Use of the fluorecent dye indocyanine green for the evaluation of the blood flow in the wind pipe after surgery

Bronchoscopic indocyanine green fluorescence imaging for the evaluation of tracheal perfusion after surgery

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001725-10-AT

Enrollment

Unknown

Registered

2013-12-30

Start date

2014-01-24

Completion date

Unknown

Last updated

2017-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheal stenosis secondary to malign and benign conditions

Interventions

Trade Name: ICG-PULSION-Pulver zur Herstellung einer Injektionslösung Product Name: Indocyanine green (ICG) Pharmaceutical Form: Powder for injection INN or Proposed INN: INDOCYANINE GREEN CAS Number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • age >18 • written informed consent • elective tracheal resection 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 17 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

Exclusion criteria: • age >80 • participation in other clinical studies • pregnancy • renal or hepatic failure • previous tracheal surgery • previous reactions to ICG or iodide • hyper-/hypothyroidism • active hematological disease

Design outcomes

Primary

Measure	Time frame
Main Objective: Anastomotic complications state a serious problem in tracheal surgery. However, conventional bronchoscopy is the only available modality to directly observe the perfusion of the anastomotic site. Aim of this study is to show that the procedure of ICG bronchoscopy is feasible. In the future, ICG bronchoscopy might help to identify patients with impaired perfusion at the anastomotic site earlier 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, 3-5 days postoperative and 2 months postoperative.;Timepoint(s) of evaluation of this end point: As it is a feasibility study, evaluation of data will not commence until the last patient has finished the follow-up examinations	—

Measure

Time frame

Main Objective: Anastomotic complications state a serious problem in tracheal surgery. However, conventional bronchoscopy is the only available modality to directly observe the perfusion of the anastomotic site. Aim of this study is to show that the procedure of ICG bronchoscopy is feasible. In the future, ICG bronchoscopy might help to identify patients with impaired perfusion at the anastomotic site earlier 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, 3-5 days postoperative and 2 months postoperative.;Timepoint(s) of evaluation of this end point: As it is a feasibility study, evaluation of data will not commence until the last patient has finished the follow-up examinations

—

Secondary

Measure	Time frame
Secondary end point(s): Non defined.;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Austria

Contacts

Public ContactDepartment für Chirurgie

Medizinische Universität Wien

konrad.hoetzenecker@meduniwien.ac.at00431404006979

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026