Interventional procedure consultation document - laparoscopic partial nephrectomy

NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE

Interventional Procedure Consultation Document

Laparoscopic partial nephrectomy

The National Institute for Health and Clinical Excellence is examining laparoscopic partial nephrectomy 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 laparoscopic partial nephrectomy.

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 preliminary recommendations
  • the identification of factual inaccuracies
  • additional relevant evidence.

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  • The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland.

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: 23 August 2005
Target date for publication of guidance: November 2005


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 laparoscopic partial nephrectomy suggests that it is safe and efficacious when undertaken by surgeons with special expertise in this technique. Surgeons undertaking laparoscopic partial nephrectomy should have specific training and regular experience in laparoscopic renal surgery.

1.2 Clinicians wishing to undertake this procedure should ensure that patients fully understand the risks, including that of serious haemorrhage. In addition, use of the Institute's Information for the public is recommended.
1.3

Clinicians should audit and review their results. The British Association of Urological Surgeons are running an audit on laparoscopic nephrectomies and clinicians are encouraged to enter all patients undergoing laparoscopic partial nephrectomy onto this database (www.baus.org.uk/Display.aspx?item=326).


2 The procedure
2.1 Indications
2.1.1 Indications for laparoscopic partial nephrectomy include: a solid renal tumour in a patient with a solitary kidney or compromised contralateral kidney; bilateral renal tumours; and small localised renal tumours in patients with a normal contralateral kidney. Most solid renal tumours are renal cell carcinomas but a small proportion of them are benign tumours, such as oncocytomas.
2.1.2 Some small tumours may not be suitable for laparoscopic partial nephrectomy because of their position (centrally located lesions are more difficult to remove than peripheral lesions).
2.1.3

The standard treatment for these indications is open partial nephrectomy.

2.2 Outline of the procedure
2.2.1 A laparoscopic partial nephrectomy is performed under general anaesthetic, using a transperitoneal or retroperitoneal approach. In the transperitoneal approach, the abdomen is insufflated with carbon dioxide and three or four small abdominal incisions are made. In the retroperitoneal approach, a small incision is made in the back and a dissecting balloon is inserted to create a retroperitoneal space. After insufflation with carbon dioxide, two or three additional small incisions are made in the back. The renal vessels are identified and either controlled using vessel loops or clamped, and the kidney is mobilised to allow exposure of the lesion. A laparoscopic ultrasound probe may be used to determine the line of incision and depth of tumour involvement. The specimen is enclosed in a bag and retrieved through an expanded port.
2.2.2

Hand-assisted laparoscopic partial nephrectomy allows the surgeon to place one hand in the abdomen while maintaining the pneumoperitoneum required for laparoscopy. An additional small incision is made that is just large enough for the surgeon's hand and an airtight 'sleeve' device is used to form a seal around the incision.

2.3 Efficacy
2.3.1

One non-randomised comparative study of 200 patients reported a median hospital stay of 2 days for laparoscopic partial nephrectomy compared with 5 days for open partial nephrectomy (p < 0.001). A second non-randomised comparative study, which involved 49 patients, reported a mean hospital stay of 3 days for the laparoscopic procedure compared with 6 days for open surgery (p < 0.0002). The first of these studies also reported a significantly shorter median convalescence time for laparoscopic partial nephrectomy compared with open partial nephrectomy (4 weeks versus 6 weeks, p < 0.001).

2.3.2 In one non-randomised comparative study, positive surgical margins (with tumour involvement) were reported after 3% (3/100) of laparoscopic partial nephrectomies compared with 0% (0/100) of open partial nephrectomies. In a second non-randomised comparative study, positive surgical margins were reported in 0% (0/27) of laparoscopic procedures and 5% (1/22) of open procedures. Two case series reported positive surgical margins in 3% (1/37 and 3/100) of cases.
2.3.3 Three studies reported tumour recurrence rates of 0% (0/100), 0% (0/79) and 4% (2/48) after mean follow-up periods of 15 months, 20 months and 38 months, respectively. For more details, refer to the sources of evidence (see Appendix).
2.3.4

The Specialist Advisors noted concern about the possibility of incomplete cancer clearance.

 

2.4 Safety
2.4.1

Six studies reported urine leakage as a complication, affecting between 2% (2/100) and 9% (5/53) of patients. In three studies, the rate of postoperative haemorrhage was 2% (4/200, 2/100 and 1/53 of patients), and the rate of intraoperative haemorrhage ranged from 3% (3/100) to 8% (4/53). Other complications included renal failure, damage to the ureter, bowel and blood vessels, and urinary tract infection. For more details, refer to the sources of evidence (see Appendix).

2.4.2 The main safety concerns listed by the Specialist Advisors were intraoperative and postoperative bleeding, and urine leak.
2.5 Other comments
2.5.1 The Committee noted that the published evidence came from highly specialised units experienced in laparoscopic renal surgery, where clinicians have undertaken a large number of laparoscopic partial nephrectomies.

Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
DATE

Appendix: Sources of evidence

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

  • Interventional procedure overview of laparoscopic partial nephrectomy, April 2005

Available from: www.nice.org.uk/ip308overview

This page was last updated: 04 February 2011