NCT01170845

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
Last Updated

July 27, 2010

Status Verified

March 1, 2007

Enrollment Period

2 years

First QC Date

July 23, 2010

Last Update Submit

July 26, 2010

Conditions

Esophageal Cancer

Keywords

EsophagectomyPostoperative respiratory complicationsneutrophil elastase inhibitor

Outcome Measures

Primary Outcomes (1)

  • Pulmonary function

    the arterial oxygen pressure

    9 days

Secondary Outcomes (2)

  • Pulmonary function

    9 days

  • Pulmonary function

    9 days

Study Arms (2)

Control group

PLACEBO COMPARATOR

Patients in the control group received saline for 7 days starting at the beginning of surgery

Drug: sivelestat sodium hydrate

S group

ACTIVE COMPARATOR

Patients in the S group received sivelestat sodium hydrate at a dosage 4.8mg/kg/day for 7 days starting at the beginning of surgery

Drug: sivelestat sodium hydrate

Interventions

sivelestat sodium hydrateDRUG

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

Also known as: Elaspol
Control groupS group

Eligibility Criteria

Age55 Years - 77 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Thoracic esophageal squamous cell carcinoma

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chikara Kunisaki

Yokohama, Kanagawa, 232-0024, Japan

Location

Related Publications (1)

  • Makino H, Kunisaki C, Kosaka T, Akiyama H, Morita S, Endo I. Perioperative use of a neutrophil elastase inhibitor in video-assisted thoracoscopic oesophagectomy for cancer. Br J Surg. 2011 Jul;98(7):975-82. doi: 10.1002/bjs.7499. Epub 2011 May 9.

    PMID: 21557207DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Chikara Kunisaki, MD,PhD

    Yokohama City University Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2010

First Posted

July 27, 2010

Study Start

March 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

July 27, 2010

Record last verified: 2007-03

Locations

JP(1)