- The study addressed the lack of formal guidance for 1.1 mm transbronchial cryobiopsy in non-interstitial lung disease indications.
- An international panel of 32 physicians used a modified Delphi methodology over four rounds to establish consensus statements.
- The expert panel reached consensus on 31 statements regarding indications, techniques, and safety, but not on 17 statements.
- The authors concluded this Delphi statement provides the first expert guidance for non-interstitial lung disease transbronchial cryobiopsy.
- This guidance helps standardize contemporary best practices and identifies areas requiring further research for clinicians.
Standardizing Transbronchial Cryobiopsy Beyond Interstitial Lung Disease
The accurate diagnosis of peripheral pulmonary lesions and mediastinal pathologies often requires tissue acquisition, yet obtaining sufficient material for comprehensive analysis can be challenging [1, 2]. While endobronchial ultrasound-guided transbronchial needle aspiration is a first-line method for mediastinal staging, transbronchial cryobiopsy has gained traction for its ability to yield larger, less fragmented tissue samples compared to conventional forceps biopsies, enhancing diagnostic confidence in conditions like interstitial lung disease [3, 4, 5]. Recently, the technique's application has expanded into non-interstitial lung disease contexts, including peripheral and endobronchial ultrasound-guided sampling, largely facilitated by smaller, single-use cryoprobes [6, 7]. This rapid adoption has created a significant gap where practice variability has outpaced the generation of evidence and formal guidance, underscoring an urgent need for expert consensus to ensure safe and effective use.
Addressing Practice Variability in Advanced Lung Biopsy
The utility of transbronchial cryobiopsy has broadened considerably from its established role in interstitial lung disease, a development driven by the availability of new single-use instruments. The 1.1 mm cryoprobe, in particular, has been instrumental in this expansion, allowing clinicians to apply the technique to a wider array of diagnostic challenges, such as sampling peripheral pulmonary lesions and performing cryobiopsy under convex-probe endobronchial ultrasound guidance. However, this accelerating use of transbronchial cryobiopsy across non-interstitial lung disease diagnostic contexts has created a clinical dilemma. Without established protocols, practice variability has outpaced both evidence generation and formal guidance. This inconsistency in procedural technique, patient selection, and safety measures necessitates a unified set of recommendations to standardize care and optimize diagnostic outcomes for patients.
Methodology: Building Consensus Among Experts
To address this need for standardization, an international panel of 32 bronchoscopy experts, convened through the Interventional Pulmonology Outcomes Group, sought to formulate clinical consensus statements. The study's objective was to provide guidance on the indications, tools, techniques, specimen handling, safety, and procedural expertise required for using the 1.1 mm cryoprobe in non-interstitial lung disease transbronchial cryobiopsy. The scope specifically included both peripheral pulmonary lesion sampling and procedures guided by convex-probe endobronchial ultrasound. The researchers employed a modified Delphi methodology, a structured process designed to aggregate expert opinions and move toward agreement. Following a comprehensive evidence review, the process began with a round of open-ended questions to identify key issues. This was followed by 3 subsequent rounds where panelists rated their agreement with specific statements on a 5-point Likert scale. A statement was considered to have reached consensus if it achieved ≥ 80% agreement. This entire four-round process was conducted between May and November 2025.
Key Domains and Consensus Outcomes
The expert panel's work was organized across four distinct domains to ensure comprehensive guidance for the entire procedural workflow. These domains included: (1) peripheral transbronchial cryobiopsy, for sampling lesions in the outer lung parenchyma; (2) convex-probe endobronchial ultrasound-guided cryobiopsy, for targeting mediastinal or hilar lymph nodes and masses; (3) airway, anesthesia, and complication management, covering critical patient safety protocols; and (4) specimen handling and processing, to ensure the diagnostic quality of the tissue obtained. This structured approach provided a systematic review of the procedure from patient selection through to pathological analysis. From this rigorous process, the panel successfully reached consensus on 31 statements, establishing a clear foundation of expert-backed best practices. However, consensus was not achieved on 17 statements. These areas of disagreement are also clinically significant, as they pinpoint topics where evidence is lacking or expert opinion diverges, highlighting priorities for future investigation.
Implications for Clinical Practice and Future Research
This work carries immediate weight for practicing pulmonologists, as this Delphi statement represents the first expert guidance for non-interstitial lung disease applications of both endobronchial ultrasound-guided and peripheral transbronchial cryobiopsy. For clinicians, the 31 consensus statements provide a much-needed framework that can directly inform procedural technique, safety protocols, and patient management in areas where practice has been highly variable. By following these recommendations, practitioners can align their methods with contemporary best practices agreed upon by international experts, which may help standardize and improve diagnostic yields. The statements effectively bridge critical gaps in standardization, offering a more unified approach to these advanced bronchoscopic procedures. Furthermore, the 17 statements that did not reach consensus serve a vital purpose by outlining domains where further research is needed. They provide a clear roadmap for investigators, directing future studies toward the specific clinical questions that must be answered to resolve current uncertainties and further refine patient care.
References
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