The Leeds Teaching Hospitals NHS Trust
NHS / Health Body
Action Taken
The Trust shared the coroner's report with relevant staff and clarified their existing guidelines for managing bleeding oesophageal varices, including resuscitation, antibiotic use, Sengstaken tube placement, and banding procedures. They also highlighted the training provided to paediatric gastroenterology trainees in upper GI endoscopy and oesophageal varices recognition. (AI summary)
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Dear Ms Williamson INQUEST TOUCHING THE DEATH OF LEXIE LOUISE HARRISON (Deceased) refer toeyour correspondence of 2Oth February 2015,received on 27th February, regarding fe inquest touching the death of Lexie Louise Harrison and the Regulation 28 Report to Prevent Future Deaths in respect of this case. 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 carefully and the responses t0 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 procedure"). Neither Sheffield Children's NHS Foundation Trust nor Leeds Teaching Hospitals NHS Trust has such a policy andlor guideline_ Both of the latter Trusts have undertaken the said procedure for many years: The management of bleeding oesophageal varices is 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 & 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): contld: Chairman Dr Linda Pollard CBE JP DL Chief Executive Julian Hartiey Seacroedioseichig #ospitals incorporating: Chapel Allerton Hospilal; Leeds Dental Institute; Leeds Children's Hospital; Seacroft Hospital; St James s Universilty Hospital The General Infirmary al Leeds, Wharfedale Hospieal; Leedsecancerscentre very ("the
Page 2 These guidelines are similar to those used in both London and shared the Leeds guidelines with our referring Trusts includingr Birmingham and we have Sheffield Children's Hospital. beweveurreaxie thederwent prophylactic banding of her varices Le banding before had bledel Currently there are no national guidelines for this procecure in childreg bete iswell established in adult practice and evidence has been procedure decreases the risk of spontaneous produced in adult practice that it Liver Centres in the UK undertook oesophageal bleeding: From 2006, the three Children's a study to try_toassess the benefits of prophylactic banding of oesophageal varices in children. Ifrom for this study. Of the 65 children recruited Birmingham was the chief investigator randomised into to the study only 22 had varices large enough to be the banding or non-banding arms of the study: Results were assessed after at least 6 months follow Up and 3 of the 10 children randomised whereas 1 of the 12 children randomised to no banding did bleed, banding to prophylactic banding bled a week after an elective episode_ The numbers in this study were too small to provide evidence for eficacy of prophylactic banding, although it was felt that thas the procedvre the This study is published in abstract form_ was well tolerated. Following this study, the Birmingham Team has elected to offer children with significant portal hypertension and found prophylactic banding to any endoscopy: to have large oesophageal varices at apply the same conditions as in the study which graded oesophageal varices as small occupying than a third of the radius of the oesophagus insufflation; moderate occupying between third and two thirds of the riadiugaximthe oesophagus; and large occupying greater than two thirds of the radius of the oesophagus As in the study only those with iarge oesophageal varices would be bandea. In Leeds, following considerable deliberation of the evidence available, the concluded that should only offer prophylactic clinical team who are found to have large varices banding to children over 10 years of age iiterature and therefore felt that the evidence base is much adult should await further can justify applying that to children over 10 years of age but evidence before applying this management to younger children. In King's College Hospital, London, they do not underiake prophyaclticebandingunger chdidren. There is no written protocol describing how to perform a banding procedure described in textbooks Trainees are taught this procedure although it is a certificate of completion of training in as part of their education towards Gastroenterology: Paediatric Hepatology and in Paediatric Point 2 of your report raises concerns that: (2) There is no standardisation %f practices; (either locally or nationally) , adopted bensuttants ichen underiaking the said procedurocby reasaripredomirantyobthere being no national policy andfor guideline in relation theretsc You have listed a number %f points that a national policy or guideline should address (a) Precise definitions of the grades of oesophageai varices; namely: 'b) Which grades Of varies should be subject to banding and which should Thhose Datients Who are deemed suitable for placingon & banding not; those who are not; programme and Chairman Dr Linda Pollard CBE JP DL Chief Executive Julian Hartley Seacroe diosoishing Hospitals incorporating: Chapel Allerton Hospital; Leeds Dental Seacroft: Hospilal, St James s University Hospital; General Infimary Institule; Leeds Children's Hospital, at Leeds Wharfedale Hospital, Leeds Cancer Centre very they They less during they They very they The
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 Livver Centres and 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 database of the outcomes of these procedures to 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 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 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 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 GI 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 t0 maintain their skills 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'$ University Hospital, The General Infimmary at Leeds, Wharfedale Hospital, Leeds Cancer Centre get will will
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 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 of the British Society of Paediatric Gastroenerology, Hepatology and Nutrition. It would be 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.
Page 2 These guidelines are similar to those used in both London and shared the Leeds guidelines with our referring Trusts includingr Birmingham and we have Sheffield Children's Hospital. beweveurreaxie thederwent prophylactic banding of her varices Le banding before had bledel Currently there are no national guidelines for this procecure in childreg bete iswell established in adult practice and evidence has been procedure decreases the risk of spontaneous produced in adult practice that it Liver Centres in the UK undertook oesophageal bleeding: From 2006, the three Children's a study to try_toassess the benefits of prophylactic banding of oesophageal varices in children. Ifrom for this study. Of the 65 children recruited Birmingham was the chief investigator randomised into to the study only 22 had varices large enough to be the banding or non-banding arms of the study: Results were assessed after at least 6 months follow Up and 3 of the 10 children randomised whereas 1 of the 12 children randomised to no banding did bleed, banding to prophylactic banding bled a week after an elective episode_ The numbers in this study were too small to provide evidence for eficacy of prophylactic banding, although it was felt that thas the procedvre the This study is published in abstract form_ was well tolerated. Following this study, the Birmingham Team has elected to offer children with significant portal hypertension and found prophylactic banding to any endoscopy: to have large oesophageal varices at apply the same conditions as in the study which graded oesophageal varices as small occupying than a third of the radius of the oesophagus insufflation; moderate occupying between third and two thirds of the riadiugaximthe oesophagus; and large occupying greater than two thirds of the radius of the oesophagus As in the study only those with iarge oesophageal varices would be bandea. In Leeds, following considerable deliberation of the evidence available, the concluded that should only offer prophylactic clinical team who are found to have large varices banding to children over 10 years of age iiterature and therefore felt that the evidence base is much adult should await further can justify applying that to children over 10 years of age but evidence before applying this management to younger children. In King's College Hospital, London, they do not underiake prophyaclticebandingunger chdidren. There is no written protocol describing how to perform a banding procedure described in textbooks Trainees are taught this procedure although it is a certificate of completion of training in as part of their education towards Gastroenterology: Paediatric Hepatology and in Paediatric Point 2 of your report raises concerns that: (2) There is no standardisation %f practices; (either locally or nationally) , adopted bensuttants ichen underiaking the said procedurocby reasaripredomirantyobthere being no national policy andfor guideline in relation theretsc You have listed a number %f points that a national policy or guideline should address (a) Precise definitions of the grades of oesophageai varices; namely: 'b) Which grades Of varies should be subject to banding and which should Thhose Datients Who are deemed suitable for placingon & banding not; those who are not; programme and Chairman Dr Linda Pollard CBE JP DL Chief Executive Julian Hartley Seacroe diosoishing Hospitals incorporating: Chapel Allerton Hospital; Leeds Dental Seacroft: Hospilal, St James s University Hospital; General Infimary Institule; Leeds Children's Hospital, at Leeds Wharfedale Hospital, Leeds Cancer Centre very they They less during they They very they The
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 Livver Centres and 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 database of the outcomes of these procedures to 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 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 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 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 GI 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 t0 maintain their skills 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'$ University Hospital, The General Infimmary at Leeds, Wharfedale Hospital, Leeds Cancer Centre get will will
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 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 of the British Society of Paediatric Gastroenerology, Hepatology and Nutrition. It would be 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.