Acting on ultrasound results in 2016
19. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this and have not seen indications something has gone wrong.
20. Mr P says that Mrs K had two scans in November 2016. He says the Trust identified she had gallstones, but did not explain the diagnosis and risks of them. He says had this been followed up, his wife would have got treatment, and not developed cancer.
21. The relevant guidance for this issue comes from GMC standards ‘Consent: patients and doctors making decisions together’ and ‘Good Medical Practice’. Guidance in the ‘Consent’ document states clinicians must ‘discuss with patients what their diagnosis, prognosis, treatment and care involve.’ In addition, standards from ‘Good Medical Practice’ says doctors must: ‘share all relevant information with colleagues involved in your patients’ care … and when you delegate care.’
22. We asked our adviser what should happen when a patient is referred for a scan and gallstones are identified. Our adviser explained that a GP would usually make a referral for a patient who needs a scan in secondary care. If the scan identifies something significant, like a gallstone, then the results are shared with the GP. It is the GP’s responsibility to share the findings of the scan with the patient and provide further guidance.
23. We considered if the Trust acted correctly, with input from our adviser to help us understand the clinical care. Our adviser said the reason Mrs K was referred, was because she had blood in her urine. To investigate why this was happening, the GP ordered an abdominal ultrasound.
24. The finding of gallstones was likely incidental and is unlikely to have had any connection to blood in her urine. The Trust appropriately shared the results of this with the GP, which was its responsibility. After this, it was the GP’s responsibility to decide whether further action was needed.
25. Our adviser explained that gallstones do not always need to be treated. The only time they should be treated is if they are causing symptoms. There is no evidence that gallstones increase any risks for cancer. If Mrs K was experiencing relevant symptoms because of her gallstones, then further management would be required. However, it was the referring clinician’s responsibility to pass the information to Mrs K (in this case, her GP).
26. We can see the evidence indicates the Trust adhered to the GMC standard to share relevant information with colleagues involved in the patients care. We do not see an indication of failing for this issue.
Providing ERCP treatment
27. Mr P says after Mrs K’s diagnosis, the Trust initially offered treatments including surgery or chemotherapy. He said two weeks later, the Trust wanted to do the ERCP instead. Mr P says this was ill-advised given Mrs K’s condition. He says cancer treatment should have been provided as soon as possible, to give Mrs K a chance of fighting or surviving the cancer.
28. Relevant standards for this issue come from ‘Guidelines for diagnosis and management of cholangiocarcinoma’ and ‘Good Medical Practice’. Good Medical Practice says doctors must ‘prescribe drugs or treatment…only when you have adequate knowledge of the patient’s health and are satisfied that the drugs or treatment serve the patient’s needs.’
29. Management of Cholangiocarcinoma (CCA) guidance says when, ‘undertaking any endoscopic investigations for a suspected CCA, all patients should have undergone a triple-phase CT scan of the abdomen/pelvis and chest along with dynamic MRI and MRCP if proximal biliary obstruction is suspected.’
30. A triple phase CT scan is when detailed images are taken of the organs, using three types of contrast. This helps to create a more detailed image of the internal organs. Biliary obstruction is when the ducts in the biliary tree are blocked.
31. It also says, ‘[p]atients with operable distal malignant tract obstruction (DMTO) should undergo a combination of endoscopic US and endoscopic retrograde cholangiopancreatography (ERCP) to try to confirm a malignant histological diagnosis before proceeding to surgery,’ and that, ‘[i]n cases where rapid access to surgery can be offered, it may be appropriate to bypass biliary drainage at ERCP to avoid ERCP-related complications and postoperative sepsis.’
32. Cholangiocarcinoma is bile duct cancer, which Miss K had. Miss K also had jaundice which means her biliary tree was not able to drain bile. DMTO is when there is a likely tumour obstructing the bile ducts. It was considered likely that Miss K had DMTO early in her care.
33. We asked our adviser what should have happened when making a treatment plan for patients in Mrs K’s condition. They explained Mrs K had obstructive jaundice as well as cancer. Obstructive jaundice is when bile in the biliary tree cannot drain into the small bowel as it is blocked. This creates swelling in the rest of the tree, including in the liver. It can cause liver failure, which can lead to death.
34. Our adviser said in Mrs K’s circumstances relieving obstructive jaundice should be the priority. They said it would then be appropriate to consider whether the cancer was operable and if not, whether chemotherapy could be given.
35. Our adviser said the Trust should have considered whether surgery or chemotherapy would be possible, while planning for jaundice treatment. Evidence in the records indicates, that prior to investigation, the Trust considered Mrs K’s tumour may be operable. However, scans showed her cancer was possibly invading her right hepatic artery. This was confirmed in a further scan on 14 May.
36. Our adviser said because the cancer was affecting the artery, surgery should not have been provided. They said it was then appropriate to focus on reducing bile obstruction and then to reflect on whether chemotherapy would be possible.
37. Our adviser said, there are assessments the Trust should do, to decide if chemotherapy is appropriate. In this case it would mean confirming the cancer diagnosis with a biopsy and ensuring Mrs K’s bilirubin levels was in safe parameters. Bilirubin is a yellow pigment created when red blood cells break down. High bilirubin levels indicate jaundice and poor liver function. Poor liver function can impair drug metabolism and increase the toxic effect of chemotherapy.
38. We understand an oncologist would not agree to provide chemotherapy unless a biopsy had been done which confirmed cancer diagnosis. This is because chemotherapy is highly toxic and providing this treatment when there is a chance the lesion is not cancer is very dangerous.
39. We can see from Mrs K’s medical records the Trust provided a scan on 4 May which demonstrated a thickening in her gallbladder. It provided an MRCP on 9 May which showed a likely cancer. The radiologist recommended a CT scan for staging assessment and to discuss the case at an MDT. CT of Mrs K’s thorax, and abdomen was provided on 14 May. This is in line with the guidance on managing Cholangiocarcinoma above, as relevant scans were performed.
40. The Trust held an MDT on 10 May. Clinicians agreed that Mrs K had a likely cancerous lesion in the gallbladder wall which had spread in the liver. There was also concern her right hepatic artery had been invaded by the tumour (this was confirmed in the scan on 14 May). She also had a bilirubin level of 83. The MDT team also decided that an ERCP should be performed to help drain the bile in Mrs K’s biliary tree and confirm diagnosis of the cancer.
41. Our adviser explained that a bilirubin level of 83 was too high for chemotherapy to take place. Chemotherapy could not take place until this level came down. The best way to make it come down, would have been to treat Mrs K’s jaundice.
42. We can see the evidence indicates the Trust took the appropriate action. The guidance above says not to provide ERCP if rapid surgery can be provided. We can see this was not possible due to the complications of the right hepatic artery being involved with Mrs K’s cancer. Therefore, ERCP was the next appropriate step. Guidance says this should be provided to confirm the diagnosis of cancer, ahead of any other surgery.
43. In addition, chemotherapy could not have been provided ahead of ERCP because of Mrs K’s bilirubin levels and because she needed a confirmed cancer diagnosis to be eligible for treatment. We consider the Trust acted in line with GMC’s standards to provide treatment only when it was sure it will satisfy the patient’s needs.
44. The evidence demonstrates Mrs K needed the ERCP to address the critical condition of obstructive jaundice and to confirm her cancer diagnosis and open possibility to chemotherapy. We do not see any indications of failings in providing the ERCP.
Underqualified endoscopist
45. Mr P explained that the ERCP was a complicated procedure, and his wife was a very serious case. He says the staff member who performed the endoscopy was a trainee and that the Trust should not allow trainees to conduct this procedure in such seriously unwell patients.
46. From Good Medical Practice, the relevant standards state doctors should ‘recognise and work within the limits of your competence.’
47. We asked our adviser if it was appropriate for the Trust to allow a trainee to conduct Mrs K’s ERCP. Our adviser said for a doctor to be capable of performing an ERCP, the endoscopist must have successfully performed hundreds of endoscopies. It is common for a trainee to undertake an ERCP once they have undertaken a significant amount of other endoscopies. This develops a significant level of skill and qualifies them to perform the ERCP safely.
48. Our adviser reviewed the report written by the endoscopist. They said the quality of report demonstrates the competence and skill of the staff member. They explained the report was thorough, and appropriate areas of investigation are listed and reported on in good order, demonstrating the endoscopist was following a system of examination. They also said the detail of the report shows the analysis was performed to a good standard.
49. Our adviser also said the procedure was performed well because the endoscopist successfully installed a stent in Mrs K’s biliary tree. This is a difficult task to perform. The success of the stent being put in place, demonstrates the endoscopist was sufficiently skilled.
50. We asked our adviser if the complications Mrs K suffered, could have been caused by a poorly delivered ERCP. Our adviser explained that there is always a 5-10% risk of patients developing pancreatitis. They said there is no connection between Mrs K’s severe pancreatitis, and the seniority of the endoscopist. They said Mrs K was one of the unfortunate patients who developed severe pancreatitis because of the procedure.
51. We can see the Trust must have strict measures in place to allow the endoscopist to perform the ERCP. In addition, Mrs K’s complications could have happened with a fully qualified endoscopist. Our adviser has also told us the quality of the report was good and demonstrates a systemic approach to the procedure.
52. We think, on the balance of probabilities, the staff member was sufficiently experienced to provide the treatment. The evidence, therefore, indicates the Trust acted in line with the GMC guidance for the staff member to work within their competence. There is no evidence they performed the ERCP poorly and caused Mrs K’s complications. We see no indications of failings on this issue.
Management of post-procedure complications
53. Mr P says the Trust delayed providing effective treatment for Mrs K’s post-procedure infections. He says the Trust provided antibiotics, but these were not working. He says Mrs K had infected fluid in her pancreas but not enough was done to drain the infection. He says very little was done to help improve the situation and after many weeks a procedure was done on 29 June to drain the infected fluid.
54. The practical guide to the management of acute pancreatitis outlines the following standards when managing pancreatitis, ‘Indications to drain pancreatic collections include infection and symptomatic sterile necrosis.’
55. Good Medical Practice also says doctors must, ‘promptly provide or arrange suitable advice, investigations or treatment where necessary.’
56. Our adviser said collections of infected fluid, should be drained. They also explained that antibiotics are provided with input from microbiology who examine samples from the patient and how different antibiotics react. If antibiotics are not effective on the bacteria, microbiology will advise a different kind of antibiotic to be given to the patient.
57. Our adviser also explained that fluid in the pancreas cannot be drained until it has ‘collected’ or ‘organised’. Clinicians must wait for fluid to organise into a ‘bubble’ with a wall which can be penetrated and drained. The way to recognise if fluid has collected is to provide a CT scan. Once the fluid has sufficiently collected, then surgical attempts can be made to drain the fluids.
58. We can see that following ERCP, Mrs K developed severe pancreatitis. This was diagnosed on 19 May. On 24 May another scan was performed which showed necrosis (dead tissue) with presence of gas. Gas can be a sign of infection. There was also fluid in the pancreas which was in the process of organising.
59. The Trust provided additional scans on 24, 25 and 31 May, and 2 June. It provided gastroscopy on 7 June, CT scans on 13 June, endoscopic ultrasound on 23 June, and the first successful drainage of fluid happened on 26 June.
60. The notes on 26 June, demonstrate some reduction in pancreatic collections but say there are specks of air which could be indicative of infection. There are notes indicating multiple areas of drainage needed and that this would very likely lead to sepsis and require High Dependency Unit admission.
61. Prior to the 26 June, we can see some delay in Mrs K receiving the drainage she needed. Notes show Mrs K did not have appropriate clotting levels in her blood for drainage on 19 June. On 20 and 21 June the department lacked staff to undertake the procedure. On 23 June drainage was attempted but was unsuccessful. Complications from this procedure were discussed over the following days until a successful drainage on the 26 June.
62. In addition to the above scans, the Trust provided antibiotic medication to help treat infections. We reviewed the records and could see the Trust provided several courses of antibiotics to Mrs K throughout May and June. Tit also provided a number of different types of antibiotic.
63. Our adviser explained that the antibiotics which were given, demonstrate a robust attempt to bring infection under control. Our adviser said it is common practice to limit antibiotic provision to prevent patients developing a tolerance to bacteria. However, the medications evident in the records, show the microbiologists involved in Mrs K’s care were very concerned.
64. The consistency and strength of the antibiotics she was prescribed is notable. In this case, the Trust took a less cautious approach to microbe resistance, in favour of fighting Mrs K’s current infections as best as it could be done.
65. Our adviser also said that patients would not normally be scanned as regularly as Mrs K was, unless they were severely unwell. In patients unwell with pancreatitis, usually in intensive or high dependency care, doctors would wait seven to ten days before organising a new scan. This is so any changes in the images would be clear enough. Earlier scans can be justified if staff consider the patient is significantly ill.
66. After the ERCP the Trust provided seven examinations, including scans, for Mrs K before her first drainage. This number of investigations and scans is more than would usually be provided and demonstrates the Trust were working very proactively to monitor the fluid collections, infection, and provide appropriate drainage.
67. The Trust should not have attempted to drain the fluid until it was collected. It was noted to be improving on the 13 June, as the CT report says ‘the collections…has increased in size and more organised’. On 14 June, notes say the collection in increasing and on 15 June clinical notes say drainage was booked in for the next day. However, this did not happen. Instead, drainage was finally arranged on 19 June.
68. Notes show unfortunately Mrs K did not have appropriate clotting levels in her blood on 19 June for drainage to go ahead. We can see there were some delays to drainage caused by issues at the Trust. This includes from 16 to 19 June and 20 to 21 June. We asked our adviser if those delays could have worsened Mrs K’s prognosis. Our adviser said those delays were very unlikely to have contributed further to Mrs K’s decline and that she had a very aggressive cancer. Sadly, it was unlikely she would rally from the complications for this reason.
69. We have seen evidence Mrs K was suffering necrosis and infection of fluid collections. In line with guidance, the Trust should have tried to drain the fluid collections. We also have seen this should only happen when fluid is collected and organised. The evidence indicates the Trust tried to promptly arrange treatment for the fluid collections once it had organised. We can see there were some delays. We consider, overall these are not so significant they amount to a failing, and that they would have had little impact on Mrs K’s prognosis.
70. We can also see the Trust consistently adapted its plan for antibiotic treatment with input from microbiology. This was to ensure Mrs K was provided the best strength antibiotics to give her the best chance of fighting her infection. The evidence indicates the Trust acted in line with GMC guidance when providing this treatment. We see no indication of failings for this issue.
71. We recognise that Mr P believes his wife, Mrs K could have had different treatment and that this may have prolonged or even saved her life. We hope that our explanation helps him to understand why the treatment had to happen the way that it did. We also hope it reassures him that the Trust had Mrs K’s best interests at heart.
72. Once again we are very sorry to hear of the devastating loss of Miss K and we wish Mr P and his family some peace as he moves on from his complaint.