Table 4.
Clinical trials on VATS combined with ablation hybrid surgery
| PI | research period | Number of samples/cases | Main observational indicators | Subobservable indicators | Unique inclusion and exclusion criteria for projects | Shared inclusion criteria | Shared exclusion criteria | Reporting unit | Research numbers |
|---|---|---|---|---|---|---|---|---|---|
| Chuan Huang | 2022.6.1–2024.12.31 | 50 | Surgical feasibility, perioperative safety (complications), postoperative quality of life, oncological outcomes | – | ∗∗Inclusion Criteria: Age ≥65 years old; |
1. Age ≥18 years old. 2. Clinical diagnosis of synchronous MPLC according to the Martini-Melamed criteria; 3. patient can tolerate hybrid surgery according to MDT assessment 4. Lung tumor is resectable 5. Subjects voluntarily participate in the study and sign the written informed consent form at. |
1. bronchoscopy cannot reach the minor lesion 2. Large blood vessels are within 2 mm or less from the contralateral minor lesion. 3. Patient cannot tolerate bronchoscopy 4. Any comorbidity that the investigator feels would interfere with the safety of the subject or the evaluation of study objectives 5. Pregnant or breast feeding. 6. Pacemaker, implantable cardioverter, or another electronic implantable device |
Beijing Hospital | ChiCTR2300069053 |
| Jiayuan Sun | 2020.7–2025.12 | 30 | Objective response rate (ORR) based on mRECIST criteria, assessed up to 1 year | PFS,OS,postoperative complication | ∗∗Inclusion Criteria: (1) Ablation Lesion A is accessible/adjacent to bronchi and the size is ≤3 cm according to HRCT | Shanghai Chest Hospital | NCT04730453 | ||
| Hecheng Li | 2023.2–2025.12 | 172(86 + 86) | Perioperative complication rate | ORR,Perioperative surgery-related indicators, lung function, quality of life EORTC QLQ-LC29,economic cost,DFS |
∗∗Inclusion Criteria: (1) Age ≥18 years and ≤80 years; (2) Bilateral simultaneous MPLC diagnosed by HRCT; (3) At least one minor lesion (6 mm ≤ diameter ≤20 mm, CTR <0.5) is located on the contralateral side of the major lesion and requires treatment after MDT discussion. (4) The ipsilateral minor lesion can be concurrently subjected to sublung lobectomy (5) ECOG PS score of 0–1 ∗∗Exclusion criteria: (1) Large blood vessels are present within 2 mm from the contralateral minor lesion. |
Ruijin Hospital | NCT05662553 | ||
| Walter J. Scott (Criteria not publicly available) | 2002.6–2004.2 | 20 | – | – | ∗∗Inclusion Criteria: (1) Diagnosis of malignant non-small cell lung cancer (NSCLC). (2) Intraoperative needle biopsy confirmation allowed.(3)All tissue to be treated by radiofrequency tumor ablation must be completely contained within boundaries of planned lung resection | Fox Chase Cancer Center | NCT00039507 | ||
| Jason A Beattie (Surgical pathology is only used to assess the effectiveness of ablation) | 2022.6.1–2025.6.30 | 10 | (1) Rate of planned ablations(Day 1) (2) Pathological changes in the tumor tissue: The % necrosis, % viable tumor, and % stroma/inflammation present in the targeted nodules after ablation(4 weeks). |
(1) Histological changes in lung tissue outside the zone of predicted ablation: The % necrosis and of % stroma/inflammation will be described. (2) Immune-histochemical changes in the tumor tissue: Immune-histochemical evaluation including TTF-1, Napsin-A, p40, or other immune-histochemical assessments will be performed if needed on a per case basis. |
∗∗Inclusion Criteria: (1) Subject with Stage I - II primary lung cancer (Solitary nodules up to 3 cm) as defined by previous pathology or ROSE. (2) Pathological proof of target nodule/tumor type and malignancy. (3) Target nodule/tumor which can be accessed via bronchoscopy and confirmed location with cone beam CT scan intraoperatively ∗∗Exclusion criteria: (1) Target nodule <1.0 cm. (2) Prior radiation or neo adjuvant chemotherapy of the target nodule/tumor. (3) Patients in other therapeutic lung cancer studies. |
Beth Israel Deaconess Medical Center | NCT05281237 | ||
| Philippe L Pereira, Hermann Aebert (Surgical pathology is only used to assess the effectiveness of ablation) | 2004.4–2006.5 | 9 | Rate of incompletely treated tumors | Pathologic tissue changes, rate of major and minor complications | ∗∗Inclusion Criteria: (1) Maximum of 3 lung tumors. (2) Maximum tumor size less than 5 cm. (3) Must be able to receive standard surgery ∗∗Exclusion Criteria: (1) Pathological coagulation tests positive. (2) Maximum tumor size more than 5 cm. (3) Bilateral minor lung cancer with more than 3 tumors. |
University Hospital Tuebingen | NCT00610844 |