Bronchoscopic lung mapping using dye and microcoil

Phase 3

• Conditions: Malignant pulmonary tumor (suspected or confirmed)

• Registration Number: JPRN-jRCTs031180099
• Lead Sponsor: Sato Masaaki

Brief Summary

The present study achieved higher successful resection rate with sufficient margins (98.5%) than the primary goal (80%) set based on the result of previous studies, although the targeted lesions in this study was deeply located and highly challenging compared with those of previous studies. Furthermore, there was no clinically significant adverse events associated with the present technique of VAL-MAP. Taken together, VAL-MAP 2.0 is safe and effective to assist resection of deeply located pulmonary nodules.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Study Completion: 2020-06-18
• Results First Posted: 2021-09-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1) Malignant pulmonary tumor (suspected or confirmed) that necessitates resection lines other than usual interlobar fissure
2) Corresponds to both 2-1 and 2-2
2-1) A pulmonary lesion or lesions that is anticipated to be hardly identifiable during surgery and necessitate careful determination of resection lines to obtain sufficient resection margins
2-2) A pulmonary lesion or lesions which the use of microcoil is considered to advantageous
3) Consent obtained from the patient

Exclusion Criteria

1) Allergic to platinum
2) Allergic to indigo carmine
3) Anticipated difficulty in intra-airway placement of the microcoil
4) Pregnant women
5) Those who are difficult to obtain Informed Consent from or those aged less than 20 years old
6) Bronchoscopy and/or marking procedure is not feasible due to complications
7) Anatomy precludes successful resection defined in this study
8) Other reasons that are judged to be appropriate by a participating surgeon/physician in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful resection of pulmonary lesions with sufficient resection margins

Secondary Outcome Measures

Name	Time	Method
Efficacy of lung mappings utilizing microcoil<br>Efficacy of mapping-assisted surgery <br>Safety