An open randomised, prospective, multi-centre, parallel-group trial to compare efficacy and safety of TachoSil versus standard surgical treatment in patients undergoing pulmonary lobectomy for lung malingnancy and requiring treatment for air leakage. - TachoSil versus standard surgical treatment for air leakage in pulmonary lobectomy
- Conditions
- Management of pulmonary air leakage following lobectomy in subjects with lung malignancies including metastases.MedDRA version: 8.1Level: PTClassification code 10024741
- Registration Number
- EUCTR2004-002380-24-AT
- Lead Sponsor
- ycomed Danmark ApS, International Medical Affairs
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
Pre-operative:
Informed consent obtained, 18 years of age or above, planned elective lobectomy for lung malingnancy with intrapulmonary lymphadenectomy (with antero- or postero-lateral incision), use of adequate contraception for females.
After pulmonary lobectomy:
Air leakage of grade 1 or 2
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
Pre-operative:
Previous lung surgery; anti-tumour chemotherapy within last 3 weeks; radiotherapy for lung malingnancy within last 4 weeks; allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin; emergency surgery, FEV1 (forced expiratory volume) < 40%; previousely exposure to TachoComb, TachoComb H or TachoSil; present abuse of drug or alcohol, participation in any other trial with an investigational drug or device within 30 days prior to inclusion, participation or planned praticipation in another trial during the trial period; positive pregnancy test (females) and breastfeeding (females).
After pulmonary lobectomy:
Serious complications including need for surgical adhesiolysis of the remaining lung tissue, pneumonectomy, additional wedge resection of the lung, use of any fibrin sealant (including TachoSil) before randomisation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare sealing efficacy and safety of TachoSil versus standard surgical treatment as secondary management of intra-operative pulmonary air leakage after lobectomy in subjects with lung malignancies including metastases. ;Secondary Objective: ;Primary end point(s): Duration of post-operative air leakage.<br>
- Secondary Outcome Measures
Name Time Method