se of the fluorescence dye indocyanine green for the evaluation of the healingof the main bronchi after lung transplantatio

Phase 1

Conditions: Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
Anastomotic healing after lung transplantation

Registration Number: EUCTR2016-000888-16-AT

Lead Sponsor: Medical University of Vienna

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

Inclusion Criteria

• age >18
• written informed consent
• lung transplantation at the Division of Thoracic Surgery, Medical University of Vienna
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• age >70
• participation in other clinical studies
• pregnancy
• renal or hepatic failure
• previous reactions to ICG or iodide
• hyperthyroidism
• active haematological disease

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Anastomotic complications state a serious problem after lung<br>transplantation. However, conventional bronchoscopy is the only<br>available modality to directly observe the perfusion of the anastomotic<br>site. Aim of this study is to show that the procedure of ICG<br>bronchoscopy is feasible. In the future, ICG bronchoscopy might help to<br>identify patients with impaired perfusion at the anastomotic site earlier<br>and guide the surgeon in the further management of such patients.;Secondary Objective: Not applicable;Primary end point(s): Measurable ICG fluorescence at the anastomotic site intra-operative,<br>3-9 days postoperative (before extubation) and 2-3 months postoperative.;Timepoint(s) of evaluation of this end point: As it is a feasibility study, evaluation of data will not commence until<br>the last patient has finished the follow-up examinations

Secondary Outcome Measures