Clinical trial NCT04730453: ENB-guided Ablation Therapy Combined With VATS in the Treatment of MPLC
Official title: Electromagnetic Navigation Bronchoscopy Guided Ablation Therapy Combined With VATS in the Treatment of Multiple Primary Lung Cancers
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: Electromagnetic Navigation Bronchoscopy (ENB)
Video-Assisted Thoracic Surgery (VATS)
Multiple Primary Lung Cancers (MPLC)
Ablation Therapy
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2021-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who meet inclusion/exclusion will be enrolled in the study consecutively.

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of ablation efficacy, ORR (objective response rate)
timeFrame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years.
Secondary outcomes:
measure: Evaluation of ablation efficacy, PFS (progression-free survival)
timeFrame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years.
measure: Evaluation of ablation efficacy, OS (overall survival)
timeFrame: From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
measure: Observation of complications of ablation
timeFrame: From date of treatment to the one month after ablation.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Jiayuan Sun, MD, PhD
role: STUDY_DIRECTOR
References:
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