Interventional Procedures Consultation Document - Cryosurgery for malignant endobronchial obstruction
NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE
Interventional Procedure Consultation Document
Cryosurgery for malignant endobronchial obstruction
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The National Institute for Health and Clinical Excellence is examining cryosurgery for malignant endobronchial obstruction and will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about cryosurgery for malignant endobronchial obstruction. This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:
Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation. The process that the Institute will follow after the consultation period ends is as follows.
For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual). Closing date for comments: 21 June 2005 Target date for publication of guidance: September 2005 |
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Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation. |
| 1 | Provisional recommendations |
| 1.1 |
Current evidence on the safety and efficacy of cryosurgery for malignant endobronchial obstruction appears adequate to support the use of this procedure provided that the normal arrangements are in place for consent, audit and clinical governance. |
| 1.2 | Clinicians should ensure that patients fully understand that this is one of a variety of treatment options available. |
| 2 | The procedure |
| 2.1 | Indications |
| 2.1.1 |
Lung cancer is often at an advanced stage when it is diagnosed, with low survival rates. Patients can develop endobronchial lesions that obstruct the major airways, causing symptoms such as dyspnoea, cough, haemoptysis and postobstructive pneumonia. Bronchial obstruction may lead to gradual asphyxiation. |
| 2.1.2 | The aim of treatment in patients with malignant endobronchial obstruction is mainly palliative. Current treatment options include a variety of endobronchial therapies such as bronchoscopic resection, brachytherapy, laser ablation, photodynamic therapy and stenting. External beam radiotherapy and chemotherapy may also be used for palliative treatment. |
| 2.2 | Outline of the procedure |
| 2.2.1 | General anaesthesia is usually used. A cryoprobe is inserted through a bronchoscope to reach the tumour; the selection of probe diameter depends on the size and position of the tumour. After a period of freezing, the tumour is allowed to thaw until the probe separates from the tissue. The freeze/thaw cycle may be repeated two to three times in the same place. The probe is then moved to an adjacent area and the process is repeated until the whole tumour has been treated. Any resulting necrotic tumour material is then removed with forceps or using the cryoprobe. Further necrotic material may be expectorated during the following 24-48 hours. The procedure can be repeated if necessary. |
| 2.2.2 | Cryotherapy does not provide immediate relief of bronchial obstruction and is therefore not suitable for the emergency treatment of acute respiratory distress. |
| 2.3 | Efficacy |
| 2.3.1 |
The main aim of the procedure in the studies was palliation of symptoms such as cough, dyspnoea and haemoptysis. In one case series of 521 patients, 86% (448/521) had improvement in one or more symptoms and quality of life scores were significantly improved. Dyspnoea improved in 59% (300/507) of patients. In two further studies, dyspnoea improved in 71% (12/17) and 81% (87/107) of patients. For more details, refer to the sources of evidence (see Appendix). |
| 2.3.2 |
The Specialist Advisors did not express any major concerns about the efficacy of this procedure. |
| 2.4 | Safety |
| 2.4.1 |
A large case series study reported in-hospital mortality of 1% (7/521), which was due to respiratory failure. This study also reported that 3% (16/521) of patients developed respiratory distress after the procedure. |
| 2.4.2 | A case series study of 27 patients reported one death due to myocardial ischaemia. Another study of 22 patients reported one cardiopulmonary arrest during the procedure. Two studies reported changes to the heart rhythm in 2% (12/521) and 11% (3/27) of patients. For more details, refer to the sources of evidence (see Appendix). |
| 2.4.3 | The Specialist Advisors listed haemorrhage, fistula formation, cardiac arrhythmias, respiratory distress and infection as potential adverse effects. |
| 3 | Further information |
| 3.1 | The Institute has issued guidance on the diagnosis and treatment of lung cancer (www.nice.org.uk/CG024). The Institute has also issued Interventional Procedures guidance on the use of photodynamic therapy for advanced bronchial cancer (www.nice.org.uk/IPG087guidance) and is developing guidance on photodynamic therapy for localised inoperable endobronchial cancer (www.nice.org.uk/ip270). |
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
June 2005
| Appendix: | Sources of evidence |
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The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations. Interventional procedure overview of cryosurgery for malignant endobronchial obstruction, February 2005 Available from: www.nice.org.uk/ip285overview | |
This page was last updated: 07 February 2011