Electrocautery cutting balloon treatment for pelviureteric junction obstruction (interventional procedures consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Electrocautery cutting balloon treatment for pelviureteric junction obstruction
Pelviureteric junction obstruction is a condition caused by a narrowing of the funnel-shaped part of the kidney (known as the renal pelvis) where urine collects before being carried to the bladder by tubes called ureters. The obstruction may cause episodes of loin pain and/or nausea and vomiting, urinary infections and kidney stones. In some patients the condition could also affect the normal function of the kidney.
This procedure (electrocautery cutting balloon treatment) aims to widen the renal pelvis by inserting a catheter with a balloon and wire into the urinary tract. The wire is used to cut away the tissue that is causing the obstruction.
The National Institute for Health and Clinical Excellence (NICE) is examining electrocautery cutting balloon treatment for pelviureteric junction obstruction 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 electrocautery cutting balloon treatment for pelviureteric junction 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:
- 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- The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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).
NICE is committed to promoting through its guidance race and disability equality and 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 guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. 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: 23 September 2009
Target date for publication of guidance: December 2009
1 Provisional recommendations
1.1 Current evidence on the efficacy of electrocautery cutting balloon treatment for pelviureteric junction (PUJ) obstruction is inadequate and there is a risk of restenosis in the long term. The evidence on safety raises some concern about the risk of bleeding. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to undertake electrocautery cutting balloon treatment for PUJ obstruction should take the following actions.
- Inform the clinical governance leads in their Trusts.
- Ensure that patients and their parents/carers understand that there is a risk of bleeding as a result of the procedure and a risk of restenosis in the longer term, and provide them with clear written information. In addition, the use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/IPGXXXpublicinfo). [[details to be completed at publication]]
- Audit and review clinical outcomes of all patients having electrocautery cutting balloon treatment for PUJ obstruction (see section 3.1).
1.3 Patient selection and treatment should be carried out only in units that can offer a range of procedures including laparoscopic pyeloplasty.
2 The procedure
2.1 Indications and current treatments
2.1.1 PUJ obstruction is a congenital or acquired stenosis of the junction between the renal pelvis and the ureter, which inhibits normal urine flow. It can cause chronic or recurrent flank pain as well as urinary tract infections.
2.1.2 Conservative treatment may include long-term use of low-dose antibiotics. Current surgical options to reconstruct and normalise the anatomy of the PUJ include open or laparoscopic pyeloplasty (with or without robotic assistance) and endopyelotomy.
2.2 Outline of the procedure
2.2.1 The aim of the procedure is to widen the abnormally narrowed part of the PUJ. With the patient under general anaesthesia and using fluoroscopic guidance, a device containing a monopolar diathermy wire on the surface of a low-pressure tamponade balloon is inserted through the ureter and into the PUJ. The balloon is partially inflated to determine the area of stenosis (seen as a waist in the balloon) and fix it in position for incision. The diathermy wire incises the target area of the PUJ, through the wall of the ureter, into the periureteric fat. The balloon is fully inflated to apply pressure (tamponade) following incision to promote haemostasis. A stent is inserted across the PUJ and removed after several weeks.
|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/IIP776overview|
2.3.1 A randomised controlled trial (RCT) of 40 patients treated by electrocautery cutting balloon versus laser endopyelotomy reported a ‘successful outcome’ (defined as subjective relief or symptom improvement plus objective relief of obstruction and improvement in glomerular filtration rate) in 65% (13/20) and 85% (17/20) of patients respectively at a mean follow-up of 30 months (p = 0.14).
2.3.2 A non-randomised controlled trial of 64 patients reported no significant difference in success rate (defined as relief of symptoms, decreased caliectasis, and diuretic renography half-time values indicating absence of obstruction) between patients treated by electrocautery cutting balloon (78% [21/27]) and those treated by laser endopyelotomy (74% [26/35]) at a mean follow-up of 76 months.
2.3.3 A non-randomised controlled trial of 149 patients reported ‘subjective success’ (defined as a 50% improvement in preoperative discomfort) in 85% of 52 patients with primary PUJ obstruction treated by electrocautery cutting balloon and 90% of 40 patients treated by antegrade electrode ablation endopyelotomy at a mean follow-up of 16 months (absolute numbers and significance not stated).
2.3.4 A non-randomised controlled trial of 64 patients (17 treated by electrocautery cutting balloon) reported no significant difference in the proportion of patients satisfied with their procedure after electrocautery cutting balloon treatment (73%), antegrade endopyelotomy (100%) or retrograde endopyelotomy (86%) (p = 0.09) (mean follow-up 67 months).
2.3.5 The non-randomised controlled trial of 64 patients reported no significant difference in re-operation rates following electrocautery cutting balloon treatment (6% [1/17]), antegrade endopyelotomy (0% [0/18]) or retrograde cold knife endopyelotomy (17% [5/29]) (p = 0.13) (mean follow-up 67 months).
2.3.6 The Specialist Advisers listed key efficacy outcomes as short-term pain relief, resolution of obstruction on imaging and no restenosis in the long term.
2.4.1 Bleeding requiring transfusion and embolisation of a lower-pole vessel was reported in 7% (2/27) of patients in the electrocautery cutting balloon group compared with 0% (0/37) of patients in the laser endopyelotomy treatment group in the non-randomised controlled trial of 64 patients (p = 0.13). Ureteral bleeding requiring transfusion was reported in 4% (3/76) of patients in a case series of 76 patients treated by electrocautery cutting balloon for PUJ obstruction; embolisation of a lower-pole artery was required in 2 patients. Haematuria (managed conservatively) was reported in 15% (3/20) of patients treated by electrocautery cutting balloon at follow-ups ranging from 2–5 days in the RCT of 40 patients.
2.4.2 A case report of 2 patients described 1 patient with a large perirenal haematoma caused by incision of an aberrant renal artery during electrocautery cutting balloon treatment, which was ligated at open surgery, and 1 patient who developed a pseudoaneurysm of an aberrant lower-pole artery, which was embolised .
2.4.3 One case report described a broken cutting balloon wire in the PUJ, which had become calcified and required
ureteroscopically-guided laser ablation. Balloon rupture was reported in 1 patient in the RCT of 40 patients.
2.4.4 The Specialist Advisers listed adverse events as infection and need for transfusion.
2.5 Other comments
2.5.1 The Committee was advised that electrocautery cutting balloon treatment for PUJ obstruction is used infrequently because of the increased use of laparoscopic pyeloplasty, but that it may have a particular role in the management of restenosis.
3 Further information
3.1 This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.
3.2 For related NICE guidance see www.nice.org.uk
Chairman, Interventional Procedures Advisory Committee
Personal data will not be posted on the NICE website. In accordance with the Data Protection Act names will be anonymised, other than in circumstances where explicit permission has been given.
It is the responsibility of consultees to accurately cite academic work in order that they can be validated.
This page was last updated: 30 March 2010