Cryotherapy, NSCLC, RFA
Conditions
Keywords
Tumor Staging and Resection
Brief summary
In order to secure the diagnosis of lung cancer, the investigator will perform a bronchoscopy in order to take tissue samples. These samples will be analyzed in the pathology. This is the routine standard. The aim of the study is to treat the lesion with a device that works both with cold and radiofrequency. The device is already in use for the treatment of lesions. The device allows direct treatment of the lesion during the routine bronchoscopy. As planned, the lesion will then be surgically removed. After the surgery the lesion will be analyzed in the pathology to show the effect of the use of the device. This additional treatment is safe and will support the treatment of the lesion. There are no additional steps or assessments for the participants to undergo.
Interventions
DEVICECryotherapy
Transbronchiual Cryo-assisted RFA During Routine Standard Bronchoscopic Tumor Staging and Resection
Sponsors
Elisabethinen Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Solitary nodule ≤ 2.5 cm * Candidate for diagnostic bronchoscopy \& LN staging * Eligible for surgical resection * Histologically proven lung cancer * ≥20 mm margin to pleura/vessels/bronchi * Signed informed consent, age ≥18 y.
Exclusion criteria
* Pregnancy/nursing * central tumours abutting vital structures * thoracic electronic implants * uncorrectable coagulopathy or platelets ≤50 × 10⁹/L * severe uncontrolled comorbidities or infection; prior SBRT to zone * recent investigational therapy (\<30 d) * atelectasis/obstructive pneumonitis/effusion/fibrosis * investigator-determined risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful device use, defined as the completion of ablation with the HybridTherm® system with investigator confirmation that the ablation zone achieved sufficient coverage based on intra-procedural imaging. | during procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety outcomes, with a specific focus on bleeding events, graded according to the Nashville Bleeding Scale, and the occurrence of other adverse events as documented in the medical record. | up to 6 - 7 weeks post procedure | Nashville Bleeding Scale Grade Findings at Bronchoscopy Rationale 1. Suctioning of blood required for less than 1 minute Minimal bleeding of no clinical consequence to the patient or the provider 2. Suctioning more than 1 minute, or repeat wedging of the bronchoscope for persistent bleeding, or instillation of cold saline, diluted vasoactive agents, or thrombin Requires tools to control or prevent further bleeding 3. Selective intubation with endotracheal tube (ETT) or balloon/bronchial blocker for \< 20 minutes, or premature interruption of the procedure Short-term but clinically meaningful change requiring more invasive intervention and procedure interruption 4. Persistent selective intubation \> 20 minutes, or ICU admission, or PRBC transfusion, or need for bronchial artery embolization or resuscitation Indicates serious deterioration, requiring escalation of care and advanced ventilatory and hemodynamic support |
| Macroscopic and microscopic evidence of ablation in the resected specimen, assessed using standard histopathological methods (H&E staining). | within 24 hours after procedure | — |
| Visual estimation of histopathologic ablation completeness, defined as the estimated percentage of tumor necrosis within the ablation zone, as determined by routine pathology reporting. | within 24 hours after procedure | — |
| Evaluation of macroscopic and microscopic necrosis within the ablation zone (histopathologic complete response hpCR), defined as the absence of viable tumor cells within the ablated area, if reported as part of routine histological assessment. | within24 hours after procedure | — |
| Descriptive intra-procedural metrics, recorded during the bronchoscopy procedure: Total ablation time; Number of cryoRFA activations; Electrical parameters of energy delivered during the procedure; Number of probe repositioning within the lesion | day 0 | total ablation time will be recorded in minutes; number of cryoRFA activations will be recorded in energy applications; |
| Estimated ablation zone size (mm), derived from intraoperative CBCT, routinely obtained during the procedure. | day 0 | — |
Countries
Austria
Contacts
CONTACTAdrienne Seil
CONTACTJulia Dort
PRINCIPAL_INVESTIGATORChristopher Lambers
Elisabethinen Hospital
Outcome results
None listed