic Neoplasms

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.

Interventions

DEVICEEndo GIA Reinforced Reload with Tri-Staple technology

Device:Endo GIA Reinforced Reload with Tri-Staple technology

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of pancreatic fistula grade B/C	Ninety days after operation

Secondary

Measure	Time frame
Incidence of pancreatic fistula grade C defined by ISGPF classification	Ninety days after operation
Incidence of intraabdominal bleeding	Ninety days after operation
Morbidity	Ninety days after operation
Mortality	Ninety days after operation
Postoperative hospital stay	Ninety days after operation
Incidence of pancreatic fistula defined by ISGPF classification	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
Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma	Ninety days after operation
Hemostasis condition of staple line	during operation

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026