East Lancashire Hospitals NHS Trust

6. Mrs O complains that between August 2021 and April 2022, the Trust:

• did not complete appropriate checks for cancer for Mr L • failed to provide the appropriate treatment which could have saved her father’s life.

• did not complete appropriate checks before discharging her father.

7. Mr L died in early April 2022. Mrs O believes the way the Trust handled her father’s care negatively affected his health, and ultimately killed him.

8. Mrs O wants the Trust to acknowledge the failings and apologise. She also wants it to put in place significant service improvements.

9. Mr L was in his mid-seventies at the time of the below events. He had a clinical history of anaemia, hiatus hernia, and achalasia. Achalasia is a rare disorder of the food pipe (oesophagus), which can make it hard to swallow food or drink.

10. On 8 September 2021, Mr L attended the Emergency Department at a different trust after experiencing dizziness and jaundice in August. He experienced a gastrointestinal (GI) bleed during his admission which staff felt was due to an ulcer.

11. The records show clinicians were also investigating whether his jaundice was caused by gastrointestinal cancer. A multi-disciplinary team (MDT) including clinicians from the Trust reviewed his case on 15 September, and planned for an ERCP (a combined endoscopy and X-ray) and brushings (a method of taking cell samples in areas that are prone to bleeding.)

12. The ERCP had to be abandoned because Mr L experienced a GI bleed. The same thing happened when the ERCP was attempted again on 27 September.

13. Mr L was then transferred to the Trust. The transfer summary notes that he had abnormal liver function tests and that CT scans showed swelling and obstruction of his bile duct.

14. The Trust attempted a further ERCP. This was abandoned due to changes in the shape of Mr L’s small intestine. The ERCP report states Mr L would need a percutaneous transhepatic cholangiogram (PTC, this involves X-rays to try to find blockages in the bile duct and/or to place stents or other drainage.)

15. On 7 October, Mr L had the PTC to insert a stent for drainage. An MDT met on 15 October but decided to delay discussion until the PTC report came back. Mr L’s blood results came back on 16 October. The records show his liver function had improved, and the Trust discharged him that day. The discharge summary notes that he was stable and would need a follow-up appointment.

16. The MDT met again on 22 October. Notes from the meeting show they were still waiting for the PTC results but there was a plan to review him as an outpatient.

17. On 5 November, Mr L had an outpatient appointment at the Trust with a hepato-pancreato-biliary surgeon, Mr R (HPB is a specialism in the treatment of liver, pancreas, bile duct and gall blader disorders). The clinic letter from this appointment shows he was still slightly jaundiced and had lost some weight (but his appetite had started to improve).

18. Mr R explained Mr L’s scans suggest a mid-bile duct stricture (blockage), but do not clearly show the state of the surrounding tissue. They advised they would discuss his case at the next MDT meeting and be back in touch to explain the best course of action.

19. The MDT notes from 12 November state Mr L had a diagnosis of mid bile duct stricture with ‘probable malignancy’. The MDT advised up to date scans and further review in clinic. They noted that the malignancy was ‘technically resectable [removable] based on [the] last scan’.

20. The same day, Mr L experienced another GI bleed. He was admitted again to the first trust and given a blood transfusion and scans. In a further MDT on 19 November, clinicians noted his most recent scans showed no change in terms of the bile duct blockage. They recorded a plan for Mr L to see Mr R in clinic to discuss ‘Whipple procedure’ (major and complex surgery to treat pancreatic or bile duct cancer).

21. Mr L’s GP practice emailed the first trust on 2 December as they felt ‘his follow-up plan all seems a little vague and he is continually declining’. They also wrote to Mr R and noted that Mr L had had two very significant upper GI bleeds this year, and that there didn’t seem to be any explanation or management plan.

22. In the meantime, Mr L had another appointment with Mr R on 6 December. The clinic letter from this appointment states the most recent scan showed a lesion, but this was not likely to be malignancy as it had not grown. Mr R explained they were ‘unable to get tissue diagnosis, given his achalasia’ so cancer could not be ruled out.

23. Mr R explained that as Mr L is ‘losing weight and has possible features of pancreatitis [inflammation of the pancreas], it could be that he has got pancreatic insufficiency related to previous pancreatitis and that is the cause of his stricture.’ He explained he was not currently fit for surgery and that this may not be in his best interests without a confirmed diagnosis. Mr R arranged for further blood tests (including tumour markers) and a further CT scan in two-to-three-months.

24. On 10 December, Mr L’s case was discussed at a Trust interventional radiology meeting. They recorded a plan for a further PTC, as well as internal and external brushings.

25. On 6 January 2022, Mr R wrote to Mr L’s GP in response to their letter of 9 December. They explained that his GI bleeds may be related to his achalasia. They explained they had requested a further PTC for insertion of a metal stent for ‘a more permanent solution to his stricture’.

26. This took place at the Trust on 18 January, along with brushings. The discharge summary notes that the procedure was done because there was an indication of ‘cholangiocarcinoma’ (bile duct cancer). Mr L’s GP wrote to Mr R to query this as they thought cancer had been excluded, and Mr R explained this was recorded in error.

27. Mr L’s daughter emailed the Trust on 31 January to explain her father was still waiting for scans and a diagnosis. Mr R reviewed him over the phone the same day. They recorded that his diagnosis was a biliary stricture, likely related to pancreatitis. They also noted this was more likely than pancreatic cancer and his tumour markers remained normal. They explained this was ‘reassuring’, but they were organising a further CT scan to reassess him.

28. On 15 February, Mr L’s daughter emailed the Trust to raise more concerns about her father’s treatment. She explained there is still no diagnosis and that, during his most recent admission, had been discharged back to his GP despite having abnormal blood results. She explained this resulted in a further admission to hospital.

29. A further MDT took place at the Trust on 18 February. This noted that his recent scans showed the soft tissue mass surrounding Mr L’s stent looked to have grown. They planned for Mr R to review him in clinic and check his bloods for markers of pancreatic cancer.

30. On 28 February, Mr L saw Mr R in his clinic. Mr R explained that his recent brushings showed likely cancer in the head of the pancreas. He explained this was technically operable, but Mr L was not fit for surgery and does not want an operation. He explained he would like to consider chemotherapy.

31. On 4 March, the Trust held a further MDT meeting. The notes show clinicians planned for Mr L to have a metal stent inserted. They noted that he did not want to consider surgery and should be referred for palliative chemotherapy.

32. On 22 March, Mr L had the stent inserted and was discharged home to await an oncology appointment. At the appointment Mr L was advised he was unfit for palliative chemotherapy.

33. Mr L sadly died from his cancer on 8 April.

Diagnosis and treatment

38. Mrs O complains that the Trust delayed in diagnosing and treating her father’s cancer. She explained Trust clinicians were almost certain he had cancer in November 2021, but clinicians did not formally diagnose or treat him for this before he died in April 2022.

39. Mrs O also complains the Trust inappropriately discharged Mr L in January 2022 despite him being very unwell and not fit for discharge.

40. In responding to the complaint, the Trust explained Mr L’s achalasia made treatment with an ERCP impossible. It explained this made diagnosis difficult and his tumour markers were not significantly raised.

41. The Trust explained that Mr L was not fit for surgery but acknowledged there was a delay in receiving his cytology results (examination of cells to check for cancer) due to poor staff availability and the COVID-19 pandemic. It did not specifically comment on the discharge in January.

42. When we investigate a complaint, we first consider what should have happened by looking at what the relevant clinical guidance says. We then look at what did happen and consider whether this fell short of the relevant guidance.

43. NHSE guidance on cancer waiting times at the time of Mr L’s admission state that 75% of patients should receive a diagnosis or ruling out of cancer within 28 days of referral.

44. NICE guidance (section 1.2) explains that acute pancreatitis usually presents with sudden-onset abdominal pain. It explains nausea and vomiting are often present, and the condition can be confirmed with laboratory tests and imaging.

45. BSG guidance on pancreatitis also explains the condition can be diagnosed based on a clinical history of pain, significantly elevated serum amylase (an enzyme produced by the pancreas) levels, and a CT scan showing pancreatic inflammation.

46. ESMO guidelines set out the recommended steps to diagnosis of biliary tract cancer. Our adviser confirmed these guidelines had not been published at the time of Mr L’s admission, but summarise the steps clinicians would be expected to take at the time to investigate/diagnose the condition, including:

• blood tests to assess liver function • ERCP or PTC to assess and treat biliary obstruction, and to obtain tissue for diagnosis • imaging (such as ultrasound, MRI, or CT scans) to detect and stage tumours.

47. ESMO guidelines also explain surgery is the only treatment that can cure biliary tract cancer.

48. Mr L was first admitted to hospital at a different trust in September 2021 with dizziness and jaundice. The records do not show he had experienced sudden-onset abdominal pain or vomiting. Staff at the time recorded that they were investigating whether cancer was the cause of his jaundice. A planned ERCP (with brushings) was abandoned twice due to GI bleeds.

49. He was transferred to the Trust in late-September. The Trust noted that he had abnormal liver function results and CT scans showing blockages and bile duct obstruction. Staff attempted a further ERCP which again had to be abandoned. Because of this the Trust planned for a PTC to try and identify the blockages in his bile duct.

50. Our adviser gave their view that the Trust was following the correct diagnostic steps at this point. They explained that Mr L’s presentation and scans were highly suggestive of cancer, and the clinicians acted in line with ESMO guidelines in arranging for a PTC when an ERCP could not take place. The records show the Trust had access to liver function tests and CT scans, also in line with ESMO guidelines.

51. However, our adviser highlighted that the Trust delayed in arranging and properly carrying out some of these investigations.

52. As clinicians first suspected cancer on 8 September, Mr L should have ideally received a diagnosis (or ruling out) of cancer by 6 October (within 28 days, as per NHSE guidance).

53. Due to low staff availability, we can see the planned PTC did not take place until 7 October. When it was performed, it was used only to place a stent for drainage. There was then no attempt by clinicians to obtain any biopsies or brushings until the repeat PTC on 18 January 2022.

54. Our adviser gave their view that clinicians should have attempted to take brushings much sooner than this. They explained that internalisation of the drainage (where the stent restores natural flow) normally takes place within a week or two, and that there was therefore an opportunity to obtain brushings once this had happened (by November at the latest).

55. Our adviser acknowledged that Mr L’s case was complex due to his pre-existing conditions (making adherence to NHSE timescales difficult) but they felt this delay was excessive, and represented a missed opportunity for an earlier diagnosis.

56. Considering the available evidence and advice received, our current view is that the Trust failed to act fully act in line with ESMO guidelines. Although clinicians arranged the correct tests to investigate potential bile duct cancer, there was a significant delay in carrying them out (which meant it was unable to meet NHSE timescales for diagnosis).

57. Once the brushings were finally taken, the Trust also acknowledged a delay in processing the results. It appears this was due to staffing levels and linked to the demands caused by the COVID-19 pandemic. The Trust explained that results would normally be available within one-to-two weeks of brushings, but this took just over a month in this case.

58. We recognise that this was partly due to factors outside of the Trust’s control, and this was a period of exceptional demand across the NHS. As such, our current view is that this two-week delay does not represent a failing in and of itself. As detailed above, we feel the Trust did miss an opportunity to take samples in October which would have mitigated the impact of further delays.

59. Mr L had his first outpatient clinic appointment with the Trust’s consultant, Mr R, on 5 November. There were also a number of MDT meetings to discuss his case and plans for him to discuss a ‘Whipple procedure’ with Mr R.

60. At a further appointment on 6 December, Mr R explained that Mr L may not have cancer and may have features of pancreatitis. They noted that he was not fit for surgery, and in any case, this would not be appropriate without a confirmed cancer diagnosis.

61. Our adviser gave their view that there was nothing in Mr L’s presentation or clinical notes to suggest a diagnosis of pancreatitis. They explained he did not have the features listed in NICE and BSG guidelines, having presented with no pain, and having no scans suggesting pancreatic inflammation. We can also see from the clinical notes that there was no record of elevated serum amylase levels.

62. Our adviser explained Mr L’s presentation in November was highly suggestive of cancer. They acknowledged more tests were needed to confirm this but explained it was very unlikely he had pancreatitis.

63. As above, we consider the Trust delayed in carrying out these tests which likely led to a delay in detecting his cancer. We asked our adviser whether the Trust might have been able to treat Mr L had it taken brushings earlier or diagnosed him earlier.

64. Our adviser explained there was no missed opportunity for the Trust to provide treatment for Mr L’s cancer. They explained that major surgery is the only potentially curative treatment for bile duct cancer. This is confirmed by the information in ESMO guidelines.

65. We can see from the records that Mr L did not want surgery, and clinicians determined he was not fit for it. Our adviser confirmed surgery would not have been suitable at any point due to a combination of jaundice, frailty, and Mr L’s own wishes.

66. They explained the only option would therefore have been palliative care and symptom control. They explained he also would have been unfit for palliative chemotherapy and that this might have negatively impacted his quality of life, even if he had been strong enough to consider it.

67. Considering the available evidence and advice received, we do not feel the Trust failed to provide treatment that might have saved Mr L’s life. Unfortunately, surgery was the only option that might have done so, and he was both unable and unwilling to have this.

68. We also considered the Trust’s decision to discharge Mr L in January 2022. The discharge summary from this admission shows he had received a blood transfusion after the PTC, but there were no other post-operative concerns, and he has fit for discharge.

69. We asked our adviser whether the Trust should have kept Mr L in hospital for longer after the January PTC. They explained that although his CRP (a protein made by the liver which signals inflammation) was raised, his other blood results were stable, his white cell count was normal, and there was no clear indication of sepsis. They gave their view that the discharge was safe and appropriate, and that there was an appropriate follow-up plan in place.

70. Having considered this advice, along with Mr L’s medical records, we cannot see evidence to suggest he was unfit for discharge in January. We recognise that him being readmitted to hospital shortly afterwards will have been distressing for both him and Mrs O.

71. In summary, our current view is that the Trust did not fail to provide Mr L with appropriate treatment. However, we have found that it delayed in completing the necessary investigations for his symptoms and presentation.

72. We have gone on to consider in more detail what impact this had on him, and on Mrs O.

Impact

73. Mrs O feels the delay in diagnosis negatively affected her father’s prognosis and ultimately caused his death.

74. As detailed above, there was sadly no treatment Mr L could have had to save his life. Surgical removal (resection) is the only option to treat biliary duct cancer; he was not fit for surgery and did not wish to go through with it.

75. Our adviser explained that most patients with unresected bile duct cancer die within a year. It therefore appears that there was sadly nothing the Trust could have done to prevent his death. Although this will not lessen the impact of his death, we hope this provides some degree of reassurance to his family.

76. Although we do not feel Mr L’s death was avoidable, we consider that the delays in diagnosis had a significant emotional impact on both him and his daughter. This is especially true considering the seriousness of his prognosis and the short amount of time he had left.

77. The Trust’s complaint file shows both Mr L’s GP and daughter raised concerns about the lack of clear diagnosis and plan for treatment. For example, on 15 February, Mrs O wrote to the Trust to explain that Mr L was ‘living with a great deal of uncertainty regarding his health which is having a psychological impact on him’.

78. We recognise that it would have been incredibly difficult for him to not know the cause of his illness. We also recognise the impact of this on Mrs O. It would have been significantly distressing to witness a close family member being so unwell and to not know the cause of this, or what treatment might be available.

79. Had the Trust diagnosed Mr L sooner, both he and his daughter would have had access to vital information about his condition. They also would have had more time to process his diagnosis and prognosis, and to plan for his final months.

80. Instead, Mrs O’ correspondence shows that they felt they were left in the dark. In her email to the Trust after Mr L died, Mrs O explained he spent the last eight months of his life ‘being fobbed off’ and being ‘given conflicting information which impacted greatly on his psychological wellbeing’.

81. This is a significant and avoidable emotional injustice, and hade recommendations for the Trust to put this right.

1. We would like to pass our sincere condolences to the Mrs O family for the death of her father, Mr L. We appreciate this was an extremely difficult time for them and recognise the events complained about continue to cause them significant distress.

2. We partly uphold Mrs O’s complaint about the Trust.

3. We have found the Trust caused avoidable delays in the diagnosis and treatment of Mr L’s cancer.

4. We do not deem these delays impacted on Mr L’s treatment or prognosis. We found there was sadly no opportunity for treatment to save his life.

5. We consider the failings we have found will have had a significant emotional impact on Mr L and Mrs O, worsening their distress at an already very difficult time. We go on to make recommendations to address this.

82. Mrs O as told us she wants the Trust to acknowledge the failings and apologise. She also wants them to put in place significant service improvements.

83. We make recommendations in line with our Principles for Remedy which say public bodies should acknowledge failures, apologise, make amends, and use the opportunity to improve their services.

84. Our Principles for Remedy are reflected in the NHS Complaints Standards which say organisations should offer fair remedies to put things right and identify learning and use it to improve services.

What we found

85. As we have found within our report, whilst failings in delays in the diagnosis and treatment, which we do not consider this impacted on Mr L’s treatment or prognosis. However, we have not seen the Trust have acknowledged the full extent of the impact as described above. As a result, we have partly upheld this complaint.

What the organisation should do

86. Our Principles for Remedy say organisations should acknowledge poor service and take steps to put things right when this leads to an injustice or hardship.

87. We recommend the Trust acknowledges the failings and provides an apology to Mrs O.

• acknowledge and apologise for the failings • send a copy of this letter to us by 10 03 26.