Endopyelotomy for pelviureteric junction obstruction (interventional procedures consultation)
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional procedure consultation document
Endopyelotomy 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 (endopyelotomy) aims to widen the renal pelvis by inserting small instruments either up through the urinary tract or down through the skin and into the kidney. The instruments are used to remove the tissue that is causing the obstruction by cutting or burning it away or by applying laser.
The National Institute for Health and Clinical Excellence (NICE) is examining endopyelotomy 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 endopyelotomy 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- The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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 endopyelotomy for pelviureteric junction (PUJ) obstruction is adequate in the short and medium term although there is a risk of of restenosis in the long term. The evidence on safety raises no major concerns. Therefore this procedure may be used provided that normal arrangements are in place for clinical governance, consent and audit.
1.2 This procedure should be carried out only in units with specific expertise in endopyelotomy for PUJ obstruction, by specialist teams who 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, a cutting device (which may be a laser or a diathermy probe, or an endoscopic knife) is inserted into the PUJ area endoscopically via the ureter, or via a percutaneous approach in the flank. Under endoscopic visualisation a full-thickness incision is made, through the wall of the ureter, into the periureteric fat. A stent is inserted across the PUJ, with the aim of maintaining patency, and is 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/IP784overview|
2.3.1 A randomised controlled trial (RCT) of 40 patients treated by laser endopyelotomy versus electrocautery cutting balloon reported a successful outcome (defined as subjective relief or symptom improvement, plus objective relief of obstruction and improvement in glomerular filtration rate) in 85% (17/20) and 65% (13/20) of patients respectively at a mean follow-up of 30 months. (p = 0.14). There was no significant difference between the treatment groups in the success rates for patients with primary or secondary PUJ obstruction (p = 0.38 and p = 0.26 respectively).
2.3.2 A non-randomised controlled trial of 436 patients reported that success (defined as complete symptomatic relief plus resolution or improvement in obstruction on imaging) was achieved in 61% (111/182) of endopyelotomy-treated patients and 82% (144/175) of pyeloplasty-treated patients at a mean follow-up of 3.5 years (significance not stated).
2.3.3 A non-randomised controlled trial of 273 patients reported that success (defined as symptom resolution plus improvement or stability of radiographic parameters) was achieved in 60% of patients in the endopyelotomy group, 89% of the laparoscopic pyeloplasty group, and 100% of the robotically assisted pyeloplasty group at a mean follow-up of 20 months (absolute numbers and significance not stated). Multivariate analysis (excluding the robotically assisted group) showed that endopyelotomy (compared with laparoscopic pyeloplasty) was an independent predictor of treatment failure (hazard ratio 3.16; 95% confidence interval 1.70 to 5.86, p < 0.001).
2.3.4 In the non-randomised controlled trial of 436 patients, the 10-year estimated recurrence-free survival was 41% (n = 8) in the endopyelotomy group and 75% (n = 21) in the pyeloplasty group.
2.3.5 The Specialist Advisers listed key efficacy outcomes as short-term relief of pain, resolution of symptoms and normalisation of renographic obstruction, preservation of renal function and no restenosis in the long term.
2.4.1 The RCT of 40 patients treated by laser endopyelotomy versus electrocautery cutting balloon reported no significant difference in the rate of overall complications (not otherwise defined) between treatment groups (10% [2/20] and 25% [5/20] respectively; p = 0.20). The non-randomised controlled trial of 436 patients reported that the rate of overall complications was not significantly different between the endopyelotomy group (11% [25/225]) and the pyeloplasty group (open or laparoscopic) (8% [17/211]) (p = 0.33) at a mean follow-up of 3.5 years.
2.4.2 Bleeding requiring transfusion occurred in 1% (3/225) of patients in the endopyelotomy group and 1% (2/211) of patients in the pyeloplasty group in the non-randomised controlled trial of 436 patients (significance not stated). Haemorrhage requiring electrocoagulation occurred in 1% (4/320) and haemorrhage requiring transfusion in 1% (2/212) of patients (1 patient required further intervention [not otherwise stated]) in case series of 320 and 212 patients treated by endopyelotomy, respectively.
2.4.3 PUJ rupture during drain insertion occurred in 1% (4/320) of patients and debris obstructing the PUJ was noted in 2% (6/320) of patients in the case series of 320 patients. Ureteral avulsion requiring an open procedure was reported in 1 of 212 patients in a case series.
2.4.4 One case report described a patient who developed renal atrophy, renal hypertension, perinephric fibrosis and calcification, vena caval stenosis and renal vein obstruction after endopyelotomy: the patient needed a nephrectomy 8 years later. The primary event was thought to have been development of a subcapsular haematoma after endopyelotomy. A second case report described ureteral intussusception following endopyelotomy at 3-month follow-up, treated by pyeloplasty reconstruction (not otherwise described).
2.4.5 Reoperation (repeat endopyelotomy, open pyeloplasty or nephrectomy) was required in 10% (33/320) of patients in the case series of 320 patients. In the case series of 212 patients, repeat endopyelotomy was required in less than 1% (1/212), secondary intervention by pyeloplasty in 8% (18/212), ureterocalicostomy in 2% (4/212), and ileal interposition in 1 patient.
2.4.6 The Specialist Advisers listed adverse events as haemorrhage, stent-related problems and aorto-ureteral fistula. They considered theoretical adverse events to include failure/restenosis, infection, perforation and fibrosis.
2.5 Other comments
2.5.1 The Committee was advised that endopyelotomy for PUJ obstruction is used less frequently than in the past 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 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