The National Institute for Clinical Excellence is examining endoscopic transsphenoidal pituitary adenoma resection and will publish guidance on its safety and efficacy to the NHS in England and Wales. 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 endoscopic transsphenoidal pituitary adenoma resection. This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendations made by the Advisory Committee.

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.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare the Final Interventional Procedures Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 2 September 2003

Target date for publication of guidance: 26 November 2003

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence on the safety and efficacy of endoscopic transsphenoidal pituitary adenoma resection appears adequate to support the use of the procedure, provided that normal arrangements are in place for consent, audit and clinical governance.

The procedure should be carried out by clinicians with experience in endoscopic nasal surgery, and within a multidisciplinary centre.

Endoscopic transsphenoidal pituitary adenoma resection is used to treat pituitary adenomas. Pituitary adenomas are benign slow-growing tumours that arise within the pituitary gland. Most pituitary adenomas are small (microadenomas), though a few patients have larger tumours (macroadenomas).

The symptoms of pituitary adenoma depend on the location, severity and size of tumour.

The treatment options for pituitary adenoma include surgery, pharmacological therapy, and radiotherapy. Surgery remains the first-line treatment for symptomatic pituitary adenoma. Surgery may also be used if pharmacological therapy or radiotherapy fails.

Under general anaesthetic, an endoscope is inserted through the nostril and is directed towards the base of the tumour at the skull base. Surgical instruments are then inserted next to the endoscope through the same nostril. The tumour is removed.

The evidence indicated that endoscopic transsphenoidal pituitary adenoma resection resulted in surgical outcomes comparable with those achieved using conventional surgery, which is carried out through the skull.

The operating time for endoscopic transsphenoidal resection was shorter compared with conventional surgery. The length of hospital stay was also shorter with the endonasal procedure: 2-5 days compared with 4-10 days for conventional surgery.

The majority of the Specialist Advisors considered the procedure to be a minor variation of an existing procedure, and the likely efficacy of resection to be unchanged. The Advisors commented that incomplete tumour removal was a possibility with this procedure.

The evidence indicated that major morbidity (cerebrospinal fluid leak, meningitis, stroke, intracranial haemorrhage, or visual loss) occurred in only a small number of cases. Less serious complications (sinusitis and nasal septal perforations) occurred in less than 7% of patients. The complication rate associated with endoscopic transsphenoidal pituitary adenoma resection was lower than the rates associated with conventional surgery.

The most serious reported complication of the procedure was meningitis. This occurred in two patients in the two largest case series, which included 310 patients. For more details refer to the Overview (see Appendix A).

The Specialist Advisors did not report any particular safety concerns, though bleeding, optic nerve damage, cerebrospinal fluid leakage, and carotid artery injury were noted as potential complications of endoscopic transsphenoidal pituitary adenoma resection.

The Advisory Committee noted that there was a lack of long-term follow-up data on this procedure.

The following source of evidence was considered by the Interventional Procedures Advisory Committee.

• Interventional Procedure Overview of Endoscopic Transsphenoidal Pituitary Adenoma Resection, August 2003