Mid-term efficacy and safety of transbronchial cryoablation for stage IA peripheral lung cancer: a retrospective analysis

Introduction

Lung cancer remains the most prevalent and deadly cancer worldwide (1,2). With the aging population and the widespread computed tomography (CT) screening, there is a growing number of patients diagnosed with early-stage or multiple primary lung cancers who are unsuitable or refuse surgery, due to comorbidities, compromised pulmonary function, or high surgical risk (3,4). For patients who are ineligible or unwilling to receive surgery, ablation therapy may be an alternative therapeutic option (5-8).

Cryoablation can induce tumor cell death through several mechanism. First, rapid temperature decrease in the central zone of cryoablation results in the formation of extracellular ice, which leads to the extracellular hypertonic environment, osmotic cellular shrinkage and further cell death. At the vascular level, endothelial injury causes microthrombosis and ischemic necrosis within the ablation zone. Furthermore, cryoablation triggers immunogenic cell death, releasing damage-associated molecular patterns (DAMPs) that may stimulate anti-tumor immune responses (9-11). Compared with heating modalities, cryoablation may offer better tolerability and a superior safety profile (12). Moreover, cryoablation may stimulate a greater immune response (13,14).

However, percutaneous ablation has been associated with significant complications (15). Transbronchial ablation represents a promising alternative that may reduce the incidence of severe complications (16). To date, several transbronchial thermal ablation catheters have been developed with promising safety and efficacy, though evidence is limited by either small-scale or short follow-up period (17-21). We developed a 1.9-mm-diameter flexible cryoablation probe and validated the feasibility of cryoablation guided by navigation bronchoscopy and robotic-assisted bronchoscopy (RAB) for treating peripheral pulmonary lesions for the first time worldwide (22,23). However, previous reports had a relatively short follow-up period. Therefore, we retrospectively collected follow-up data of patients with stage IA peripheral lung cancer who received transbronchial cryoablation. We aimed to evaluate the mid-term efficacy and safety of transbronchial cryoablation in patients with stage IA peripheral lung cancer. To date, this study is the one with the longest follow-up period in the field of transbronchial cryoablation. We present this article in accordance with the STROBE reporting checklist (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-1-0043/rc).

Methods

Patients

This retrospective study included patients with stage IA peripheral lung cancer who received transbronchial cryoablation from September 2022 to October 2025 in Shanghai Chest Hospital. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of Shanghai Chest Hospital (No. IS25234). Due to the retrospective nature of this study and the use of anonymized clinical data, the requirement for informed consent was waived by the Ethics Committee. Some follow-up data (3 months for four lesions; 6–12 months for eight lesions) were reported in earlier publications (22,23). The inclusion criteria were (I) patients aged 18 years or older; (II) clinical stage IA (T1a–1cN0M0) peripheral lung cancer confirmed either pathologically or by multidisciplinary team (MDT) consensus, with a maximum tumor diameter of ≤3 cm according to the eighth edition of the tumor node metastasis (TNM) staging classification (24); (III) patients who provided informed consent for transbronchial cryoablation due to surgical and radiotherapy ineligibility or declination. The exclusion criteria were (I) patients with advanced lung cancer or pulmonary metastases; (II) patients who lost to follow-up after transbronchial cryoablation. Since this study is a retrospective study, no sample size calculation was performed.

Procedure

All patients received thin-slice contrast-enhanced chest CT or positron emission tomography-CT prior to cryoablation for procedural planning. All procedures were performed under general anesthesia using a flexible bronchoscope (BF-1TQ290 or BF-P290; Olympus, Tokyo, Japan) through the endotracheal tube. Electromagnetic navigation bronchoscopy (ENB) (superDimension navigation system, software version 7.0; Medtronic, Minneapolis, MN, USA), virtual bronchoscopic navigation (VBN) (DirectPath; Olympus), or RAB (Ion^TM Endoluminal System; Intuitive Surgical, Sunnyvale, CA, USA) was conducted for navigational assistance. Radial probe endobronchial ultrasound (RP-EBUS) (UM-S20-17S; Olympus) was used for tumor localization and assessment. Cone-beam computed tomography (CBCT) (Cios Spin or Artis Q ceiling; Siemens Healthineers, Erlangen, Germany) was employed to confirm the position of the cryoprobe. All cryoablation procedures were conducted using the Cryotherapy System and a 1.9-mm-diameter flexible cryoprobe [AT-2020-G, Y1908, Y1912; AccuTarget MediPharma (Shanghai) Co., Ltd., Shanghai, China]. Ten minutes freezing time, 3 minutes thaw time, and two to three cycles were recommended for each ablation. Additionally, the specific freezing time and the number of freeze-thaw cycles were determined by the lesion size and were guided by intraoperative real-time CBCT monitoring. If needed, multiple ablations were carried out through different sites for one lesion to obtain better tumor coverage. Immediate post-procedural CBCT was conducted to confirm complete coverage of the target lesion by the ablation zone and to screen for complications such as pneumothorax. All procedures were performed by experienced interventional pulmonologists.

Follow-up

A chest CT scan was performed 24 hours post-ablation to assess immediate complications. After cryoablation, subsequent follow-up chest CT scans were recommended to conduct at 1 month, 3 months, then every 3 months for the first year, every 6 months for the second and third year.

Efficacy evaluation

The primary efficacy endpoint was local progression-free survival (LPFS) rate. The evaluation criteria for LPFS were consistent with previous publications (21,25). The efficacy assessment was conducted by an experienced radiologist. LPFS was defined as the time from cryoablation to local progression.

Safety evaluation

Adverse events during or within 30 days post-procedure were recorded and graded through Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (26). Serious adverse events were defined as events of grade ≥2.

Statistical analysis

Patient and nodule characteristics were summarized using descriptive statistics, presented as frequency (percentage), mean ± standard deviation, or median (range), as appropriate. Data were analyzed through SPSS 24.0 (IBM Corporation, Armonk, NY, USA), and GraphPad Prism 10.1.2 (GraphPad Software, La Jolla, CA, USA). P value <0.05 was considered to indicate statistically significant difference.

Results

Patient and lesion characteristics

A total of 23 patients (24 lesions) with stage IA peripheral lung cancer who underwent 25 transbronchial cryoablation from September 2022 to October 2025 were enrolled. All 25 cryoablation procedures were included in the safety analysis, and 22 lesions with follow-up of at least 3 months were included in the efficacy evaluation. The median age of patients with stage IA peripheral lung cancer was 67.0 years (range, 43–84 years), and the mean tumor size of lesions was 14.2±4.2 mm (range, 7.34–24.68 mm). Additionally, 6 (25.0%) lesions were solid nodules, 14 (58.3%) were mixed ground-glass nodules (mGGNs) and 4 (16.7%) were pure ground-glass nodules (pGGNs). One patient received ablation twice for two different primary tumors. One patient received two ablation procedures for one lesion due to advanced age and the large size of the lesion. All patients underwent ablation because they were unsuitable for or refused surgery and radiotherapy. Of the 24 lesions, 23 were pathologically confirmed through preoperative transbronchial biopsy. The remaining one, identified in a patient with two lesions both deemed malignant by MDT consensus, was treated with cryoablation concurrent with surgical resection of the other lesion in a single session. Among pathologically confirmed tumors, adenocarcinoma was the predominant histological subtype (n=22, 95.7%), with one case of squamous cell carcinoma. VBN was used in 10 (40.0%) procedures, ENB was employed in 5 (20.0%) procedures, and RAB was applied in 10 (40.0%) procedures. Additional information regarding patients with early-stage lung cancer is provided in Table 1.

Efficacy

Of the 24 lesions, 22 were followed-up for more than 3 months and were included in the efficacy analysis. Representative cases of CBCT-guided transbronchial cryoablation for solid nodules and GGNs are shown in Figures 1,2, respectively. The median follow-up was 20.0 months (range, 3–38 months). The median LPFS was not reached, the LPFS rate remained stable at 89.2% throughout the follow-up duration at 1, 2, and 3 years (Figure 3). Among all lesions, two solid nodules demonstrated incomplete ablation at 3 months after cryoablation and further developed local progression at 6 and 9 months post-cryoablation, respectively. One patient underwent repeat ablation upon detection of progression.

Figure 1 A case of patient with solid nodule receiving CBCT-guided transbronchial cryoablation. (A) Pre-procedural CBCT images localized the target lesion. (B) Intraprocedural CBCT images verified the precise positioning of the ablation catheter inside the lesion. (C) Post-ablation CBCT confirmed complete coverage of target lesion by the ablation zone and assessed procedure-related complications. (D-H) CT images obtained at preoperative assessment, 1 day, 1 month, 3 months, and 12 months. CBCT, cone-beam computed tomography; CT, computed tomography.

Figure 2 A case of patient with GGN receiving CBCT-guided transbronchial cryoablation. (A) Pre-procedural CBCT images. (B) Intraprocedural CBCT images. (C) Post-ablation CBCT. (D-J) CT images obtained at preoperative assessment, 1 day, 1 month, 3 months, 6 months, 12 months, and 24 months. CBCT, cone-beam computed tomography; CT, computed tomography; GGN, ground-glass nodule.

Figure 3 Kaplan-Meier survival curve of LPFS. LPFS for stage IA patients. The 1-, 2-, and 3-year LPFS rates remained stable at 89.2%. LPFS, local progression-free survival.

Safety

No perioperative mortality was noted during or within 30 days of transbronchial cryoablation. Additionally, no adverse events requiring intervention occurred. Mild thrombocytopenia occurred in one patient 3 days after cryoablation and recovered spontaneously within 1 month. One patient experienced a self-limiting, low-grade fever 3 days after cryoablation, which was considered a postoperative stress response. A mild pneumothorax was observed in a patient’s intraprocedural CBCT. Without any treatment, follow-up CT 1 month later revealed that the pneumothorax had resolved (Figure 1E,1F). Following the ablation, one patient developed atelectasis in the contralateral lung, which may result from aspiration. The patient was discharged as scheduled, given the asymptomatic status. Follow-up CT 1 month post-procedure demonstrated complete resolution (Figure S1). Information associated with adverse events is summarized in Table 2.

Discussion

We carried out the first transbronchial cryoablation for peripheral pulmonary lesions (22). Hence, the current retrospective study provided the longest available follow-up data. This allowed us to demonstrat the mid-term efficacy and safety of transbronchial cryoablation in treating stage IA peripheral lung cancer for the first time.

Radiotherapy, particularly stereotactic body radiation therapy (SBRT), has become the standard treatment for medically inoperable early-stage non-small cell lung cancer, with reported 3-year local control rate ranging from 77.9% to 88% in patients with stage I lung cancer (27-29). Similarly, percutaneous cryoablation has emerged as a minimally invasive alternative. A multi-center retrospective study indicated that on stage I lung cancer percutaneous cryoablation achieved 1- and 2-year local control rates of 79% and 73%, respectively (30). Meanwhile, a recent retrospective study reported a 3-year LPFS rate of 89.4% for percutaneous cryoablation in stage IA lung cancer (31). Our study demonstrated that transbronchial cryoablation may be a novel approach for this patient population. Compared to previous work, the present study exhibited comparable 3-year LPFS rate of 89.2%. In our study, two patients with solid nodules experienced local tumor progression due to insufficient ablation margin. In one case, patient received cryoablation with a freeze-thaw time of 7 and 3 minutes for each cycle of ablation due to safety concern during the initial phase of this study. In another case, patient was diagnosed as adenocarcinoma with papillary and micropapillary patterns indicating a more aggressive biological behavior. Taken together, this inspired us to think that inadequate freeze time may result in incomplete ablation, and for more malignant tumors, longer freeze time and additional cycles may be needed. Additionally, combined cryoablation with RAB and real-time imaging integration with CBCT, which enables establishment of direct tunnels and precise multi-point ablation, may further enhance targeting accuracy and ensure more reliable coverage of the ablation zone (23).

No procedure-related death has been observed in this study, and only four mild treatment-related complications occurred. Importantly, when compared to SBRT, transbronchial cryoablation exhibited complete avoidance of radiation toxicities (10). Hence, compared with SBRT, transbronchial cryoablation can be repeatable without cumulative toxicity concerns, can be conducted in lesions adjacent to radiosensitive structures, and may represent a particularly appropriate alternative for patients who concern about radiation-induced pneumonitis, such as those with chronic obstructive pulmonary disease (COPD) or other conditions associated with impaired pulmonary function. Moreover, transbronchial cryoablation exhibited a significantly lower incidence of pneumothorax requiring clinical intervention (0.0%) compared to percutaneous cryoablation (15.0–26.0%) (31-33). Furthermore, compared with SBRT and percutaneous cryoablation, the transbronchial approach offers a distinct advantage in that biopsy can be safely performed during the same procedure, enabling simultaneous pathological confirmation and cryoablation in a single session (23). Additionally, unlike heat-based ablation, cryoablation can be safely applied in high-oxygen environments and for tumors near critical structures, such as great vessels, pericardium, pleura, or fissures (22,34,35). In our study, 11 lesions (45.8%) were adjacent to the pleura and interlobar fissure, cryoablation was successfully performed without any severe complications. What is more, when compared to previously published data on transbronchial microwave (13.3–18.2%) (18,36) or radiofrequency ablation (6.3–9.8%) (20,21), our study revealed a lower incidence of serious adverse events (0.0%). Taken together, this data demonstrated that transbronchial cryoablation achieved enhanced overall safety, not only by the intrinsic benefits of cryoablation but also by reducing the pleural injury risk due to the percutaneous puncture.

However, there are still several limitations in this study. Firstly, this was a single-center, retrospective analysis with a limited sample size, which may restrict the generalizability of the results. Secondly, the study did not enroll randomized control group to compare transbronchial cryoablation with percutaneous cryoablation or other transbronchial thermal ablation techniques directly. Finally, overall survival was not evaluated due to a follow-up duration of less than 5 years. Larger, prospective, randomized controlled trials are necessary to confirm these findings.

Conclusions

In conclusion, our mid-term retrospective analysis indicated that transbronchial cryoablation may be an effective and safe treatment option for patients with stage IA peripheral lung cancer. Prospective, multi-center, large-scale studies, particularly randomized controlled trials that compare transbronchial cryoablation with percutaneous cryoablation, are needed to evaluate its clinical efficacy.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the STROBE reporting checklist. Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-1-0043/rc

Data Sharing Statement: Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-1-0043/dss

Peer Review File: Available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-1-0043/prf

Funding: This study was supported by the National Multi-disciplinary Treatment Project for Major Diseases (No. 2020NMDTP), and Shanghai Hospital Development Center Foundation (No. SHDC12022109).

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://tlcr.amegroups.com/article/view/10.21037/tlcr-2026-1-0043/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. This study was conducted in accordance with the Declaration of Helsinki and its subsequent amendments. The study was approved by the Ethics Committee of Shanghai Chest Hospital (No. IS25234). Due to the retrospective nature of this study and the use of anonymized clinical data, the requirement for informed consent was waived by the Ethics Committee.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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