ENB-guided Ablation Therapy Combined With VATS in the Treatment of MPLC

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Lung Cancer

Treatments: Procedure: ENB-guided ablation therapy combined with VATS

Study type: Observational

Funder types: Other

Identifiers

NCT04730453

SHCHE202101

Details and patient eligibility

About

The study is designed as a prospective trial whose purpose is to evaluate the effectiveness and safety of ENB-guided ablation therapy combined with VATS in the treatment of multiple primary lung cancers (MPLC).

Full description

Patients will be first screened, and only after meeting all the selection criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive ENB-guided ablation therapy combined with VATS. The primary endpoint is objective response rate (ORR). The secondary endpoints include progression-free survival (PFS), overall survival (OS) and safety.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ minutes old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old.
2. The subject is diagnosed as multiple primary lung cancer via preoperative imaging/pathological examination.
3. Thin-slice CT images show that the ablation Lesion A is accessible/adjacent to bronchi and the size is ≤ 3 cm.
4. The subject with multiple primary lung cancers can be treated with ENB-guided ablation therapy combined with VATS according to multidisciplinary assessment.

Exclusion criteria

1. The subject who cannot tolerate general anesthesia for their cardiopulmonary function, or there are other contraindications, such as uncorrectable coagulopathy.
2. The situation in which the investigators think that the subject is not suitable to participate in this study.