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Completed

NCT Number: NCT01170845

Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy

A neutrophil elastase inhibitor may have effect on suppression of the lung injury after thoransthoracic esophagectomy. The investigators hypothesized that postoperative complication, particularly respiratory complication may be reduced by neutrophil elastase inhibitor after esophagectomy.

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Key information

Conditions

Esophageal Cancer Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

55 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chikara Kunisaki

Yokohama, Kanagawa, 232-0024, Japan

About this study

The aim of this study was to clarify the usefulness of perioperative administration of sivelestat sodium hydrate, a selective inhibitor of neutrophil elastase in the pulmonary function, systemic inflammatory response, and the postoperative clinical course following video-assisted thoracoscopic esohpagectomy for esophageal cancer.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Thoracic esophageal squamous cell carcinoma

Exclusion criteria

  • Preoperative chemoradiotherapy
  • Cardiovascular disease with NYHA grade III or IV
  • Pulmonary disorder with Hugh-Jones classification II, III, IV, or V, preo
  • Liver cirrhosis
  • Renal failure

Treatment and study plan

sivelestat sodium hydrate

Drug

saline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery

Other names: Elaspol

Primary outcomes

  1. Pulmonary function

    Time frame: 9 days

    the arterial oxygen pressure

Secondary outcomes

  1. Pulmonary function

    Time frame: 9 days

    fraction of inspired oxygen ratio (PF ratio)

  2. Pulmonary function

    Time frame: 9 days

    the duration of mechanical ventilation

Sponsors and collaborators

Lead sponsor

Yokohama City University Medical Center

Other

Registry information

Official study title

A Pilot Study of Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy

Acronym: NEIE

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jul 27, 2010
Registry last updated
Jul 27, 2010

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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