Esophagectomy is the surgical removal of all or part of the esophagus. The patients enrolled in the study will undergo this surgery for treatment of esophageal cancer. The condition under investigation is the postoperative inflammatory syndrome (SIRS) after esophagectomy.
Conditions
Interventions
Product Name: Elafin
Product Code: Elafin
Pharmaceutical Form: Solution for infusion
CAS Number: 82 0211-82-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
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Sponsors
Proteo Biotech AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subject has carcinoma of the esophagus that will be treated with esophagectomy 2.Subject is informed and given ample time and opportunity to think about his participation and has given his written informed consent. 3.Subject is willing and able to comply with all trial requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Less than 18 years of age 2.Child-bearing potential 3.Participation in another trial with an investigational product within the last 4 weeks 4.White blood cell count 12,000 cells/mm³ 6.Greater than 10% immature neutrophils 7.Body temperature > 38°C 8.Body temperature 90 bpm at eligibility 10.Serum creatinine > 2.0 mg/dL 11.Severe chronic liver disease 12.Severe central nervous system or severe psychiatric disease 13.Impaired spontaneous ventilation 14.Acute myocardial infarction within the last 6 weeks 15.Known heart failure, NYHA Classification III or IV 16.Active infection requiring systemic administration of antibiotics 17.Previous bone marrow transplant 18.Previous organ transplant (heart, kidney, liver) 19.Current immunosuppressive therapy such as cortisone, cyclosporine or azothioprine 20.Cancer-related chemotherapy within the last 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparasion of the increase of serum IL-6 concentrations at 2 h postoperatively between the treatment group and the placebo group;Secondary Objective: Comparasion of the time-courses of serum levels of IL-6, IL-8, IL-10, IL-1ß, TNFa and C-reactive protein (CRP) between the treatment group and the placebo group, both in terms of absolute values and values relative to preoperative baseline levels.;Primary end point(s): The investigator has to withdraw a subject from the trial in the following cases: 1.Occurrence of an AE that does not justify a continuation in the trial 2.Impossibility to obtain samples 3.Protocol deviation that may jeopardize the performance of the trial | — |
Countries
Germany
Outcome results
None listed