Interventional procedure consultation document

Endoscopic radiofrequency ablation for gastro-oesophageal reflux disease

Treating gastro-oesophageal reflux disease using electrical heat energy

Gastro-oesophageal reflux disease means that the acidic stomach contents travel back up the oesophagus It is also known as acid reflux (heartburn) and causes an acid taste in the mouth. In severe cases it can cause complications such as cough and problems with swallowing.  It happens when the ring of muscle (sphincter)  at the top of the stomach  isn’t working properly.

In endoscopic radiofrequency ablation for gastro-oesophageal reflux disease, an endoscope (a tube containing a camera and other instruments) is inserted through the mouth and down the oesophagus.  An instrument then creates heat in the tissues which leads to scar formation beneath the lining of the oesophagus where it joins the stomach.  The aim is to reduce the tendency of the stomach contents to reflux.

The National Institute for Health and Care Excellence (NICE) is examining endoscopic radiofrequency ablation for gastro-oesophageal reflux disease 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 endoscopic radiofrequency ablation for gastro-oesophageal reflux disease.

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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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, advance equality of opportunity, 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: 27 May 2013

Target date for publication of guidance: 28 August 2013

1                      Provisional recommendations

1.1                  The evidence on the safety of endoscopic radiofrequency ablation for gastro-oesophageal reflux disease (GORD) is adequate in the short and medium term but there is uncertainty about longer‑term outcomes. With regard to efficacy, there is evidence of symptomatic relief but objective evidence on reduction of reflux is inconclusive. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2                  Clinicians wishing to undertake endoscopic radiofrequency ablation for GORD should take the following actions.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients understand the uncertainty about the procedure’s safety and efficacy and provide them with clear written information. In addition, the use of NICE’s information for the public [[URL to be added at publication]] is recommended.
• Audit [URL to audit tool to be added at publication] and review clinical outcomes of all patients having endoscopic radiofrequency ablation for gastro-oesophageal reflux disease (see section 3.1).

1.3                  Future review of the guidance might consider evidence from research that includes objective outcome measures such as oesophageal pH, long‑term follow‑up data, comparison with Nissen fundoplication, information about patient selection and further insight into the mechanism of action of the procedure.

2                      Indications and current treatments

2.1                  GORD is a common problem caused by disturbance of the sphincter function at the lower end of the oesophagus. Symptoms include heartburn, regurgitation, chest pain, nausea, respiratory difficulties and dysphagia. If untreated, complications such as Barrett's oesophagus or oesophageal stricture can develop.

2.2                  Lifestyle modification and gastric acidity‑lowering medication can help to improve symptoms. Patients who have refractory symptoms, who develop complications despite medication or who develop intolerance to medication may be considered for anti‑reflux surgery. Most commonly this is laparoscopic fundoplication but alternative endoscopic techniques have also been used.

3                      The procedure

3.1                  The aim of endoscopic radiofrequency ablation for GORD is to reduce symptoms. It is unclear whether symptom relief is mediated solely by narrowing the gastro-oesophageal junction or by reducing sensitivity to acid reflux by denervation and other mechanisms.

3.2                  The procedure is usually performed with the patient under sedation. The oesophageal diameter is measured endoscopically and a guidewire with a flexible tip is passed through the endoscope and left in the stomach; the endoscope is removed. A specially designed radiofrequency balloon catheter, consisting of an inflatable balloon-basket with 4 electrode needle sheaths, is inserted through the mouth over the guidewire and advanced to the gastro-oesophageal junction. The balloon is inflated to the diameter of the oesophagus and the electrodes are deployed to penetrate through the mucosa and deliver radiofrequency energy to the musculature of the lower oesophageal sphincter and the gastric cardia, creating small lesions. Several cycles of approximately 1 minute of radiofrequency energy are delivered. As the lesions heal, the tissue contracts and thickens, narrowing the oesophageal sphincter.

4                      Efficacy

This section describes efficacy 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.

4.1                  A systematic review of 20 studies including 1441 patients reported oesophageal acid exposure from 11 studies (364 patients). The mean percentage of time that pH was less than 4 decreased from 10% at baseline to 7% (p=0.0003) at mean 12‑month follow‑up. A crossover RCT of 22 patients comparing endoscopic radiofrequency ablation against sham reported that there were no significant changes in oesophageal acid exposure at 3 or 6‑month follow‑up. An RCT of 43 patients reported abnormal oesophageal acid exposure in 94% (17/18) of patients treated by radiofrequency ablation and in 75% (9/12) of patients treated with proton pump inhibitors (PPIs) alone at 6‑month follow‑up (p=0.27).

4.2                  A non-randomised comparative study of 126 patients treated by radiofrequency ablation or endoluminal full-thickness plication reported that the percentage of time the pH was less than 4 reduced from 11% at baseline to 9% at mean 5‑month follow‑up (not significant) and from 10% at baseline to 6% at mean 8‑month follow-up (p=0.05), respectively.

4.3                  The RCT of 43 patients reported oesophagitis (diagnosed by endoscopy) in 53% (10/19) of patients treated by radiofrequency ablation and 54% (7/13) of patients treated with PPIs alone at 6‑month follow‑up (p=0.97).

4.4                  The systematic review of 20 studies including 1441 patients reported the mean gastro-oesophageal reflux disease health-related quality of life score in 9 studies (433 patients), which improved from 26.1 at baseline to 9.3 after treatment (p=0.0001, mean follow‑up 20 months). In the same review, 6 studies with 299 patients reported the mean SF‑36 (physical) score improved from 36 to 46 points at mean 10‑month follow‑up (p=0.0001). Five studies (264 patients) reported that the mean SF‑36 (mental) score improved from 47 to 55 at mean 10‑month follow‑up (p=0.0015).

4.5                  The systematic review of 20 studies reported a pooled heartburn score from 9 studies (525 patients) of 3.6 at baseline and 1.2 at mean 24‑month follow‑up (p=0.0001; lower scores indicate less severe symptoms). The crossover RCT of 22 patients comparing radiofrequency ablation against sham reported a significant improvement in symptom score at 3 months compared with baseline in the active treatment group (from 14.7 to 8.3, p<0.005) but not in the sham group (from 16.1 to 15.6; not significant). When patients in the sham group were subsequently treated by radiofrequency ablation, the symptom score significantly improved to 7.2 (p<0.05) at 3‑month follow‑up. The RCT of 43 patients treated by endoscopic radiofrequency ablation or PPIs alone reported symptoms fewer than 3 times a week in 80% (16/20) and 40% (6/15) of patients respectively at 6‑month follow‑up (p=0.01). At 12‑month follow‑up, 69% (11/20) of patients in the radiofrequency ablation group had symptoms fewer than 3 times a week compared with 62% (8/14) of patients in the control group (p=0.71). There were no statistically significant differences in the individual symptom scores.

4.6                  The crossover RCT of 22 patients reported no significant change in medication use from baseline in either group at 6‑month follow‑up. The RCT of 43 patients reported that 13% (3/23) and 17% (4/23) of patients in the radiofrequency ablation group at 6 and 12 months respectively were able to stop PPIs completely compared with none of the control patients.

4.7                  The Specialist Advisers listed key efficacy outcomes as long‑term objective evidence (pH studies), long‑term symptomatic control, quality of life and decreasing or stopping PPIs.

5                      Safety

This section describes 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.

5.1                  One case series reported 3 deaths and 22 complications overall (not otherwise defined) in patients treated by radiofrequency ablation for gastro-oesophageal disease (number of procedures to which these events relate not known).

5.2                  Mucosal bleeding was reported in 3% (3/90) of patients in a case series of 90 patients.. Superficial mucosal injury was reported in 2% (2/90) of patients in the same study. All these complications resolved within 1 week of the procedure.

5.3                  Prolonged gastroparesis was reported in 1 patient in a case series of 56 patients: this resolved within 8 weeks.

5.4                  The Specialist Advisers listed oesophageal perforation as an additional adverse event reported in the literature. The Specialist Advisers considered theoretical adverse events to include an increased risk of oesophageal cancer in the long term.

6                      Committee comments

6.1                  The Committee noted that the mechanism of action of endoscopic radiofrequency ablation for GORD is uncertain. It was advised that symptoms may improve as a result of denervation caused by the procedure; the resulting insensitivity of the lower oesophagus to reflux could lead to complications in the long term.

7                      Further information

7.1                  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.

7.2                  This guidance is a review of ‘Endoscopic radiofrequency ablation for gastro-oesophageal reflux disease’ NICE interventional procedure guidance 292 (2009).

7.3                  For related NICE guidance see the NICE website.

Bruce Campbell

Chairman

Interventional Procedures Advisory Committee

April 2013