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Completed

NCT Number: NCT02270554

A Prospective, Multi-center Trial for Reinforced Staple During 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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Kansai Rosai Hospital, Amagasaki, Hyogo, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Endo GIA Reinforced Reload with Tri-Staple technology

Device

Device:Endo GIA Reinforced Reload with Tri-Staple technology

Primary outcomes

  1. Incidence of pancreatic fistula grade B/C

    Time frame: Ninety days after operation

Secondary outcomes

  1. Incidence of pancreatic fistula defined by ISGPF classification

    Time frame: Ninety days after operation

  2. Incidence of pancreatic fistula grade C defined by ISGPF classification

    Time frame: Ninety days after operation

  3. Incidence of intraabdominal bleeding

    Time frame: Ninety days after operation

  4. Morbidity

    Time frame: Ninety days after operation

  5. Mortality

    Time frame: Ninety days after operation

  6. Postoperative hospital stay

    Time frame: Ninety days after operation

  7. Hemostasis condition of staple line

    Time frame: during operation

  8. Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line Malformationof staple line

    Time frame: during operation

  9. Period of drain insertion

    Time frame: Ninety days after operation

  10. Damage of pancreatic stump

    Time frame: during operation

  11. Frequency of additional suture of pancreatic stump

    Time frame: during operation

  12. Incidence of pancreatic fistula stratified based on thickness of pancreas parenchyma

    Time frame: Ninety days after operation

Sponsors and collaborators

Lead sponsor

Wakayama Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 21, 2014
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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