14. Guidance in place at the time of Mrs B’s referral, NICE NG12, says patients with suspected endometrial cancer should receive an ultrasound scan, with a view to ruling cancer in or out within 28 days.
15. On 9 December Mrs B’s GP referred her to the Trust. On 15 December the Trust completed an ultrasound scan, which showed a very significant thickening of the lining in the womb, measuring 34mm. This is suggestive of endometrial cancer.
16. The Trust decided to complete a pipelle biopsy (completed on 23 December). It said this was in line with BGCS guidelines.
17. BGCS guidelines say if ultrasound scan shows ‘endometrial thickness measurement of [more than or equal to] 4mm, an outpatient endometrial biopsy should be carried out’.
18. We asked our gynaecology adviser if a pipelle biopsy was an appropriate follow up test to the ultrasound scan in Mrs B’s case. Our gynaecology adviser explained this type of biopsy has over 90% success rate in detecting endometrial cancer and there was no indication it was not suitable here.
19. We have also seen this diagnostic test is supported by studies in this area such as the pipelle biopsy research study.
20. Considering the likely high success rate of a pipelle biopsy, it had a high chance of providing a diagnosis. We consider it was an appropriate test to use.
21. Unfortunately, the test results were inconclusive. The sample size was adequate and taken from the correct place, but the sample of cells did not allow the pathologist (the clinician who looks at the cell samples) to reach a finding. In hindsight we know this was because of Mrs B’s cancer, but this was not clear at the time.
22. There was no specific guidance in place at the time that stated a clear pathway when a test was inconclusive.
23. The NHS introduced national guidance in March 2023 as part of its faster diagnostic pathways work. This is called ‘Implementing a timed gynaecology cancer diagnostic pathway’.
24. This guidance identifies a clear pathway for diagnosing patients with endometrial cancer. It recommends an MRI scan by day 18 of referral if there is significant clinical suspicion and a diagnosis has not been made.
25. Whilst this pathway was being trialled in some Trusts at the time of Mrs B’s referral a few months earlier, it was not yet in place at Wirral University Teaching Hospital NHS Foundation Trust.
26. The Trust decided to retake the biopsy. We asked our gynaecology adviser if in their experience, this was a reasonable next step. They confirmed it was.
27. GMC guidance says in providing clinical care doctors should ‘promptly provide (or arrange) suitable advice, investigation or treatment where necessary’.
28. The Trust scheduled the repeat biopsy for 14 January. This was 21 days after the initial biopsy. Given the probable success rate of the initial biopsy, the Trust could not have known this test was needed until the biopsy results were processed. This normally takes around a week, and we recognise there were added delays due to the time of year.
29. Taking these factors into account we consider this timeframe was reasonable and a necessary further investigation was ordered in line with GMC guidance.
30. At this appointment the Trust also scheduled a hysteroscopy for 30 January. Unfortunately, the further pipelle biopsy produced the same result and the hysteroscopy could not be completed as the womb could not be fully seen. This meant Mrs B’s symptoms remained undiagnosed.
31. At the time of the hysteroscopy (30 January), Mrs B had been waiting 52 days for a diagnosis. This was significantly over the 28 day target set out in NICE NG12. There had been three inadequate investigations, and there was a high risk she had endometrial cancer (on account of her unexplained bleeding and ultrasound results).
32. On 31 January the Trust decided to offer Mrs B a hysterectomy for both diagnostic purposes and as a treatment for Mrs B’s symptoms. It arranged an appointment to discuss this with her and Mrs B met the consultant on 6 March. The Trust then scheduled a hysterectomy for the 30 March but this was cancelled the day before.
33. Given Mrs B was still awaiting diagnosis and the Trust were significantly over the 28 day target, it is our view the Trust did not arrange the appointment to discuss the treatment (hysterectomy) or offer the treatment promptly enough.
34. This care was not in line with GMC guidance or NICE NG12. This was a failing. We look at the impact of this below.
35. On 13 April, whilst waiting for her hysterectomy to be rescheduled, Mrs B visited the GP with fatigue, weight loss, nausea, pain and a urinary tract infection. The GP felt a lump in her stomach area and ordered an urgent CT scan, which showed cancer.
36. GMC guidance also says, ‘If you assess, diagnose or treat patients you must refer a patient to another practitioner when this suits the patient’s needs’ and ‘In providing clinical care you must consult colleagues where appropriate’.
37. We asked our gynaecology adviser if the diagnosis pathway was what they would expect to see following an unsuccessful first pipelle biopsy.
38. Our gynaecology adviser explained that by 30 January it was clear this case was very complex. They also highlighted the additional complications of Mrs B’s weight which would have made surgical options much more complicated and physical examinations less reliable.
39. Our gynaecology adviser explained Mrs B’s care should have been referred to the gynaecological cancer MDT (a group of experts who advise on assessment and treatment of gynaecological cancers) for discussion and further advice on diagnosis and treatment.
40. Our gynaecology adviser explained it is their view the MDT would have recommended in depth imaging such as a CT scan or MRI scan, as Mrs B’s surgical risk was so high. They explained the risks of these scans were much lower than surgery for Mrs B.
41. Our oncology adviser explained Mrs B had no symptoms of high-grade cancer at this time (such as weight loss, abdominal pain or bloating). They explained at MDT they would have considered a pelvic MRI scan, as this would have likely aided diagnosis and decision making around the suitability of a hysterectomy or CT scan.
42. Whilst the rationale of our advisers differs slightly, both agree imaging would have been considered as part of that discussion, with some form of imaging being a likely outcome.
43. We recognise predicting the outcome of an MDT is very difficult as it involves the opinions of multiple expert professionals and often complex decision-making processes.
44. Based on the evidence available to us we have seen Mrs B’s had significant surgical risks (including her weight and anaesthetic requirements) and the Trust had decided it needed to have two surgeons in the theatre to safely operate (buddy surgery).
45. We are satisfied these factors would have meant a typical MDT would have been more likely than not to agree on some form of imaging as the next step.
46. Considering NICE NG12, GMC guidance and the views of our advisers, we are satisfied the initial testing was appropriate. However the Trust did not act in line with GMC guidance and seek advice and collaboration from an MDT for Mrs B’s complex presentation following the failed hysteroscopy. This was a failing. We look at the impact of this below.
Impact 47. Mrs B was referred for an urgent CT scan on 14 April. She discussed the results at an outpatient appointment on 24 April and following a biopsy on 2 May she received a full diagnosis on 11 May, 154 days after her initial GP referral in December.
48. Had Mrs B been referred to a specialist MDT on 30 January it is likely the MDT (usually held on a weekly basis) would have recommended more in depth imaging (CT or MRI scanning) which would have likely revealed the extent of the cancer.
49. It is likely Mrs B’s referral would have been made around 7 February, meaning she would have received her diagnosis around ten weeks earlier.
50. Mr P told us his mother experienced avoidable uncertainty in this period.
51. Sadly Mrs B’s diagnosis was terminal and this would have remained the case if reached earlier. However we recognise the time Mrs B was waiting for her diagnosis would have been reduced, as would the associated uncertainty. It also would have given Mrs B additional time to understand what was happening, plan and prepare as Mr P states.
52. Mr P also says because of the delays in diagnosis his mother experienced undue worry and stress about surgery that would have been unnecessary.
53. Had the failings not occurred Mrs B would not have been scheduled for surgery, or have met with an anaesthetist, something which caused her considerable worry and distress.
54. We cannot say she would have been without worry in this period, as the worry of surgery and its associated complications would have been replaced with the worry of a terminal diagnosis.
55. However we recognise psychological support is a widely recognised feature of end of life care available to patients with a terminal diagnosis. Mrs B did not have that support in place to access.
56. We were very sorry to see this was her experience. We appreciate this must be difficult for Mr P and the family to know. We make recommendations to address this below.