Dear Coroner,

Re: Regulation 28 Report to Prevent Future Deaths – Raymond Lee who died on 14 September 2021.

Thank you for your report to Prevent Future Deaths (hereafter “Report”) dated 15 May 2023 concerning the death of Raymond Lee on 14 September 2021. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Raymond’s family and loved ones. NHS England is keen to assure you that the concerns raised about Raymond’s care have been listened to and reflected upon appropriately.

I am grateful for the further time granted to respond to your Report, and I apologise for any anguish this delay may have caused. We realise our response may form part of the important process of family and friends coming to terms with what has happened to their loved one and appreciate this will have been an incredibly difficult time for them.

As you note in your Report, evidence given at the inquest highlighted the recognised risks and complications related to radiotherapy for oesophageal cancers, notably strictures and perforations.

To support a response, I sought the opinion from our clinical advisor within the Cancer Programme of Care at NHS England and they have also spoken to the relevant professional association lead from the Association of Upper Gastrointestinal Surgery of Great Britain and Ireland (AUGIS). In terms of learning from this case, and from other stenting cases previously reviewed, it is clear that these types of cases are clinically difficult to manage; the NICE guidance is not comprehensive and there does not appear to be a guidelines in place covering these sorts of circumstances (i.e., post radiotherapy). We acknowledge this is something that needs to be addressed and we are actively discussing how best to do this in partnership with AUGIS and NICE. We agree that national, evidence-based advice / guideline would be of benefit to clinicians and patients, and we will work together to develop this in an appropriate way.

I have also received an update from Greater Manchester Integrated Care Board (ICB) regarding this matter. They have advised that the Greater Manchester (GM) Cancer Alliance will be tasking the Oesophago-Gastric (OG) Pathway Board with developing a clear pathway for the management of oesophageal stenting. The Alliance will also be ensuring that outstanding elements of the Multi-Disciplinary Team (MDT) Reform National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

09 August 2023

Programme are actioned within the Cancer Alliance’s programme of work for 2023/24. The ICB has provided NHS England with assurances that they will be following up with GM Cancer Alliance on these actions.

I would also like to provide further assurances on national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around preventable deaths are shared across the NHS at both a national and regional level and this helps us pay close attention to any emerging trends that may require further review and action.

Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.

Dear Ms Mutch,

I write further to your regulation 28 report of 15 May 2023 regarding the death of Raymond Douglas Lee. I would like to extend my sincere condolences to his family.

In your report you explained that oesophageal strictures are a recognised complication of radiotherapy for oesophageal cancers and that there is limited national guidance on how to best treat patients with strictures and limited evidence on which to develop best practice recommendations.

There are a number of causes of oesophageal stricture, including treatment of the oesophagus with radiotherapy. It is not clear from your report when Mr Lee had the radiotherapy in relation to the stricture formation, or the intent of the radiotherapy (ie radical or palliative).

The NICE guideline on oesophago-gastric cancer [NG83] makes recommendations on assessing and managing oesophago-gastric cancer in adults, including radical and palliative treatment and nutritional support.

In section 1.5 of the guideline, on palliative management, we recommend consideration of chemoradiotherapy if surgery is not appropriate and the cancer can be encompassed in a radiotherapy field. If this is not possible, options include stenting or palliative radiotherapy.

Recommendation 1.5.2 says healthcare professionals should discuss the benefits, risks and treatment consequences of each option with the person with oesophageal cancer and those who are important to them (as appropriate). This would include stricture from radiotherapy and the potential for fistula formation or perforation.

Earlier this month we reviewed the evidence and made new recommendations on palliative management of luminal obstruction with no curative intent for adults with oesophageal or oesophago-gastric junctional cancer, including that healthcare professionals should not offer external beam radiotherapy after stenting for people with oesophageal and oesophago- gastric junctional cancer (see recommendation 1.5.11).

You also explained that evidence was given which suggested that dilatation is the best approach initially to treat patients with strictures, but that it carries a risk of perforation,

Page | 2

especially if repeated, and that there was limited evidence on what the optimum number of dilatations were and/or when to stop and move to consider stenting.

NICE has not made recommendations on oesophageal dilatation. The British Society of Gastroenterology has published UK guidelines on oesophageal dilation in clinical practice, however NICE’s guideline committee, when considering evidence regarding interventions such as dilatation, noted that these were seldom used in routine clinical practice and that luminal obstruction was already treated in most centres using expanding metal stents and radiotherapy.

We will log your report and consider further your concerns regarding contraindications for stenting and if we need to strengthen our advice.