Clinical Trials Directory

Trials / Completed

CompletedNCT01841060

Assessment of the Effectiveness of Local Ablathermy Radio Frequency Bronchial Tumors Primitive

Assessment of the Effectiveness of Local Ablathermy Radio Frequency (RF) Bronchial Tumors Primitive Stage IA Non-surgical Patients. Phase II Multicenter National

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Institut Bergonié · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Lung tumors of non-small cell stage 1A are usually treated surgically but many patients are not operable because of their condition or respiratory problems associated with it. The treatment is then suggested that local radiotherapy is conventionally carried out in split mode for 6 weeks at a dose of 60-65 Gy irradiation mode This exposes the patient to complications, including post-radiation pneumonitis.

Detailed description

Lung tumors of non-small cell stage 1A are usually treated surgically but many patients are not operable because of their condition or respiratory problems associated with it. The treatment is then suggested that local radiotherapy is conventionally carried out in split mode for 6 weeks at a dose of 60-65 Gy irradiation mode This exposes the patient to complications, including post-radiation pneumonitis. This can be problematic in patients with respiratory failure for which surgical treatment has been challenged. Radiofrequency pulmonary developed as a therapeutic alternative, it has the advantage of being performed in a session with less toxicity in the lung parenchyma

Conditions

Interventions

TypeNameDescription
PROCEDUREPercutaneous radiofrequency ablation (RFA)Computed tomography (CT) was used to treat tumors under general anesthesia. Thoracic epidural anesthesia was administered in case of contraindication to general anesthesia mostly due to poor respiratory function. All patients were treated with the same multitine electrodes (LeVeen; Boston Scientific, Nattick. MA) measuring 3, 3.5, or 4 cm in diameter and at least 10 mm larger than the diameter of the target tumor. Multiple overlapping ablations were performed, when needed, in different parts of the tumor in order to cover the entire volume.

Timeline

Start date
2008-11-01
Primary completion
2011-07-01
Completion
2011-12-01
First posted
2013-04-26
Last updated
2021-01-19
Results posted
2021-01-19

Locations

9 sites across 1 country: France

Source: ClinicalTrials.gov record NCT01841060. Inclusion in this directory is not an endorsement.