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A Study of the Efficacy of Aerosolized Indigocarmine and Indocyanine Green in Intraoperative Pulmonary Fistula Site Identification

An Open-Label Stratified Block Randomized Comparative Study of the Efficacy and Safety of Aerosolized Indigocarmine and Indocyanine Green in Intraoperative Pulmonary Fistula Site Identification

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031250320
Enrollment
60
Registered
2025-08-28
Start date
2025-11-25
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

thoracoscopic pneumonectomy thoracoscopic pneumonectomy

Interventions

The patients will be assigned to dye test group or water seal test group by randomization. In the dye test group, an IDC (indigocarmine) inhalation test will be performed, followed by an ICG (indocyan

Sponsors

Kinoshita Tomonari
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients undergoing thoracoscopic lung resection who meet all of the following selection criteria 1) Age:18 years of age or older at the time consent is obtained. 2)Gender: Any gender 3)Patients who have been fully informed of the study and who have given written consent of their own free will based on a thorough understanding of the study 4)Persons who are able to make outpatient visits in accordance with the research schedule.

Exclusion criteria

Exclusion criteria: Patients who meet at least one of the following exclusion criteria will be excluded. 1) Patients with a history of serious drug allergy or serious adverse drug reactions such as anaphylactic shock (especially those with a history of allergy to iodine-containing drugs) 2) Pregnant, possibly pregnant, or lactating mothers. 3) Patients undergoing surgery while taking antiplatelet agents or anticoagulants (4) Patients with serious systemic diseases (5) Patients with severely impaired respiratory function on preoperative pulmonary function tests, making the surgery itself a risk. (6) Patients with active infectious diseases (tuberculosis, pneumonia, etc.) (7) Patients with airway obstructive lesions or asthma under treatment, which is considered difficult to be evaluated by dye inhalation. (8) Other patients who are deemed inappropriate to participate in this study by the principal investigator (co-investigator).

Design outcomes

Primary

MeasureTime frame
Comparison of postoperative leakage volume

Secondary

MeasureTime frame
(1) Comparison of the number of days from postoperative to drain removal (2) Comparison of the number of days from postoperative to discharge date (3) Difference in detection rate of pulmonary fistula site between IDC and ICG

Contacts

Public ContactTomonari Kinoshita

The Jikei University Hospital

t.kinoshita@jikei.ac.jp+81-334331111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026