Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2023-0151, written 15 May 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 15 May 2023 |
|---|---|
| Reference | 2023-0151 |
| Deceased | Raymond Lee |
| Coroner | Alison Mutch |
| Coroner area | Manchester South |
| Category | Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | The Christie NHS Foundation Trust · Stockport NHS Foundation Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 2 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS
REGULATION 28 REPORT TO PREVENT FUTURE DEATHS
THIS REPORT IS BEING SENT TO: NHS England and NICE (National Institute
for Health and Care Excellence)
1 CORONER
I am Alison Mutch, Senior Coroner, for the Coroner Area of Greater Manchester
South
2 CORONER’S LEGAL POWERS
I make this report under paragraph 7, Schedule 5, of the Coroners and Justice
Act 2009 and regulations 28 and 29 of the Coroners (Investigations) Regulations
2013
3
INVESTIGATION and INQUEST
On 16th September 2021 I commenced an investigation into the death of
Raymond Lee. The investigation concluded on the 19th January 2023 and the
conclusion was one of Narrative: Died from complications of treatment for
oesophageal cancer and a subsequent oesophageal stricture. The medical
cause of death was 1a) Gastrointestinal Haemorrhage; 1b) Aorta-
oesophageal fistula on the background of oesophageal stent; 1c)
Oesophageal cancer treated by radiotherapy
4 CIRCUMSTANCES OF THE DEATH
Raymond Douglas Lee had oesophageal cancer. Due to his underlying health,
he was treated with radiotherapy- other treatments were not felt to be suitable.
He developed an oesophageal stricture as a consequence of the radiotherapy
treatment. Dilatation procedure did not lead to an improvement. A biodegradable
stent was inserted to try to improve the position. He was in significant pain as a
consequence of the stent. Pain is a recognised complication of stenting in these
circumstances. He was admitted to Stepping Hill Hospital on 13th September
2021 following episodes of bleeding. A gastroscopy on 14th September 2021
confirmed that the bleeding was from the oesophagus - from an
aorta/oesophageal fistula. On the balance of probabilities, the stent had
contributed to the development of the fistula. Raymond Douglas Lee continued
to deteriorate and died at Stepping Hill Hospital on 14th September 2021.
1
5 CORONER’S CONCERNS
During the course of the inquest the evidence revealed matters giving rise to
concern. In my opinion there is a risk that future deaths will occur unless action
is taken. In the circumstances it is my statutory duty to report to you.
The MATTERS OF CONCERN are as follows. –
The inquest heard evidence that oesophageal strictures are a recognised
complication of radiotherapy for oesophageal cancers. The implications of them
are significant for patients as they can lead to aspiration and as well as
significantly impact quality of life. At this time there is only very limited national
guidance on how to best treat patients with strictures and limited evidence on
which to develop best practice. The evidence given was that careful dilatation by
an experienced practitioner was the best approach initially. However, dilatation
particularly repeated dilatation carried risk of perforation and needed to be seen
as something that could not be continued indefinitely. However, there was
limited evidence on what the optimum number of dilatations were and/or when
to stop and move to consider stenting.
The inquest heard that stenting of patients in these circumstances has a limited
body of evidence regarding the risk. The inquest highlighted that perforation
may be a risk in some cases where a stent is used and that needed to be
factored into any decision to use a stent.
6 ACTION SHOULD BE TAKEN
In my opinion action should be taken to prevent future deaths and I believe you
have the power to take such action.
7 YOUR RESPONSE
You are under a duty to respond to this report within 56 days of the date of this
report, namely by 10th July 2023. I, the coroner, may extend the period.
Your response must contain details of action taken or proposed to be taken,
setting out the timetable for action. Otherwise you must explain why no action is
proposed.
8 COPIES and PUBLICATION
I have sent a copy of my report to the Chief Coroner and to the following
on behalf of the Family; 2)
Interested Persons namely 1)
3) The Christie NHS Foundation Trust; and 4) Stockport NHS
Foundation Trust, who may find it useful or of interest.
I am also under a duty to send the Chief Coroner a copy of your response.
2
The Chief Coroner may publish either or both in a complete or redacted or
summary form. He may send a copy of this report to any person who he
believes may find it useful or of interest. You may make representations to me,
the coroner, at the time of your response, about the release or the publication of
your response by the Chief Coroner.
9
Alison Mutch
HM Senior Coroner
15.05.2023
3
2 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
Alison Mutch
Manchester South Coroner’s Court
1 Mount Tabor Street
Stockport
SK1 3AG
National Medical Director
NHS England
Wellington House
133-155 Waterloo Road
London
SE1 8UG
09 August 2023
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
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.
Yours sincerely,
National Medical Director
2nd Floor
2 Redmond Place
London
E20 1JQ
United Kingdom
28 July 2023
Alison Mutch
Coroner’s Court
1 Mount Tabor Street
Stockport
SK1 3AG
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,
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.
Yours sincerely,
Chief executive
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