Interventional procedure consultation document

Stent insertion for bleeding oesophageal varices

Stopping enlarged veins in the oesophagus from bleeding by inserting an expandable mesh tube

People who drink heavily or who have hepatitis C may develop liver cirrhosis (scarring). This can cause bleeding arising from swollen veins in the gullet (oesophagus), which is potentially life threatening. This procedure involves temporary insertion of a tube-shaped mesh covered in plastic (called a stent) into the oesophagus. The stent is expanded to the width of the gullet so that it presses against the veins with the aim of stopping the bleeding. The stent is removed within 2 weeks.

The National Institute for Health and Clinical Excellence (NICE) is examining stent insertion for bleeding oesophageal varices 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 stent insertion for bleeding oesophageal varices.

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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 21 January 2010

Target date for publication of guidance: April 2010

1   Provisional recommendations

1.1  Current evidence on stent insertion for bleeding oesophageal varices is from small numbers of patients, but shows no major safety concerns. There is evidence to show that this procedure is efficacious in selected patients in whom other methods of treatment have failed to control bleeding. Therefore this procedure may be used provided that normal arrangements are in place for clinical governance, consent and audit.

2   The procedure

2.1  Indications and current treatments

2.1.1  Oesophageal varices are enlarged veins within the lower oesophagus and the oesophagogastric junction which develop in patients with portal hypertension, often as a result of cirrhosis. Bleeding from varices has a significant risk of death and the risk of re-bleeding is high.

2.1.2  The management of bleeding oesophageal varices commonly requires blood transfusion: measures aimed at arresting the bleeding include vasoactive medication, balloon tamponade, endoscopic variceal band ligation or sclerotherapy. In patients with refractory bleeding, transjugular intrahepatic portosystemic shunts (TIPSS), and shunt or devascularisation surgery, may be required.

2.2   Outline of the procedure

2.2.1  The aim of this procedure is to apply pressure to the bleeding oesophageal varices to induce haemostasis.

2.2.2  The procedure is usually carried out following diagnostic endoscopy. A purpose-made metal stent with a plastic coating, supplied on a delivery system, is inserted with the aim of compressing the bleeding varices in the oesophageal wall. Appropriate positioning of the stent may be confirmed endoscopically or by chest X-ray.

2.2.3  The stent maintains a patent oesophageal lumen for passage of food, saliva and other fluids. It is left in position for up to 2 weeks and is then removed endoscopically.

2.2.4  Further procedures, such as TIPPS or surgery may be done to minimise the risk of further bleeds.

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/690/overview

2.3   Efficacy

2.3.1  Case series of 34 and 20 patients reported that stent insertion stopped the bleeding in all patients and that no re-bleeding occurred in any patients (60-day follow-up).

2.3.2  A case series of 10 patients reported immediate control of bleeding in 78% (7/9) of patients who had successful stent insertion (stent insertion was unsuccessful in 1 patient). Re-bleeding which was successfully treated by TIPSS occurred in 1 patient.

2.3.3  Case series of 34, 20 and 10 patients treated with stent insertion reported 10, 2 and 5 deaths respectively during follow-up of between 42 and 60 days. Of the 17 deaths, 2 resulted from exsanguination, 1 was caused by multi-organ failure and failure to control the bleeding, and the remainder were as a result of hepatic or multi-organ failure.

2.3.4  The case series of 34 patients reported that 32% (11/34) of patients required endoscopic band ligation, 24% (8/34) required radiologic TIPSS insertion and 15% (5/34) required laparoscopic azygoportal disconnection after stent removal (timing of events not stated).

2.3.5  The case series of 20 patients reported that after stent removal 25% (5/20) of patients required TIPSS insertion, 25% (5/20) required laparoscopic azygoportal disconnection and 20% (4/20) required embolotherapy with sclerosing agents combined with coils (timing of events not stated).

2.3.6  The Specialist Advisers listed key efficacy outcomes as control of bleeding, reduction in risk of re-bleeding, avoidance of using blood products and survival.

2.4   Safety

2.4.1  A case report described acute bronchial obstruction at day 6 caused by stent-related compression of the left main bronchus (confirmed by computed tomography scan) which was relieved by stent removal.

2.4.2  Migration of the stent into the stomach was reported in 21% (7/34) of patients during 60-day follow-up in the case series of 34 patients. All stents were successfully repositioned within 24–48 hours. In the case series of 20 patients, stent migration into the stomach was reported in 25% (5/20) of patients: all stents were repositioned endoscopically. Three of the 5 migrations were in the first 5 patients in the series.

2.4.3  Slight oesophageal ulceration at the distal end of the stent was reported in 1 patient within 60-day follow-up in the case series of 34 patients.

2.4.4  The Specialist Advisers listed adverse events reported in the literature / from own experience as mucosal trauma on withdrawal, oesophageal perforation, oesophageal pressure ulceration, fistula formation, worsening of bleeding, failure of removal of device and aspiration pneumonia. They considered theoretical adverse events to include dysphagia.

3   Further information

3.1  This procedure is a review of ‘Stent insertion for bleeding oesophageal varices’ NICE interventional procedures guidance 265 (2008).

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

December 2010

_{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.}