Esophageal CancerNEIENCT01170845
Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy
A study testing sivelestat sodium hydrate in people with Esophageal Cancer, run by Yokohama City University Medical Center at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 77 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- sivelestat sodium hydrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2007to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Thoracic esophageal squamous cell carcinoma
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of 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.
Read the detailed description
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.
- Conditions
- Esophageal Cancer
- Being tested
- sivelestat sodium hydrate
- Keywords
- Esophagectomy, Postoperative respiratory complications, neutrophil elastase inhibitor
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sivelestat sodium hydrateDrug
Also called Elaspol
saline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Patients in the control group received saline for 7 days starting at the beginning of surgery Receives: 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 Receives: Drug: sivelestat sodium hydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function
the arterial oxygen pressure
Measured: 9 days
Secondary outcomes (2)
Pulmonary function
fraction of inspired oxygen ratio (PF ratio)
Measured: 9 days
Pulmonary function
the duration of mechanical ventilation
Measured: 9 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startMar 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yokohama City University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Chikara Kunisaki, MD,PhD, Study chair, Yokohama City University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170845
- Sponsor's protocol ID
- 531
- Acronym
- NEIE
- Status last verified
- Mar 2007
- First submitted
- 23 Jul 2010
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21557207
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Effect of Neutrophil Elastase Inhibitor on Lung Injury After Esophagectomy
- ClinicalTrials.gov ID
- NCT01170845
- Acronym / sponsor ID
- NEIE / 531
- Conditions
- Esophageal Cancer
- Keywords
- Esophagectomy, Postoperative respiratory complications, neutrophil elastase inhibitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Yokohama City University Medical CenterUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 27 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: sivelestat sodium hydratePatients in the control group received saline for 7 days starting at the beginning of surgery |
| S group | Active comparator | Drug: sivelestat sodium hydratePatients in the S group received sivelestat sodium hydrate at a dosage 4.8mg/kg/day for 7 days starting at the beginning of surgery |
Who may qualify
- Ages
- 55 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Thoracic esophageal squamous cell carcinoma
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sivelestat sodium hydrateAlso: Elaspolsaline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery | Drug | Control group, S group |
Primary outcome
Pulmonary function
Time frame: 9 days
the arterial oxygen pressure
2 secondary outcomes
Pulmonary function
Time frame: 9 days
Pulmonary function
Time frame: 9 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2010.
- Derived from this study: PubMed 21557207Makino 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chikara Kunisaki, MD,PhD study chair
Yokohama City University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sivelestat sodium hydrate in people with Esophageal Cancer, run by Yokohama City University Medical Center at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function (time frame: 9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01170845, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2010.