Stephen Whitehead

Executive Summary
Response to Coroners Regulation 28 Report Request: Stephen Whitehead RIP.
The BSG notes HM Coroner’s request under Regulation 28 and is pleased to file the attached
response on behalf of the Society.
Expert opinion is provided by the Endoscopy Section of the BSG, taking views from individual
national experts. In response to your questions we note: ‐
1) Biliary stenting is common and there are consensus guidelines on good practice
produced by the BSG, NICE and other bodies.
2) Levels of expertise and local practices vary within guidance (dictated by local expertise
and systems and services)
3) This case highlights the need for basic adherence to the principle of definitive bile duct
stone clearance which should be the goal in all patients: long‐term stenting is not
appropriate except in circumstances of extreme comorbidity.
4) There will be variation in the approaches to bile duct clearance and timing of surgery
between Units (expertise dependent) but this should not preclude
a) clear communication between medical and surgical teams (if necessary through a
formal MDT process)
b) clear communication with the patient and patient’s family of the management plan
c) clear recording of the next step of the technical pathway by the ERCPist performing
the stent insertion (backed up by a robust record of stent placement and the interval
and need for patient recall)
5) In the views of the Society a National Stent Registry would not contribute to the above.
Separately we should point out that reduction in variation in practice is one of the objectives
of the Get It Right First Time (GiRFT) initiative. The first National Gastroenterology Lead for
this is now in post and will be working closely with the BSG on matters of best practice and
reduction in practice variation.
Dr Cathryn Edwards MA D.Phil FRCP
BSG President
Re: Stephen Whitehead DOB 18/04/1960 died 08/02/2018 at The Royal Oldham Hospital
Whilst the devastating outcome for Mr Whitehead is unusual we recognise that the bile duct
stone disease is the most common indication for the more than 50,000 ERCPs performed in
the UK each year, of which a significant proportion will result in the insertion of a biliary stent.
The use and monitoring of biliary stents is therefore an important issue for patients and
endoscopy service provision. Following consultation with colleagues within the BSG
important we feel that there are a number of issues raised, for which we also have proposals:
1. Communication. It is not clear from the details provided whether clear and explicit
written information was provided to the patient, GP, and surgical team that a stent had
been inserted, the necessity of subsequent removal, and the timeframe for this to
happen. In writing to endoscopy units/BSG members we will emphasise the importance
of this measure, and the need for a clear directive on every ERCP report which (as is
standard) is given to each patient and their doctor.
2. Ownership of management. A well recognised issue within ERCP practice is a perception
(and perhaps reality) that the ERCPist is doing the procedure ‘for the surgeons’, with
overall management (beyond the ERCP itself and immediate post‐procedure period)
remaining the responsibility of others. This is understandable, given that on‐going
decisions concerning timing of cholecystectomy or other biliary surgery will directly
impact on timing of (or need for) further ERCP. The summary of the case alludes to this
issue, and may certainly have been an issue in the patient being lost to follow up. We
propose that a plan for repeat procedure (e.g. at 3‐4 months) should be set at the time of
ERCP. Whilst this may need to be cancelled/amended, according to the unpredictable
nature of changing patient circumstances (e.g. intervention, comorbidity), it may act as
an important ‘safety net’
3. Database of stents. We completely agree that a clear record of when a stent has been
placed, and when this should be removed or changed, is important. We feel this should
be within the ownership of the endoscopy unit that has inserted the stent. This may be a
formal database or a facility within the electronic endoscopy reporting tool, but should
be contemporaneously entered at the time of the ERCP, with a clear plan as to timeframe
for patient review/repeat procedure. Crucially the system should allow easy, rapid and
demonstrable review of all patients who have undergone stenting within an extended
time period.
After careful consideration, we do not feel that the answer is a national database of biliary
stents. This would be unwieldy and require significant additional manpower and
infrastructure to police. The vast majority of patients will have their care in one locality
and, as suggested in the report, shortcomings in local arrangements of care, including
communication between local teams, GP and patient, were the fundamental issues
highlighted here. Although the National Endoscopy Database (NED) has now been
introduced nationally, it is important to record that this does not allow individual patient
tracking, and could not act as a proxy database of biliary stents. The BSG and JAG are
however in discussion concerning adding the use of a stent planning/recall database to
the key performance indicators (KPI) within its national standards framework, and
incorporating it into the ISREE (Improving Safety and reducing Errors in
Endoscopy) programme. This topic will be formally discussed at the BSG Endoscopy
Committee in October.
4. Overall management of complex biliary stone disease. Although not specifically
addressed in the coroner’s report we would raise a concern that the patient’s disastrous
outcome with respect to cholangitis/retained stent and ‘lost to follow up’ relates in part
to the overall management of complex stone disease. It appears that the patient
underwent a lap chole with a 'large gallstone' still within the bile duct, which would be an
unusual approach. It is not clear from the report that there was an overall plan of
management to address removal of the bile duct stone. Recent BSG and NICE guidelines
on gallstones make it clear that definitive bile duct stone clearance should be the goal in
all patients, and that long‐term stenting is not appropriate except in circumstances of
extreme comorbidity. This is supported by published data. With the increasing availability
of advanced techniques to achieve stone clearance, and all hospitals now sitting within
HPB networks, all patients with complex stone disease should be referred to a centre
experienced in management, if not available locally.
We would be extremely happy to discuss these issues further, but hope that they address
many of the concerns raised by the coroner.
Yours sincerely,
Dr George Webster
VP (Endoscopy) British Society of Gastroenterology

ae Caroline Dinenage

Depa rtment Minister of State for Care
of Health & 39 Victoria Street London
Social Care SWIH OEY

020 7210 4850
Our reference: PFD 1138998
Ms L Hashmi
HM Area Coroner, Manchester North
Coroner's Service
Phoenix Centre
L/Cpl Stephen Shaw MC Way
Heywood
OL10 1LL

th
5 “september 2018

Dor T1s Hasun' ;

Thank you for your letter of 28 June to the Department of Health and Social
Care about the death of Mr Stephen Whitehead. I am responding as Minister
with portfolio responsibility for hospital care quality and patient safety.

I was extremely saddened to read of the circumstances surrounding Mr
Whitehead’s death. If you have the opportunity, please convey my sympathies
to his family. I can appreciate this must be a difficult time for them.

Your report was issued to the British Society of Gastroenterology (BSG) and I
understand the Society has provided a response. You will therefore be aware
that after careful consideration, the Society is of the opinion that a national stent
registry is not required, instead pointing to the existing guidance available and
the need for clear communication between medical professionals and with the
patient, as well as the clear recording of next steps in management plans.

This view is supported by the National Institute for Health and Clinical
Excellence (NICE) which points out that in this case there appeared to be an
intention to remove the stent but this did not happen due to an administrative

error. It is not clear how the establishment of a national stent registry would
have avoided the sad outcome in this case where there were apparent
shortcomings in the local arrangements for care.

I am informed that the Pennine Acute Hospitals NHS Trust has since
established an ERCP (endoscopic retrograde cholangiopancreatography) biliary
stent oversight meeting which has overseen an in-depth review of the current
system of following up patients after having an ERCP and stent insertion.
Amongst other actions, this learning is being shared across the Northern Care
Alliance (the Salford and Pennine NHS trusts) to support a review of the
management and follow up of all implantables.

This is encouraging to see and you will know that the BSG and its Joint
Advisory Group are in discussion conceming the addition of a stent planning or
recall database to the key performance indicators within the national standards
framework, and incorporating it within the Jmproving Safety and reducing
Errors in Endoscopy programme.

In addition, the BSG is proposing that a plan for a repeat ERCP (in for example,
three to four months’ time) is set at the time of the ERCP. While this
appointment might need to be re-scheduled in light of circumstances, it may act
as an important ‘safety net’.

On your second matter of concern relating to the definition of ‘short term’ in
clinical guidance, my officials have sought the views of NICE.

As you may be aware, NICE issued clinical guideline 188 on ‘Gallstone
Disease: Diagnosis and Management’! in October 2014. This includes the
following advice: ‘If the bile duct cannot be cleared with ERCP, use biliary
stenting to achieve biliary drainage only as a temporary measure until
definitive endoscopic or surgical clearance’.

NICE advises that the definition of ‘short term’ is understood in the field and
appears to be been understood by the team caring for Mr Whitehead, as they
had planned to remove the stent after a few weeks. NICE therefore considers
that the recommendations in NICE guideline 188 remain appropriate.

In conclusion, I am satisfied that there is consensus that a national stent registry
is not required and that best practice guidance is available. I am also assured
that the BSG has carefully considered the matters raised in your report and will
take forward action where it considers it appropriate.

1

s://www.nice.org.uk/guidance/cg188

Importantly, you will know from the BSG’s response that there is a national
initiative, Getting it Right, First Time’, that aims to improve the quality of care
through the reduction of unwarranted variations in practice. There is a
gastroenterology workstream led by a clinical lead and the focus will be on
disseminating best practice and reduce variations in clinical quality, efficiency
and productivity. For completeness, NHS Improvement has brought the
concerns in your report to the attention of the GIRFT clinical lead for
gastroenterology, Dr Beverly Oates.

Thank you for bringing your concerns to our attention.

? hitp://gettingitrightfirsttime.co.uk/