Advice
Clinical and technical evidence
Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.
Published evidence
Four studies are summarised in this briefing, selected on the basis of the most relevant technology and outcomes, including 3 prospective interventional studies and 1 retrospective study. There were 59 people with lung nodules in total in the selected studies.
The clinical evidence, and its strengths and limitations, is summarised in the overall assessment of the evidence.
Overall assessment of the evidence
There is limited high-quality evidence for the Archimedes System. None of the included studies were done in the UK.
Primary outcomes include diagnostic yield and adverse events, such as incidence of procedure-related pneumothorax. The common limitations across the studies are small sample sizes and no comparative data.
There is no evidence from randomised controlled trials and the place for this technology in the NHS, alongside other guided bronchoscopy techniques, is not yet established. More evidence on benefits and costs is needed, including UK-based studies. A multicentre prospective randomised trial could address the overall risks and benefits of using the system. Archimedes may be suitable for people for whom CT guided biopsy is thought to be high risk or if a leading airway path to the lesions cannot be identified.
Herth et al. (2018) (abstract)
Study size, design and location
A prospective single-arm interventional study. The study location was not reported in the abstract. The study included 16 people with no leading airway path to the solitary pulmonary nodule.
Intervention and comparator
Archimedes was used to reconstruct CT data of eligible participants. There was no comparator in the study.
Ramzy et al. (2018) (abstract)
Study size, design and location
A retrospective interventional study in the US. The study evaluated 25 people (27 lesions) who had BTPNA with intra-procedure fused fluoroscopy for the biopsy of a solitary pulmonary nodule.
Intervention and comparator
Archimedes was used to reconstruct CT data of eligible participants. There was no comparator in the study.
Key outcomes
Twenty-four people completed the procedure. The diagnostic yield of the procedure was 85%. Of lesions evaluated, 8 lesions (31%) were detected as malignant and 13 lesions (54%) were benign. Four lesions (15%) were indeterminate on final pathological review. Two people had minimal biopsy airway bleeding after the procedure; no one developed pneumothorax.
Harzheim et al. (2016)
Study size, design and location
A prospective, single-arm interventional study in Germany. The study recruited 6 people with pulmonary nodules (lesions of a diameter up to 30 mm).
Intervention and comparator
Archimedes was used to reconstruct CT data of eligible participants. There was no comparator in the study.
Key outcomes
Six people were enrolled in the study. A positive biopsy was obtained in 5 people (83%) in which BTPNA could be successfully completed. Adequate histological sampling for a histological diagnosis was obtained in 5 people. The biopsies obtained by BTPNA correlated with the final pathology in 4 surgically resected nodules.
There were no significant adverse events during the procedure. Two pneumothoraces were diagnosed by chest X‑ray 2 hours after the procedure, with 1 pneumothorax requiring drainage.
Herth et al. (2015)
Study size, design and location
A prospective single-arm interventional study in Germany. The study recruited 12 people with pulmonary nodules (lesions of up to 40 mm diameter from suspected lung cancer or metastatic disease) when surgical resection was suitable.
Intervention and comparator
The Archimedes virtual bronchoscopy navigation system was used to reconstruct CT data of eligible participants. There was no comparator in the study.
Key outcomes
The BTPNA procedure was successfully completed in 10 people (83%), and adequate sampling for a histological diagnosis was obtained. Inspection at surgery and in the postresection specimens showed that the tunnel path was created in the correct position and that orientation led directly to the target nodule. The histological findings from the biopsies obtained by BTPNA correlated with the final pathology in all of the surgically resected nodules. In the 2 people in whom the BTPNA procedure could not be completed, the nodules were located in the apical section of the left upper lobe.
There were no significant adverse events during the procedure. The only adverse event was a transient rise in troponin levels in 1 person after the BTPNA procedure and surgical resection. Outpatient follow up at 90 days and 180 days after the procedure did not reveal any adverse events attributable to the procedure.
Sustainability
The company claims that the single-use components of the technology can be disposed of by the hospital's recycling or disposing scheme. When the workstation and software come to the end of their lives, they will be recycled by the company in line with best practice at the time. There is no published evidence to support these claims.
Recent and ongoing studies
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Evaluation of the Archimedes System for Transparenchymal Nodule Access 2 (EAST2). ClinicalTrials.gov Identifier: NCT02867371. Status: recruitment completed. No interim results published. Indication: lung cancer. Devices: Archimedes. Last update on 1 November 2019. US.