Royal Surrey NHS Foundation Trust

5. Mrs L complains about aspects of the care and treatment she received at Royal Surrey NHS Foundation Trust (the Trust) during and following an Endoscopic Retrograde Cholangiopancreatography (a procedure that combines gastrointestinal endoscopy and X-rays to find and treat problems of the bile and pancreatic ducts) (ERCP) between 16 April and 4 May 2024.

6. Mrs L says the ERCP April 2024 resulted in several complications. Specifically, she complains the Trust failed to identify post-procedure complications, recognise a significant medical incident and provide a treatment plan.

7. Mrs L also complains the Trust poorly communicated with both herself and her daughter when she was incapacitated.

8. Mrs L says because of the ERCP she experienced a perforated duodenum (the first part of the small intestine) and a perforated pancreas which led to pancreatis.

9. Mrs L says because of the failings and delay in her receiving medical treatment she experienced:

• paralysis of the bowel • acute kidney injury and • excessive free fluid in the abdomen which pushed into the diaphragm which caused multiple pulmonary embolisms and consolidation (when the air in the small airways of the lungs is replaced with a fluid, or other material).

10. Mrs L says she was scared, frustrated, anxious and distressed during her inpatient stay. She says the poor communication worsened these feelings. She says she felt afraid and vulnerable and has been left with post-traumatic stress disorder (PTSD).

11. Mrs L is seeking service improvements.

12. On 16 April 2024, Mrs L was admitted to the Trust as a day case for an ERCP. This was due to her having gallstones and a stone in her bile duct.

13. Due to complications of the ERCP, Mrs L remained an inpatient for recovery. She was treated for ‘severe post ERCP pancreatitis [inflammation of the pancreas) and retroperitoneal duodenal perforation [a tear in part of the small intestine]’.

14. Mrs L had a laparoscopic cholecystectomy (keyhole surgery to remove the gallbladder) on 3 May. The Trust discharged her on 4 May.

19. Mrs L complains about the ERCP the Trust performed on 16 April 2024. She says the Trust failed to identify significant post-procedure complications which required her to remain an inpatient until 4 May 2024. We understand the importance of this complaint to Mrs L. We recognise this was an emotionally distressing experience for Mrs L and her family.

20. We have considered all parts of Mrs L’s complaint combined, as each part is interlinked.

21. In its response, the Trust apologised for the known complications Mrs L experienced and recognised this would have been an unpleasant experience for Mrs L and her family. It detailed her medical history and reason for the ERCP which was gallstones in her main bile duct. The Trust noted that this can cause serious, and life threatening, complications such as pancreatitis which necessitated her ERCP referral. The Trust said it discussed the potential risks and complications of the procedure with Mrs L.

22. The Trust explained when Mrs L was seen in the recovery area post procedure there were concerns, she was experiencing minor pancreatitis and as such she was admitted for an overnight stay. It said when Mrs L was seen a day later, her condition had deteriorated. The Trust explained a CT scan of Mrs L’s chest and abdomen then showed multiple pulmonary embolisms, lower lung consolidation and increase of fluid in the abdomen which was linked to the pressure of the pancreatitis.

23. The Trust said it spoke with Mrs L in person and communicated with her daughter through FaceTime (video call) to discuss the findings of the CT scan. It apologised if Mrs L’s daughter felt this was hasty and explained the doctor was keen to liaise with a colleague to action the treatment plan.

24. The Trust recognised the significant complications Mrs L experienced needed proactive management and noted Mrs L was reviewed by the nutrition, surgical and medical teams when she admitted for her inpatient stay.

25. The Trust apologised Mrs L felt communication was lacking and that staff did not update her daughter. The Trust noted a video call was held on 18 April between the consultant and Mrs L’s daughter to provide an update on her treatment plan.

26. The Trust said learning taken from Mrs L’s complaint would be raised anonymously with the nursing team to continue to improve patient experience.

27. Mrs L’s ERCP procedure was carried out to remove gallstones from her bile duct.

28. Our adviser explained the records show this was completed successfully. The United European Gastroenterology Journal (UEGJ) on post-ERCP pancreatitis explains that a known complication of this procedure is inflammation of the pancreas, called post-ERCP pancreatitis (PEP). This is noted as the most common serious side effect.

29. Our adviser explained that a tear in the wall of the bowel, called a duodenal perforation, is also a recognised complication, though this happens less often. The UEGJ details the occurrence rate, and it notes that pancreatitis after ERCP occurs in about three to 10 people out of every 100 and perforations occur in less than 1 in 1000 cases.

30. Our adviser explained PEP is defined by abdominal pain and elevated pancreatic enzymes after the procedure, with severity classified by the need for extended hospitalisation. Following an ERCP, symptoms of pancreatitis typically appear within 24 hours. The time varies depending on the severity, from a few days for mild cases to months for severe cases involving complications.

31. The UGEJ on post-ERCP pancreatitis classifies it into mild, moderate, and severe cases. It says mild pancreatitis requires a two to three day hospital stay and most patients will improve within a week with no further concerns. Moderate pancreatitis requires a four to ten day hospital stay with a longer recovery period. Whilst severe pancreatitis requires a longer inpatient stay as complications can persist or continue to worsen.

32. In Mrs L’s case, the small tube leading from the pancreas was entered before the bile duct was successfully cannulated, and a small cut (sphincterotomy) was made to allow the stones to be removed. Our adviser explained both steps are known to slightly increase the risk of pancreatitis and, in rare cases, perforation.

33. Our adviser noted there is a comprehensive Trust patient information sheet regarding ERCP included within Mrs L’s records which notes pancreatitis and bowel perforation with local incidence rates as complications of an ERCP. Additionally, we can see there is a consent form, dated 16 April 2024, which acknowledges the risks and incidents of complications. We consider the Trust ensured Mrs L was informed of the known complications prior to her procedure.

34. Mrs L was seen by a doctor post procedure and reported severe abdominal pain and abdominal tenderness. The Trust admitted her for an overnight stay as there were concerns of pancreatitis. Pancreatitis was confirmed by a raised serum amylase (an enzyme produced by the pancreas). Our adviser notes an upright chest X-ray did not show any signs of perforation though the Trust requested a CT scan of Mrs L’s abdomen for further investigation.

35. Our adviser explained the day after her ERCP the records note that Mrs L’s symptoms had improved. However, at 48 hours post-procedure, the records note that her condition had worsened, and the CT scan confirmed the diagnosis of acute pancreatitis with a small retroperitoneal (behind the abdominal cavity) perforation.

36. Based on the information available and the advice received, we consider the Trust did identify Mrs L was experiencing complications post ERCP. We have seen this is recorded in the records. It noted the abdominal pain she was experiencing, admitted her in for overnight observations and undertook additional testing to confirm pancreatitis and the severity within 48 hours of her procedure. We consider this was completed within a timely manner once Mrs L’s post procedure complications were identified.

37. When the Trust identified Mrs L’s complication and the severity of her pancreatitis, it began a full review. The Trust established a multi-disciplinary team (MDT) which included the medical gastroenterology team, hepatobiliary surgical team, critical care outreach, pain team, and physiotherapy.

38. On 18 April, the Trust carried out its Duty of Candour and informed Mrs L and her daughter of the complications and plan for treatment.

39. Duty of Candour is a legal obligation for health and social care organisations that ensures providers are open and transparent with people who use its services. Duty of Candour sets out specific requirements providers must follow when things go wrong with care and treatment, including informing people about the incident, providing reasonable support, providing truthful information and an apology when things go wrong.

40. A notifiable safety incident is any unintended or unexpected incident during care that either caused, or could have caused, death, severe harm, moderate harm, or prolonged psychological harm to a patient.

41. We consider the MDT and conversation on the 18 April indicates the Trust did acknowledge Mrs L’s complication as a significant medical incident in an appropriate time and in line with NG104.

42. Our adviser noted the gastroenterology team had started standard care for pancreatitis on 16 April, including stopping oral intake, giving fluids through a drip, and providing pain relief and supportive medications.

43. Following the identification of Mrs L’s complications and established MDT, the Trust created a treatment plan for the conservative (non-surgical) management of the pancreatitis and retroperitoneal perforation.

44. On 19 April, the records detail the Trust’s hepatobiliary surgical team reviewed Mrs L. We have seen the Trust noted her clinical condition and results of the CT scan which showed widespread fluid throughout the abdomen. Our adviser explained this was secondary to Mrs L’s pancreatitis.

45. The treatment included intravenous fluids and nutrition, pain relief, and medications for nausea and stomach protection. The care was jointly managed by the gastroenterology and surgical teams, and the investigations and ongoing treatment plan were explained to Mrs L’s daughter.

46. Once Mrs L was stable, her gallstones were treated with cholecystectomy (surgery to remove the gallbladder) before discharge.

47. Having taken into consideration the available evidence, we consider the Trust recognised Mrs L’s complications as a significant medical incident and established a treatment plan in a timely manner.

48. We have seen throughout her inpatient stay the Trust documented discussions it had with both Mrs L and her daughter whilst it investigated the severity of Mrs L’s pancreatitis.

49. We have listened when Mrs L has told us that the discussions her daughter had with clinicians at the Trust required effort and initiative from her daughter to chase and pursue. We understand how difficult and distressing it must have been for Mrs L’s daughter to feel out of the loop during such a critical time. When a loved one is in serious condition, we recognise that clear and timely communication is important. We understand Mrs L and her daughter feel the communication during this time did not meet their expectations. We recognise how this added to their anxiety.

50. We are satisfied that the Trust communicated with Mrs L’s family adequately during her inpatient stay and recovery.

51. We have not seen any indication the Trust’s care and treatment of Mrs L post ERCP fell below the expected standard of care as detailed in NG104 guidance on managing acute and chronic pancreatitis in patients and are unlikely to uphold this complaint.

52. We understand this complaint is very important to Mrs L. We do not wish to diminish what Mrs L told us about her experience and the significant emotional distress she suffered. We appreciate this response may not offer the closure Mrs L wanted. We hope our explanation offers her reassurance and are sorry for any further distress this may cause.

1. Mrs L complains to us about complications and failings in care following a procedure the Trust carried out on her in April 2024.

2. We were sorry to hear of the significant emotional and mental distress that Mrs L experienced due to her post-procedure complications. We have listened to Mrs L when she has told us this had a lasting effect on her well-being and recovery. We appreciate Mrs L had a lot of concerns about her care and recognise the importance of this complaint to Mrs L and her family.

3. We have not seen anything went wrong in how the Trust performed Mrs L’s ERCP. We consider the Trust acted in line with relevant guidance when it identified Mrs L was experiencing complications post-procedure. We also consider the Trust communicated appropriately with Mrs L and her daughter after the ERCP.

4. We have carefully considered the evidence we have been given. We have not seen any indication of failing and therefore do not uphold Mrs L’s complaint. We thank Mrs L for bringing her complaint to us and we hope she will find our decision useful in confirming we have not seen any indications that something went wrong with her care.