Lexie Harrison

The Leeds Teaching Hospitals INHS|

NHS Trust

contact:
Date: 12015
Our ref: ey

Chief Medical Officer
Ms Melanie J Williamson Trust Headquarters
Assistant Coroner St James's University Hospital
West Yorkshire (Eastern) Beckett =
Coroner's Office LS9 7TF

71 Northgate

Wakefield Direct Line: (0113) 2065214

WF1 3BS Fax: (0113) 2067007
E-Mail:

PA:

www.leedsth.nhs.uk

Dear Ms Williamson
INQUEST TOUCHING THE DEATH OF LEXIE LOUISE HARRISON (Deceased)

| refer to your correspondence of 20th February 2015, received on 27th February, regarding
the inquest touching the death of Lexie Louise Harrison and the Regulation 28 Report to
Prevent Future Deaths in respect of this case.

I can confirm that the contents of your Regulation 28 Report have been shared with the
relevant staff to enable us to provide you with a comprehensive response.

We have considered the contents very carefully and the responses to the matters of concern
you have raised in the report are detailed below.

In your report you highlight that

(1) Birmingham Children’s Hospital NHS Foundation Trust has a policy in place and/or
guidelines dealing with paediatric endoscopy procedures for the banding of an
oesophageal varix/oesophageal varices (‘the procedure’). Neither Sheffield Children’s
NHS Foundation Trust nor Leeds Teaching Hospitals NHS Trust has such a policy
and/or guideline. Both of the latter Trusts have undertaken the said procedure for many

years.

The management of bleeding oesophageal varices is a medical emergency and each of the
three Paediatric Liver Centres in the UK (Leeds, Birmingham and London) have guidelines for
the management of this emergency. As you will recall, the Leeds version of these guidelines
was produced in evidence at the Inquest and includes recommendations about resuscitating
the child; when to use antibiotics; when to pass a Sengstaken tube; the need to go to theatre
for the oesophageal varices to be banded by a trained operator and, the post-operative
management of the patient which included the use of an acid suppressing agent (omeprazole)
and an antacid (sucralfate). cont/d..

Chairman Dr Linda Pollard CBE JP DL Chief Executive Julian Hartley

The Leeds Teaching Hospitals incorporating: Chapel Allerton Hospital, Leeds Dental Institute, Leeds Children’s Hospital,
Seacroft Hospital, St James’s University Hospital, The General Infirmary at Leeds, Wharfedale Hospital, Leeds Cancer Centre

Page 2

These guidelines are very similar to those used in both London and Birmingham and we have
shared the Leeds guidelines with our referring Trusts including Sheffield Children's Hospital.

However, Lexie underwent prophylactic banding of her varices i.e. banding before they had
bled. Currently there are no national guidelines for this procedure in children. The procedure

decreases the risk of spontaneous oesophageal bleeding. From 2006, the three Children's
Liver Centres in the UK undertook a study t assess the benefits of prophylactic banding
of oesophageal varices in children. from Birmingham was the chief investigator
for this study. Of the 65 children recruited to the study only 22 had varices large enough to be
randomised into the banding or non-banding arms of the study. Results were assessed after

banding episode. The numbers in this study were too small to provide evidence for the
efficacy of prophylactic banding, although it was felt that that the procedure was well tolerated.
This study is published in abstract form.

endoscopy. They apply the same conditions as in the study which graded oesophageal
varices as small - occupying less than a third of the radius of the oesophagus during maximum
insufflation; moderate - occupying between a third and two thirds of the radius of the
oesophagus; and large - occupying greater than two thirds of the radius of the oesophagus.
As in the study only those with large oesophageal varices would be banded.

In Leeds, following considerable deliberation of the evidence available, the clinical team
concluded that they should only offer prophylactic banding to children over 10 years of age

There is no written protocol describing how to perform a banding procedure although it is
described in textbooks. Trainees are taught this procedure as part of their education towards
a certificate of completion of training in Paediatric Hepatology and in Paediatric
Gastroenterology.

Point 2 of your report raises concerns that: /
(2) There is no standardisation of Practices, (either locally or nationally), adopted by
Consultants when undertaking the said procedure, by reason predominantly of there
being no national policy and/or guideline in relation thereto.

You have listed a number of points that a national policy or guideline should address namely:
(a) Precise definitions of the grades of oesophageal varices;
(b) Which grades of varies should be subject to banding and which should not;
(c) Those patients who are deemed Suitable for placing on a banding programme and

those who are not:

Chairman Dr Linda Pollard CBE JP DL Chief Executive Julian Hartley

The Leeds Teaching Hospitals incorporating: Chapel Alierton Hospital, Leeds Dental Institute, Leeds Children’s Hospital,
Seacroft Hospital, St James’s University Hospital, The General Infirmary at Leeds, Wharfedale Hospital, Leeds Cancer Centre

Page 3

(d) Once a patient is placed on a banding programme, the assessment process to be
adopted prior to the said patient undergoing each procedure;

(e) Post endoscopy care, for example, the administration of sucralfate, frequency of basic
observations;

() The steps to be taken to properly assess for and manage variceal bleeding, for
example, the immediate use of antibiotics;

(g) The circumstances in which a Consultant is deemed to be competent to undertake the
procedure alone or with supervision.

The Leeds team have advised me that the standardisation of practices is to be discussed at
the UK Paediatric Liver Steering Group which includes representatives from the three UK
Paediatric Liver Centres and a representative of the Paediatric Gastroenterology Centres with

an interest in hepatology.

Currently the three UK Paediatric Liver Centres have agreed to take part in an International
study which asks the Centres to recruit patients following a surveillance endoscopy to each
Centre’s normal management i.e. no prophylactic banding; prophylactic banding in certain age
groups; and prophylactic banding in most children. The centres will be required to keep a
database of the outcomes of these procedures to get a better understanding of the efficacy
and safety of prophylactic banding in children. This is not a randomised study but is deemed
to be the only way to recruit large numbers of children.

In response to part (a),(b), (c) and (d) the definitions of oesophageal variceal grading is always
subjective; hence there is a variety of grading scales in both adult and paediatric practice.
However, there will be an agreed grading scale for the International study referred to above
and this will be shared with all Centres. Photographs will be taken at endoscopy to
standardise the grading. The results of this study should help clinical teams to make
recommendations about who should be put forward for prophylactic banding; which grades of
varices should be subject to prophylactic banding; and what the risks are of inducing bleeding
by prophylactic banding.

In relation to parts (e) and (f), post-operative care is the same whether the patient undergoes
prophylactic banding or banding after bleeding, and the Leeds team will follow their current
guidelines as for management of bleeding varices.

Turning to point (g), all trainees specialising in Paediatric Hepatology are trained to band
oesophageal varices during their National Grid training. Trainees in Paediatric
Gastroenterology are trained in upper Gl endoscopy and in the recognition of oesophageal
varices. Some of these trainees will also elect to be trained in banding of oesophageal
varices. These procedures are not common outside the three Liver Centres. However, it is
often important that a Paediatric Gastroenterology service is able to band oesophageal varices
in an emergency situation. To feel confident to be able to do this, these consultants would

need to maintain their skills.

Chairman Dr Linda Pollard CBE JPDt. Chief Executive Julian Hartley

The Leeds Teaching Hospitals incorporating: Chapel Allerton Hospital, Leeds Dental Institute, Leeds Children’s Hospital,
Seacroft Hospital, St James’s University Hospital, The General Infirmary at Leeds, Wharfedale Hospital, Leeds Cancer Centre

page 4

The assessment of competency in interventional endoscopy is under discussion at a national
level within the Paediatric Gastroenterology and Hepatology College Specialty Advisor
Committee, within the Royal College of Paediatrics and Child Health.

Thank you for bringing these matters to my attention. | do hope that this response has assured
you that the Trust has given careful consideration to the matters of concern you have raised.

| note that you have shared your report with ae the British Society of Paediatric
Gastroenerology, Hepatology and Nutrition. It would be very helpful to us if, in due course, we
could be provided with a copy of their response.

If | can be of any further assistance please do not hesitate to contact me.

Kind regards.

Yours sincerely

Chief Medical Officer

Chairman Dr Linda Pollard CBE JPDL Chief Executive Julian Hartley

The Leeds Teaching Hospitals incorporating: Chapel Allerton Hospital, Leeds Dental Institute, Leeds Children’s Hospital,
Seacroft Hospital, St James’s University Hospital, The General Infirmary at Leeds, Wharfedale Hospital, Leeds Cancer Centre

Caerdydd a'r Fro
Cardiff and Vale Ysbyty Athrofaol Cymru

WALES University Health Board

Eich cyf/Your ref Heath Park, Parc Y Mynydd Bychan,

Ein cyf/Our ref Cardiff, CF14 4xw Caerdydd, CFi4 4xw

Welsh Health Telegaa TROUWULK LL <2 Phone 029 2074 7747 Ff6n 029 2074 7747
Fax 029 2074 3838 Ffacs 029 20743838

Direct Line/Uinelt uniongycho}
Minicom 029 2074 3632 Minicom 029 2074 3632

i Ov Gi G Ctra lechyd Prifysgol University Hospital of Wales
S

Tuesday, 14" April 2015

Ms Melanie J Williamson p
Assistant Coroner 17
West Yorshire (Eastern)

Coroner's Office

71 Northgate

Wakefield

WF1 3BS

Inquest fouching on the death of LLH reference MJW/IS/1801/13

Dear Ms Williamson

Thank you for your letter of the 20 February and the copy of the regulation 28 report. | sent you an initial
Opinion in my e-mail of the 3 March id we then discussed the case and some of the issues in a
telephone conversation on the afternoon of the 9" April. Since then | have had an Opportunity to discuss
my response with Dr Alastair Baker - President of the British Society of Paediatric Gastroenterology,
Hepatology & Nutrition (BSPGHAN) and he is Copied in to this formal response.

in your Regulation 28; Report to prevent future deaths under “Coroner's Concerns" (item 5) you state:

The Matters of concern are as follows:

There is no standardisation of Practises (either locally or nationally) adopted by Consuttants when
undertaking the said Procedure, by reason Predominantly of there being no national Policy and/or
guidelines in relation thereto. Such a National policy and/or guidelines shouid address the

following:

@. Precise definitions of the grades of oesophageal varices;

Which grades of varices should be subject to banding and which Should not:

Those patients who are to be deemed suitable for Placing on a banding programme

and those who are not:

d Oncea Patient is placed on a banding Programme, the assessment Process fo be
adopted prior to the said patient undergoing each Procedure:

9. Post endoscopy care, for example, the administration of sucraifate, frequency of basic

observations: cnid overleaf...

129 2074 8789 by
029 2074 8 —

Dr evan H Davies MA MRCP MRCPCH
Dr Huw R Jenkins MA MD FRCP FRCPCH 029 2074 4558
Dr Peter J Dale Visiting Consultant Paediatric Gastroenterologist (Royal Gwent Hospital)

Cc.

Dr Sarah El-Hadi Visiting Consultant Paediatrician (Princess of Wales Hospital)

Mrs Claire Sadlier Paediatric Ga stroenterology Nurse Specialist 929 2074 5331
Paediatric Gastroenterology Fax 929 2074 4559
Paediatric Gastroenterology Specialist Registrar Bleep 4958 via hospital switchboard 029 2074 7747

Page | ae

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Bwrdd lechyd Pri ! . > .
Ww Gi G Caerdydd ay Free” University Hospital of Wales

Le
CYM
QP | IS Cardiff and Vale Ysbyty Athrofaol Cymru

\ WALES | University Health Board

Eich cyf/Your ref Heath Park, Parc ¥ Mynydd Bychan,

Ein cyf/Our ref Cardiff, CFi4 4xw Caerdydd, CF14 4xw

Welsh Health Tel ecwor Phone 029 2074 7747 Ff6n 029 2074 7747
Fax 029 2074 3838 Ffacs 029 20743838

Direct Line/Linell uniongychol
Minicom 029 2074 3632 Minicom 029 2074 3632

f The steps to be taken to Properly assess for and manage variceal bleeding, for
example, the immediate use of antibiotics:
The circumstances in which a Consultant is deemed to be competent to undertake the

Procedure alone or with supervision.

Given the complexity of the question | shall answer in numbered points:

the Joint Advisory Group on GI Endoscopy (JAG) as well as a clear description of the variety of service
models that exist across the UK for the care and management of children with complex liver disease

(including portal hypertension).

(ii) | have_han hair of the BSPGHAN Endoscopy Working Group (EWG) to a Consultant
coca ila is employed as a Consultant Paediatric Gastroenterologist in the
Sheffield Oundation Trust. Clearly this makes her involvement as the new chair
impossible given an obvious com

(iii) | think (irrespective of (ii) above) that a matter of this im
BSPGHAN President rather than the Chair of the EWG. He is copied in to this response and would be

(vi TE vii almost certainly wish to discuss this with the BSPGHAN Liver Steering Group which has
representation from each of the 3 quaternary centres for the UK before responding.

{v) Alternatively and / or in addition, you may wish to direct your concerns to organizations within the UK
that have more power and influence than Our relatively small and poorly resourced society. They would
almost certainly come to BSPGHAN for advice / direction but may be better placed to take matters forward
and compel the change that you seek, Examples would be the Royal College of Paediatrics and Child
Health, JAG, the National Institute for Health and Care Excellence (NICE) or the NHS itself.

(vi) Finally, if such guidance is considered
described. It may be worth considering whether it should be part of a broader

16 years and there are currently no plans to take this forward for

QS available for patients over the age of
ns of organization and very

children. In part this is down to the relative rarity of the problem, complicatio

different service models in existence across the UK.
as
Dr ieuan B Davies MA MRCP MRCPCH 029 2074 8789
029 2074 4558

Dr Huw R Jenkins MA MD FRCP FRCPCH
Dr Peter J Dale Visiting Consultant Paediatric Gastroenterologist (Royal Gwent Hospital)

Dr Sarah E}-Hadi Visiting Consultant Paediatrician (Princess of Wales Hospital)
Mrs Claire Sadtiey Paediatric Gastroenterology Nurse Specialist 029 2074 5331
025 2074 4859

Paediatric Gastroenterology Fax
Pacdiatric Gastroenterology Specialist Registrar Bleep 4958 vin hospital switchboard 029 2074 7747

Page 2 of 3 Ms Williamson M
Re: LLH re:

Caerdydd a’r Fro

i“ as, GIG | Bwrdd lechyd Prifysgol University Hospital of Wales

G7 Nia iS Cardiff and Vale Ysbyty Athrofaol Cym ru

WALES | University Health Board

Eich cyf/Your ref Heath Park,

Ein cyf/Our ref Cardiff, CFi4 4xw

Welsh Health Telepfone Networt 72 Phone 029 2074 7747
Fax 029 2074 3838

Direct Line/Ltinell unjongycho!
Minicom 029 2074 3632

Parc Y Mynydd Bychan,
Caerdydd, CF14 4xw
Ff6n 029 2074 7747
Ffacs 029 20743838
Minicom 029 2074 3632

In conclusion, | am unable to take your concerns forward myself but hope f have offered several options

that may help advance these issues.

Yours Sincerely,

Consultant Paediatric Gastroenterologist & past Chair BSPGHAN EWG

Copied to:

President BSPGHAN)
Consultant Paediatric Hepatologist
Paediatric Liver Unit

King's College Hospital

Denmark Hill

LONDON

SE5 9RS

Dr Jevuan H Davies MA MRCP MRCPCH

Dr Huw R Jeokins MA MD FRCP FRCPCH

Dr Peter J Dale Visiting Consultant Paediatric Gastroenterologist Qoyal Gwent Hospital)
Dr Sarah El-Hadi — Visiti ing Consultant Paediatrician (Princess of Wales Hospital)

Mrs Claire Sadlier Paediatric Gastroenterology Nurse Specialist

Paediatric Gastroenterology Fax

Paediatric Gastroenterology Specialist Registrar Bleep 4958 via hospital switchboard

Page 3 of 3 Ms Williamson

be

oe

029 2074 8789
029 2074 4558

029 2074 5331
029 2074 4559
029 2074 7747