February 2020 surgery
20. Mr M had TURP surgery on 11 February to try and help him with his bladder problems. An oral airway was used during the procedure and Mrs P believes this damaged Mr M’s throat.
21. Our urology adviser has explained that the stricture in Mr M’s oesophagus which was diagnosed later, was in a different part of the oesophagus to the location of the oral airway instrumentation which was used as part of the TURP surgery.
22. The records show that after the surgery in the days before he was discharged, Mr M was eating and drinking as tolerated. There were no complications recorded in the anaesthetic records.
23. We have seen no evidence to suggest the oral airway used during the TURP surgery damaged Mr M’s airway. We recognise how Mrs P has made a link between Mr M’s later problems and his surgery in February 2020, and we hope she is reassured by our investigation of this issue. This must have been a distressing and difficult time for Mr M.
May 2020 ED consultation
24. Mr M went to the ED in the evening of 13 May. Mrs P believes that more should have been done for Mr M to understand the cause of his throat problems at this time.
25. The records show that Mr M went to the ED at 6.57pm on 13 May and was seen by a GP who recorded their notes at 8.20pm. Mr M was complaining of throat discomfort which had been ongoing for three months, difficulty swallowing (dysphagia) and episodes of a hoarse voice. It was also recorded that he was able to eat and drink, had not vomited and that he denied any weight loss. It was noted that Mr M had seen his GP about these problems two weeks previously.
26. GMC Good medical practice guidance sets out the expectations for assessing a patient:
You must provide a good standard of practice and care. If you assess, diagnose or treat patients, you must:
• adequately assess the patient’s conditions, taking account of their history (including the symptoms and psychological, spiritual, social and cultural factors), their views and values; where necessary, examine the patient • promptly provide or arrange suitable advice, investigations or treatment where necessary • refer a patient to another practitioner when this serves the patient’s needs
27. The GPs examination of Mr M documented that he appeared well with no potential airway obstruction. Mr M’s respiratory rate, oxygen saturation and temperature were all within the normal range. The GP examined Mr M’s throat, neck and chest and no abnormalities were identified.
28. The assessment and examination completed by the GP in the ED was in line with the GMC guidance.
29. The assessment shows the GP found no emergency need to admit Mr M. NICE guidance NG12 outlines the symptoms and signs which should alert a doctor to the potential presence of cancer. In this guidance persistent hoarseness suggests a suspected cancer referral should be considered, and dysphagia indicates a gastrological investigation. The guidance recommends these investigations take place within two weeks.
30. The GP who saw Mr M recommended that Mr M return the following morning to see an ENT specialist for further assessment and to request further investigations. Mr M decided he wanted to follow up with his own GP instead and in the discharge summary from the ED to Mr M’s GP, it was recorded that Mr M needed a two week wait referral for suspected cancer.
31. The GP who saw Mr M on 13 May in the ED suitably identified symptoms potentially associated with cancer as set out in NICE guidance NG12.
32. GMC Good medical practice says that a doctor should ‘promptly provide or arrange suitable advice, investigations or treatment where necessary and refer a patient to another practitioner when this serves the patient’s needs’. The GP suggested Mr M return the following morning to see a specialist which is in line with this guidance. Bearing in mind the NICE guidance suggests Mr M needed further investigations within two weeks, there was no indication for more urgent action.
33. When Mr M decided he wanted to see his own GP instead, the GP in the ED clearly recorded in the discharge summary to Mr M’s GP that he needed a two week wait referral for suspected cancer. This was in line with the GMC guidance.
34. We recognise Mrs P’s concerns about the attendance at the ED as the concerns about potential cancer, must have caused her and Mr M, further distress.
35. We have seen no evidence of failings in the actions taken in the ED on 13 May.
Treatment in June/July 2020
36. Mr M’s GP made a two week wait cancer referral to the Trust on 15 May. NICE NG12 guidance says that for patients with suspected oesophageal cancer, as indicated by Mr M’s dysphagia, an endoscopy should happen within two weeks.
37. Mr M’s first endoscopy and biopsy took place on 5 June which was three weeks after the GP referral. This was not in line with the NICE guidance and indicates failings.
38. Mr M was admitted to hospital via the ED on 26 June as his swallowing difficulties had got worse. On 29 June it was recorded that the biopsy from 5 June showed no signs of cancer. A working diagnosis of GORD was made.
39. A second endoscopy took place on 1 July. On this occasion the stricture was dilated (widened). The method of dilation was not recorded, and it was noted that the endoscope was able to pass through the stricture after the procedure. A barium swallow was done on 6 July which is a test to try and identify gastroenterology problems.
40. A third endoscopy was done on 17 July. On this occasion it was recorded that a balloon was used to dilate the stricture and that after the dilation the endoscope could pass through.
41. The fourth endoscopy was done on 28 July. On this occasion it was recorded that the stricture had improved, and because of this there was no reason to perform a dilation as the endoscope could already pass through.
42. Our gastroenterology adviser has explained there are no specific guidelines for the process to be followed in trying to diagnose the cause of Mr M’s swallowing difficulties. GMC good medical practice says that a doctor should promptly provide or arrange suitable advice, investigations or treatment where necessary.
43. Endoscopies to look inside Mr M’s oesophagus and a barium swallow were all relevant investigations to try and diagnose the cause of his problems. Whilst these investigations did not resolve Mr M’s problems, they were appropriate to try and understand the cause of the issues and to try and reach a diagnosis.
44. A CT scan was also requested on 17 July. Our gastroenterology adviser has explained the CT scan was requested to try and find the cause of the stricture, looking for a possible external pressure on the oesophagus. The Trust has said the CT scan request did not include a suitable clinical rationale for the request, and it was rejected by the radiology team with the reason stated as ‘why scan a patient with a benign stricture’. There is no evidence in the records that the rejection of this CT scan was followed up or investigated further and ultimately a CT scan did not take place.
45. The Trust’s gastroenterology team felt that the CT scan was the next appropriate step to try and identify the cause of Mr M’s problems. Our gastroenterology adviser shares this view. Our gastroenterology adviser said that during the endoscopies it was possible to pass the endoscope past the stricture, but the endoscope would have been able to push the sides of the oesophagus open and indicated there was some other cause of Mr M’s eating difficulties, which was why the CT scan had been requested.
46. GMC Good medical practice guidance says that doctors should arrange suitable advice, investigations or treatment where necessary. In this instance the CT request did not suitably set out the reasons for the CT scan and when the request was rejected there was no follow up to understand why, and to rearrange as required. Suitable investigations were not arranged as set out in the GMC guidance, indicating failings. Not having a relevant test during such a challenging time, would have added to Mrs P’s concerns about Mr M’s treatment and we understand why she is concerned about this issue.
47. Mrs P is also unhappy about the timing of the endoscopies. Whilst there is no specific guidance which states when endoscopies and dilations should happen, BSG guidance suggests weekly or two weekly dilations and GMC Good medical practice guidance says investigations should be completed promptly.
48. Mr M had three endoscopies in a four-week period while he was an inpatient. During two of these procedures the stricture was dilated. Our gastroenterology adviser has explained that after such procedures, there is a period of assessment to see how successful they have been.
49. We are satisfied that having three endoscopies within four weeks whilst Mr M was an inpatient, was in line with the two pieces of relevant guidance.
50. Mrs P has also raised concerns about how the dilation was completed as part of Mr M’s endoscopies. She believes the wrong type of dilation was done.
51. The first dilation was done on 1 July and on this occasion the dilation method was not recorded. The dilation on 17 July was recorded as having been completed using a balloon.
52. The Trust’s response says that the wrong dilation method was used on 1 and 17 July as the endoscope itself was used, rather than a balloon. The Trust’s response also references a discussion that was had with Mr M on 21 July, explaining there were concerns about whether the dilation took place or not and offering apologies.
53. Dilation was not required at the repeat endoscopy on 28 July as the scope could already pass through the stricture, suggesting the previous dilations had been successful.
54. BSG quality standards guidance on gastrointestinal endoscopies sets out the standards to be met when completing endoscopies. These include issues related to consent, safety checklists, sedation, photo-documentation, the use of biopsies and the recording of findings.
55. BSG guidance on oesophageal dilation explains relevant guidelines for dilation procedures and includes issues around where to complete dilation, the equipment to be used, how wide the dilation should be, recovery and aftercare.
56. We cannot with any certainty say how the dilation was performed at the 1 July endoscopy as this was not recorded. Our gastroenterology adviser has commented that it was most likely to have been a balloon, as this was the most common technique and the one which was used on 17 July. However, the Trust’s response says that it appears the endoscope itself was used instead of a balloon. We cannot say what procedure was used.
57. At both dilations the stricture was widened enough for the scope to pass through, and the amount of widening was in line with the BSG guidance.
58. Having reviewed the documentation for Mr M’s endoscopies, we are satisfied these investigations were conducted in line with the BSG guidance. There is some uncertainty about how the 1 July dilation was done, but we are not persuaded the actions of the Trust amount to failings.
59. Mrs P is also unhappy that Mr M was told a stenting procedure had been done on 17 July, and that because of this he would be able to go home. Mrs P says that Mr M was then told the stent had not actually been done.
60. There is reference to stenting being one of the possible treatments for Mr M in his notes and on 17 July the endoscopy procedure included a dilation to widen the stricture. It is also documented that the plan was for Mr M to return home after the 17 July endoscopy and dilation.
61. On 18 July it is recorded that Mr M said he did not feel able to return home because he felt his throat was swollen. Mr M was reviewed over the following days, and he remained in hospital for further assessment.
62. We have not seen any evidence to suggest the use of a stent was specifically planned and then the decision changed, or the procedure altered. The plan was for Mr M to return home, and it must have been frustrating for him when this was not possible as soon as he thought. It must have been upsetting for Mr M if he thought the stenting procedure was going ahead. We are not persuaded there is any evidence of failings in this aspect of the complaint.
Impact
63. We have identified failings in the time taken to deal with Mr M’s referral from May 2020. The guidance says the endoscopy should happen within two weeks of the referral, but it took three.
64. The biopsies from the endoscopy on 5 June showed no signs of cancer and Mr M was therefore removed from the cancer pathway. The failing identified here had no impact on Mr M. No onward referral was required because there was no cancer and therefore this one-week delay did not have any impact on his treatment or diagnosis.
65. The other failing we have identified is in relation to the failure to conduct a CT scan. A CT scan was requested on 17 July, but this request was refused and not followed up. This meant Mr M did not have a CT scan. The biopsies of the stricture had been negative for cancer, so there was a different cause of the stricture. The CT scan was proposed to try and find this cause.
66. Our gastroenterology adviser has explained that the endoscopic findings of narrowing of the oesophagus were attributed to the presence of oesophagitis (inflammation of the oesophagus). However, the endoscopic changes of oesophagitis were out of keeping with the degree of narrowing seen at endoscopy and the severity of Mr M symptoms. Our gastroenterology adviser went on to say, it is more likely that the narrowing seen at endoscopy was caused by external compression of the oesophagus due to the lung cancer.
67. Our gastroenterology adviser has also explained that the scan Mr M had on 11 November at a different hospital, showed enlarged lymph nodes. The position of these lymph nodes corresponds with the narrowing of Mr M’s oesophagus that was seen on his endoscopies.
68. We cannot say with any certainty what the CT scan would have revealed if it had taken place after the 17 July request. We therefore take a balance of probabilities view, which is where we consider what is more likely than not to have happened. Taking into account the evidence we have seen from the subsequent scan, Mr M’s ongoing dysphagia and the comments of our gastroenterology adviser, on the balance of probabilities, we believe an earlier CT scan would have identified his lung cancer.
69. Mr M’s cancer was ultimately diagnosed from scans in October. Had the CT scan taken place as requested it is possible his cancer could have been diagnosed around three months earlier.
70. We have taken specialist oncology advice to understand what the CT scan may have revealed and what impact this would have had on Mr M’s potential treatment. It is impossible to know how advanced Mr M’s cancer was in July 2020 and we cannot know if it was metastatic (had spread to other parts of the body).
71. If the cancer had been identified the relevant treatment would have been dabrafenib and trametinib (dab-tram) as set out in NICE Guidance TA898. This guidance was published after Mr M’s treatment but was the relevant treatment at the time, so is relevant here.
72. This treatment requires tablets to be swallowed as the medication is not available in any other form. Mr M continued to have ongoing swallowing difficulties, and we cannot say whether he would have been able to tolerate this treatment or not.
73. After Mr M’s cancer was diagnosed, dab-tram was recommended as the relevant treatment. In December 2020 it was initially agreed that Mr M was not strong enough to withstand the treatment and that his cancer was not curable. In January 2021 Mr M returned for a further review when he signed a consent form to start the dab-tram treatment as it was felt he was well enough.
74. In February, Mr M said he wanted to wait until his weight had improved and that he was concerned about the potential side effects of the dab-tram. It was recorded that Mr M was clear that he did not want to start the dab-tram treatment, despite being well enough to do so. In March further contact was made with Mr M when he said he wanted to defer treatment for a few weeks.
75. We cannot say if Mr M would have been more willing or able to start treatment if an earlier diagnosis had been made from the CT scan requested in July 2020.
76. If Mr M had been able to swallow the tablets and was willing to go ahead with the treatment , the NICE guidance TA898 says this treatment has a median progression-free survival of 11 months (which means that in clinical trials 50% of patients starting the treatment had their cancer still under control at 11 months) and a median overall survival of 17 months (which means that in clinical trials 50% of patients starting the treatment were alive at 17 months). This also means that 50% of patients would not have been alive/had their cancer controlled at those points. It is not possible for us to say which group Mr M would have fallen into.
77. Mrs P is understandably concerned that if an earlier cancer diagnosis had been made, Mr M may have been able to have earlier treatment that could have made a difference.
78. As explained above, on the balance of probabilities, we consider the CT scan would have identified Mr M’s lung cancer. However, there are too many unknowns for us to be able to reach a conclusion and what treatment it may have led to for Mr M, whether he would have been able to tolerate this treatment and whether he would have been willing to start the treatment.
79. Not completing the CT scan led to a loss of opportunity to provide treatment to Mr M, but we are unable to say what impact this treatment would have had. Mrs P believes the actions of the Trust led to the death of Mr M. We are not able to reach this conclusion, but we recognise that Mrs P is now left with never knowing whether things could have been different. This must be extremely difficult for Mrs P and her family. We make recommendations below to address this injustice.