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

Wakayama Medical University

Status and phase: Completed; Phase 2

Conditions: Pancreatic Neoplasms

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02270554

DP-Study 1401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Reinforced staple

Experimental group

Description:

Endo GIA Reinforced Reload with Tri-Staple technology

Treatment:

Device: Endo GIA Reinforced Reload with Tri-Staple technology