Robotic-assisted bronchoscopy (RAB) should be available as a diagnostic biopsy option for patients with pulmonary lesions identified on computed tomography (CT) imaging that are suspected of being lung cancer. RAB should be the preferred biopsy technique for patients with small (<20mm) peripheral lesions that are not suitable for sampling using conventional techniques.
Access to RAB should be equitable and consistent across Scotland, ensuring all eligible patients have access regardless of geographic location. Successful introduction of RAB will require comprehensive training for clinicians in the safe and effective use of this technology and adequate infrastructure for the decontamination, sterilisation and ongoing quality assurance of reusable RAB bronchoscopes.
The use of RAB should be accompanied by systematic data collection and analysis to inform future decision making regarding its role within Scottish lung cancer diagnostic pathways.
NHSScotland is required to consider the Scottish Health Technologies Group (SHTG) recommendations.
1. The Council agreed that RAB offers a high diagnostic yield and low complication rates, making it an effective and safe diagnostic option for patients. The Council felt that RAB was likely to be especially beneficial for patients with hard-to-reach lesions that are not accessible using conventional biopsy techniques. Introducing RAB would offer extra diagnostic capacity in advance of the rollout of a national lung cancer screening programme to help improve the early diagnosis of lung cancer in Scotland.
2. A clinical expert advised the Council that published studies comparing RAB with conventional biopsy techniques were likely to include two different patient populations because people with small, peripheral nodules that did not have a bronchus sign would not be considered for biopsy using conventional techniques but would be suitable for biopsy using RAB.
3. The Council acknowledged that interpreting the evidence on RAB was difficult because of variations in the definitions of diagnostic yield used across the published studies. A clinical expert advised that efforts continue to be made at an international level to agree a strict definition of diagnostic yield which would help improve consistency in definitions and reporting across future studies.
4. Council members expressed strong objections to having the economic analysis data redacted because of the need for pricing confidentiality. Members felt that this made it impossible to judge the appropriateness of the analysis and its conclusions. The Council agreed to limit the conclusion of the economic analysis to exploratory or indicative only.
5. A clinical expert and patient group representative explained to the Council that people with small (<20 mm) lung lesions were often put on a ‘watch and wait’ list. Patients on these lists received a CT scan after 3 months, 1 year, 2 years and would be discharged from the list after 3 years if their pulmonary nodule remained stable. If the nodule was found to be growing during this time, the patient would begin treatment with surgery or radiotherapy without a confirmed diagnosis. This causes some patients and their families a great deal of anxiety, distress and confusion.
6. The Council recognised the importance of RAB to patients who may not be able to have a timely biopsy using conventional techniques. This issue was highlighted by a presentation to Council by the Roy Castle Lung Cancer Foundation.
7. The Council observed that Scotland does not currently have a lung cancer screening programme or RAB, both of which are available in England. They acknowledged that this leads to inequities in access to healthcare for people with a high risk of lung cancer living in different parts of the United Kingdom (UK).
8. The Council noted that a national lung cancer screening programme for Scotland is planned to begin in late 2027. The introduction of this programme is expected to generate an increase in the number of patients requiring diagnostic biopsies for small nodules suspected of being early-stage lung cancer. The Council recognised that, without RAB in place ahead of the programme’s launch, services may be unable to manage the resulting demand, leading to significant delays for patients awaiting biopsy.
9. The Council acknowledged that the Ion™ RAB device is the only platform currently available for purchase in Scotland. The Council also noted that most of the published evidence on RAB related to the Ion™ platform and that the findings of studies on the Ion™ platform may not generalise to the Monarch™ or Galaxy™ platforms.
10. The Council discussed how many RAB devices would be needed across NHSScotland. It was agreed that this was not the responsibility of the Council, but that RAB devices would not be needed in every hospital. The Council flagged that a minimum caseload is likely to be required to maintain an acceptable level of expertise in using RAB.
11. The Council highlighted the value of gathering and analysing data on the use of RAB in Scotland in a way that could be shared and compared with registry data from England or Europe.
1. Systematic reviews of RAB combined results from studies assessing different RAB platforms and did not adequately report patient characteristics or the appraisal of primary study quality. Many of the primary studies recruited small numbers of highly selected patients and few studies directly compared RAB with other diagnostic modalities.
2. A systematic review with meta-analysis (27 studies, n=2,315) reported a diagnostic yield (calculated based on intermediate criteria) of 86.6% (95% confidence interval [CI] 83.7% to 89.2%) for RAB in patients with peripheral lung nodules and a suspicion of cancer.2 In the meta-analysis, pneumothorax occurred in 2.0% of patients having RAB (95% CI 1.3% to 2.7%).
3. A network meta-analysis (NMA; 37 studies, n=4,285) found no statistically significant differences in diagnostic yield (intermediate criteria) between RAB and CT-guided transthoracic bronchoscopy (CTTB), endobronchial ultrasound (EBUS), virtual bronchoscopic navigation (VBN) or electromagnetic navigation bronchoscopy (ENB) in patients with peripheral pulmonary lesions.3 Only three studies (n=242) contributed data on patients undergoing RAB in these comparisons.
4. Five primary studies compared RAB using the Ion™ platform with other diagnostic modalities. The patients in each group across these five studies may be highly selective because individuals eligible for RAB may be unsuitable for the comparator diagnostic modalities because of the size or anatomical location of their pulmonary nodules.
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- A cluster randomised trial (n=411) comparing RAB with ENB in patients with peripheral pulmonary lesions found no statistically significant difference between the two modalities when diagnostic yield was calculated using strict criteria (odds ratio [OR] 1.23, 95% CI 0.73 to 2.07). Pneumothorax was reported in 1.97% of patients in the RAB group and 2.88% of patients in the ENB group (OR 0.39, 95% CI 0.12 to 1.25).
- A retrospective cohort study (n=92) comparing RAB with ENB in patients with pulmonary nodules reported a statistically significantly higher diagnostic yield (strict criteria) from RAB (89% versus 66%, p<0.001). Pneumothorax was reported in 1.8% of patients in the RAB group and 2.1% of patients in the ENB group.
- A second retrospective cohort study (n=116) comparing RAB with ENB in patients with pulmonary nodules also reported statistically significantly higher diagnostic yield (intermediate criteria) from RAB (86.1% versus 49.5%, p<0.0001). No complications were reported in either group in this study.
- A retrospective cohort study (n=59) comparing RAB with VBN in patients with peripheral pulmonary nodules reported that diagnostic yield (intermediate criteria) was 90% for RAB compared with 69% for VBN (p=0.045). Pneumothorax was reported in 6.9% of patients in the VBN group and no patients in the RAB group (p=0.237).
- A retrospective cohort study (n=296) comparing RAB with CTTB in patients with pulmonary nodules found no statistically significant difference in diagnostic yield between the two modalities using strict criteria (86.48% versus 89.18%, p=0.594). Pneumothorax was reported in 3.38% of patients in the RAB group compared with 44.45% in the CTTB group (p<0.001).
5. A retrospective cohort study (n=162) compared the diagnostic yield (strict criteria) between the Ion™ and Monarch™ RAB platforms in patients with pulmonary lesions.9 Diagnostic yield was statistically significantly higher with the Ion™ platform compared with the Monarch™ platform (84.2% versus 71.0%, p=0.003). There were no statistically significant differences in complication rates between the two platforms.
6. A patient organisation submission from the Roy Castle Lung Cancer Foundation reported that:
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- lung cancer can have life-limiting symptoms with serious effects on patients’ physical and emotional well-being, quality of life and ability to perform daily tasks
- there is an unmet need among patients with small peripheral pulmonary lesions that are not suitable for biopsy using conventional techniques
- patients with lung lesions who are placed on a ‘watch and wait’ list, which may be for as long as 3 years, experience anxiety and may undergo unnecessary invasive treatments for lung cancer
- patients having RAB need a general anaesthetic rather than the sedation used for a standard bronchoscopy, but some patients prefer general anaesthesia
- RAB offers patients hope of a definitive diagnosis and improved outcomes.
7. Lung cancer incidence and mortality are approximately three times higher among people living in the most deprived areas of Scotland compared with people living in the least deprived areas. Ethnicity, sex, age and smoking status were each statistically significantly associated with people having late-stage (III or IV) lung cancer at diagnosis.
8. Organisational issues relating to the introduction of RAB include a recognised learning curve for clinicians, a need for training on using the RAB platforms and the need for infrastructure to manage cleaning and monitoring of reusable RAB bronchoscopes.
9. We performed an exploratory economic analysis comparing RAB with usual care, which suggested that RAB (Ion™ platform) is expected to be cost effective. The analysis assumes that a proportion of patients who would otherwise be on a ‘watch and wait’ list would be able to get an earlier biopsy-confirmed diagnosis with RAB, which would lead to earlier treatment and improved 5-year survival rates. The results of our analysis were consistent across sensitivity analyses including the time horizon and the assumed proportion of patients diagnosed with early-stage lung cancer in the RAB arm of the model. A lack of comparative clinical data means our analysis should be viewed as indicative.
What were we asked to look at?
We were asked to review the evidence on the clinical effectiveness, cost effectiveness and safety of RAB for diagnosing lung lesions suspected of being cancer.
Why is this important?
A lung nodule biopsy is needed to accurately diagnose patients with suspected lung cancer. Conventional techniques are unable to reliably biopsy peripheral pulmonary lesions or nodules <20 mm in diameter. Patients with these peripheral or small nodules who cannot get a biopsy-confirmed diagnosis may experience anxiety, disease progression or unnecessary aggressive treatments. The planned introduction of lung cancer screening in Scotland from 2027 is expected to increase the number of patients needing diagnostic biopsies of small pulmonary nodules, not all of which will be suitable for conventional biopsy procedures. RAB may be an option for obtaining biopsy-confirmed diagnoses for these patients. RAB is not currently available in NHSScotland.
