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Effect of virtual-assisted lung mapping with indigo carmine and indocyanine green in sublobar lung resection

Effect of virtual-assisted lung mapping with indigo carmine and indocyanine green in sublobar lung resection

48

Number of cases for analysis (48 cases) Sex 27 male/21 female Age (years), median (range) 66 (36-84) Height (cm), median (range) 164 cm (138 cm-182 cm)W eight (kg), median (range) 62 kg (36 kg-96 kg) Smoking index, pack-year 13 (0-54) Surgical procedure 46 thoracoscopic / 2 robotic

Mar 02, 2023: Start of study (jRCT publication date) May 10, 2023: Start of enrollment (date of first case registration) December 26, 2024: Enrollment completed (no enrollment errors, duplicate enrollments, or other enrollment problems) January 26, 2025: End of observation period for all study subjects March 13, 2025: Database fixed

The incidence of perioperative complications was 6.3% (3/48 patients; Clopper-Pearson 95% confidence interval: 1.3%-17.2%). Of these, there were no cases of serious illness and no cases of illness leading to discontinuation of the study. There were no cases of high incidence of illness, and none of the illnesses were new, as they had already been reported. The incidence of bronchoscopy-related adverse events was 4.2% (2/48 patients; Clopper-Pearson 95% confidence interval: 0.5%-14.3%). Of these, there were no cases of serious illness, and no cases of illness that led to discontinuation of the study. There were no cases of high incidence of illness, and none of the illnesses were new, as they had already been reported.

Primary endpoint: In total, 158 markings were performed for 51 lesions. 155 of the 158 markings were confirmed intraoperatively for a success rate of 98.1% (Clopper-Pearson 95% confidence interval 94.6%-99.6%), indicating superiority of indigocarmine. The results for PPS were similar to those of the FAS. Secondary Endpoints: Unsuccessful resection was defined if tumors were not included in the resected specimen, requiring additional resection or a change of surgery, or if tumors were not confirmed on postoperative pathology. The percentage of successful resections was evaluated by defining cases other than unsuccessful resections. Of the 51 lesions resected, 48 were successfully resected. The resection success rate was 94.1% (Clopper-Pearson 95% confidence interval 83.8%-98.8%).

In this study, 48 study subjects received the study drug (a total of 158 markings were performed). The primary endpoint of a 98% marking success rate confirmed the superiority of bronchoscopic lung marking with indigocarmine plus indocyanine green over indigocarmine alone (no indocyanine green) as a preoperative bronchoscopic marking method.

Sept. 30, 2025

No

none

https://jrct.mhlw.go.jp/latest-detail/jRCTs031220668

Sato Masaaki

The University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku, Tokyo

satom-sur@h.u-tokyo.ac.jp

Nagano Masaaki

The University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku, Tokyo

+81-338155411

masaaki.1125@gmail.com

Complete

Mar. 02, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) With suspected or diagnosed lung cancer, who require lung resection other than standard lobectomy
(2) With lesions which are predicted to be difficult to identify and require careful determination of resection lines to obtain sufficient resection margins in surgery:
A) Difficult to identify due to the characteristics of the lesions
B) Difficult to identify due to the condition of the lung
C) Judged to need lung mapping by clinical investigators due to other reasons
(3) Aged 18 years and above at the time of informed consent is taken
(4) Male or female
(5) Able and willing to give written informed consent with sufficient understanding after having received sufficient explanation

(1) With allergy to iodine contrast
(2) Having a history of asthma
(3) Having a history of allergy to indocyanine green or indigo carmine
(4) Having a history of severe drug allergy or severe side effects
(5) Judged as ineligible by clinical investigators

Both

lung cancer

Off-label use of indocyanine green with indigo carmine for bronchoscope marking before surgery of lung cancer

bronchoscope marking

indocyanine green

Rate of successful markings

(1) Rate of successful resections
(2) Incidence of perioperative complications
(3) Incidence of adverse events

+81-358410818

Feb. 26, 2023

None