Interventional procedure consultation document

Laparoscopic cryotherapy for renal cancer

Treating kidney tumours by keyhole surgery and freezing (cryotherapy)

Renal cancer occurs in the lining of the very small tubes in the kidney. Cryotherapy involves applying freezing temperatures to the tumour by inserting a surgical instrument (cryoprobe) through several small incisions in the abdomen (‘keyhole’ surgery), with the aid of an internal telescope and camera system (laparoscope).  The aim is to destroy cancer cells.

The National Institute for Health and Clinical Excellence (NICE) is examining laparoscopic cryotherapy for renal cancer and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about laparoscopic cryotherapy for renal cancer.

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:

• comments on the provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE 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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination and promote equality and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 21 April 2011

Target date for publication of guidance: July 2011

1   Provisional recommendations

1.1  Current evidence on the efficacy and safety of laparoscopic cryotherapy for renal cancer is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit.

1.2  This procedure should only be offered after assessment by a specialist urological cancer multidisciplinary team.

1.3  NICE encourages collection and publication of data on the outcomes of this procedure in the long-term. Further research should compare the long-term outcomes of cryotherapy with those of other treatments for renal cancer.

2   The procedure

2.1  Indications and current treatments

2.1.1  The most common type of renal cancer in adults is renal cell carcinoma. Symptoms and signs may include pain and haematuria. Some tumours are identified asymptomatically, through imaging. Establishing diagnosis and assessing the prognosis of some renal tumours may be difficult.

2.1.2  Treatment options include laparoscopic (or open) partial or total nephrectomy, and ablation techniques including radiofrequency ablation (RFA).

2.2   Outline of the procedure

2.2.1  Laparoscopic cryotherapy for renal cancer is carried out with the patient under general anaesthesia. A transperitoneal or retroperitoneal approach can be used. Under suitable imaging guidance, a probe is inserted into the tumour to deliver a coolant at subfreezing temperatures, creating an ice ball around the probe’s tip, which destroys the surrounding tissue. Each freeze cycle is followed by a heat (thaw) cycle, allowing removal of the probe. Two freeze–thaw cycles are usually performed to ablate the tumour (additional cycles may also be performed if necessary), with the aim of extending the ice ball approximately 1 cm beyond tumour margins. More than 1 probe can be used.

2.2.2  The maximum renal tumour size for which cryotherapy is recommended is approximately 4 cm (small, stage I tumours).

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/guidance/IP/344/overview

2.3   Efficacy

2.3.1  A non-randomised study of 101 patients reported cancer-specific survival to be 89%, 100%, and 84% among 30, 36 and 29 patients treated by cryoablation, laparoscopic partial nephrectomy (LPN)  and RFA respectively, at 2 years (significance not stated).

2.3.2  A meta-analysis of prospective and retrospective non-randomised comparative studies and case series, including a total of 1375 patients, reported that repeat ablations were required in significantly fewer patients treated by cryotherapy than RFA (1% [8/600] vs 9% [66/775], p < 0.0001). Furthermore, 5% (31/600) of cryotherapy-treated patients had local tumour progression (defined as radiographic or pathological evidence of residual disease after initial treatment) compared with 12% (100/775), treated by RFA during a mean follow-up of 18.7 months (p < 0.0001).

2.3.3  In a non-randomised comparative study of 264 patients treated by laparoscopic cryotherapy (139 lesions) or by percutaneous RFA (73 lesions), radiographic success (no evidence of central or nodular enhancement) was reported in 90% (125/139) and 85% (62/73) of lesions respectively at 6-month follow-up (p = 0.6183).

2.3.4  In the non-randomised study of 264 patients comparing laparoscopic cryotherapy, versus percutaneous cryotherapy versus RFA, patients returned to work within 18, 6 and 4 days  respectively. The only significant difference was between percutaneous RFA and laparoscopic cryotherapy (p < 0.05). Patient satisfaction did not differ significantly between the groups (not otherwise described).

2.3.5  The Specialist Advisers listed key efficacy outcomes as successful ablation based on radiological criteria, retreatment rates, tumour recurrence, disease-specific survival and overall survival.

2.4   Safety

2.4.1  Haemorrhage requiring transfusion occurred in 28% (5/20) of patients treated by laparoscopic cryotherapy compared with 11% (2/18) treated by percutaneous cryotherapy in a non-randomised study of 37 patients; in 10% (2/20) of patients treated by laparoscopic cryotherapy in a non-randomised study of 66 patients (20 treated by laparoscopic cryotherapy); and in 2% (3/123) and 11% (4/37) in 2 case series of 123 and 37 patients, respectively.

2.4.2  A non-randomised comparative study comparing 29 patients treated by laparoscopic cryoablation, 20 by laparoscopic radial nephrectomy (LRN) and 17 by LPN reported that conversion to open surgery because of intraoperative complications was required in 1 patient in each group. Reasons included splenic haemorrhage, mesenteric artery haemorrhage and the inability to progress due to retroperitoneal scarring (study did not specify which groups these occurred in).

2.4.3  The non-randomised study of 101 patients reported intraoperative pleural injury in 1 patient among 36 in the cryotherapy treatment group. Other postoperative complications in patients in the cryotherapy group included anuria in 2 patients and urine leak, haemothorax, and atelectasis in 1 patient each (no further details provided). 

2.4.4  A case report described acute obstruction and anuria caused by blood clot in the renal pelvis in a patient with a single kidney and chronic renal insufficiency. This was successfully treated by temporary ureteral stent insertion.

2.4.5  Another case report described a patient with a single kidney presenting with left flank pain and fever due to obstruction by urothelial slough 3 months after the procedure. The situation was resolved by ureteroscopic removal of the slough (necrotic tissue without malignancy) and a temporary stent placement.

2.4.6  The Specialist Advisers stated that the most common complication is bleeding. They stated that pancreatic, bowel, ureteric (including pelviureteric junction) injury have occurred but are rare. They considered theoretical adverse events to include the inherent risks of laparoscopic surgery, such as trocar injury, neurapraxia, port site hernia, and CO₂ embolism.

2.5   Other comments

2.5.1  The Committee noted that most reports of laparoscopic cryotherapy for renal cancer included both malignant and benign lesions; and that histology was unknown for many of the lesions treated by the procedure. This made interpretation of the data difficult.

2.5.2  The Committee was advised that the diagnosis of malignancy is typically made by imaging and that histology is generally not available to confirm the diagnosis. This contrasts with treatment by any kind of nephrectomy which provides tissue for histological diagnosis. 

3   Further information

3.1  This guidance is a review of IPG 207 ‘Cryotherapy for renal cancers’ published in 2007.

3.2  For related NICE guidance see www.nice.org.uk

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

March 2011

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 _{It is the responsibility of consultees to accurately cite academic work in order that they can be validated.}