Manchester University NHS Foundation Trust

The complaint

6. Mr B complains about aspects of care he received from the Trust in December 2024 and May 2025. Specifically, he complains the Trust:

• misidentified the ampulla of Vater, which is a normal anatomical structure, as a duodenal polyp during an endoscopy • incorrectly recorded ‘Post ERCP (endoscopic retrograde cholangiopancreatography) acute pancreatitis’ in his discharge summary despite him not undergoing an ERCP • did not obtain informed consent for an ampullary biopsy performed on 23 May 2025 • did not inform him the biopsy carried a known risk of acute pancreatitis.

7. Mr B says following the biopsy he developed acute pancreatitis and required a seven-day hospital admission. He says this caused severe abdominal pain, weakness, emotional distress and a prolonged recovery period.

8. Mr B says the incident affected his physical health, emotional wellbeing and employment. He says he was unable to return to work, lost income and eventually returned to his home country because of the financial and personal impact the incident had on him.

9. As outcomes to his complaint, Mr B wants acknowledgement of failings, service improvements regarding consent procedures and financial compensation.

10. On 13 December 2024, Mr B underwent an endoscopy at the Trust. An endoscopy is a procedure which uses long thin tube with a small camera inside it to look inside the body. Different types of endoscopies look at different parts of the body. During the procedure, the endoscopist identified what appeared to be a duodenal polyp. Duodenal polyps are abnormal growths found in the duodenum. The duodenum is the first part of the small intestine. Biopsies taken at the time showed potentially premalignant changes. This means there were signs of abnormal changes in the cells which may indicate an increased risk of developing cancer.

11. Due to the biopsy findings, the Trust arranged further investigations, including a repeat upper gastrointestinal endoscopy and colonoscopy. A colonoscopy uses the same method as an endoscopy and checks the inside of the bowels.

12. On 23 May 2025, Mr B underwent the repeat procedures. During this examination, the endoscopist used a side viewing scope which showed the previously suspected polyp was the ampulla of Vater (a small opening in the small intestine) rather than a duodenal polyp.

13. Following discussion with another specialist during the procedure, the decision was made to take biopsies from the ampulla of Vater because of the earlier abnormal histology results.

14. After the procedure, Mr B developed pain in his abdomen and chest and later attended the Emergency Department (ED). He was diagnosed with acute pancreatitis (inflammation of the pancreas) and required a seven-day hospital admission.

15. Mr B later complained the biopsy had been performed without his informed consent and said he had not been warned about the risk of pancreatitis.

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 for each element of Mr B’s complaint, and for the most part, we have not found any indications that something has gone wrong.

20. Where we have identified indications the organisation has got something wrong, we look at whether the events had a negative effect which the organisation has not put right. Having done so, we consider the Trust has already done enough to put right the impact of these events. We will explain the reasons for these decisions in the following sections of our statement.

Initial Endoscopy Findings

21. Mr B says the Trust incorrectly identified the ampulla of Vater as a duodenal polyp during the first endoscopy in December 2024. We understand this has caused him great concern, and we have carefully reviewed the actions taken by the Trust.

22. The Trust explained that the appearance seen during the procedure and the biopsy findings available at the time led the clinicians to suspect a duodenal polyp and arrange further assessment.

23. We have considered the British Society Gastroenterology (BSG) guidance relating to biopsy sampling during endoscopies. The guidance explains that abnormalities with the duodenum and ampullary area can be difficult to distinguish during endoscopy and may require further assessment.

24. The medical records show the initial endoscopy was performed using a forward viewing scope, which our adviser confirmed is standard equipment for this type of assessment. We can see the clinician identified an abnormal area, and the biopsy findings demonstrated potentially pre-malignant changes. Our adviser confirmed these findings were based on the visual information during the procedure.

25. Having reviewed all the available evidence, including the biopsy results and findings at the time, Including the biopsy results and findings at the time, we are satisfied it was reasonable for clinicians to suspect a duodenal polyp based on the appearance seen during the procedure. The decision to arrange further assessment consistent with the BSG guidance quoted above which advises on additional investigation where distinguishing between abnormalities is challenging.

26. We have therefore not seen indications the Trust acted incorrectly or outside accepted clinical standards when recording the finding of this endoscopy. We hope this explanation reassures Mr B the actions taken by the clinicians were appropriate given the circumstances and evidence available at the time.

Consent and biopsy procedure

27. Mr B says he did not consent to a biopsy being taken from the ampulla of Vater and was not informed that the procedure carried a risk of acute pancreatitis. Mr B says the biopsy caused acute pancreatitis, resulting in severe pain and a seven day hospital admission. We acknowledge the significant distress and impact this situation had on Mr B and his health.

28. In response to Mr B’s complaint, the Trust explained the purpose of the second endoscopy was to take further biopsies from the suspected duodenal polyp for testing. This was due to the concerns about potentially premalignant changes.

29. The Trust said it was not possible to predict that the suspected polyp would later be identified as the ampulla of Vater and explained that even if it could have anticipated this, it would not have specifically stated the biopsy of the ampulla of Vater on the consent form.

30. Further to this, the Trust explained that during the procedure, when it was recognised that the previously reported duodenal polyp was actually the ampulla of Vater, the consultant consulted with their colleagues in order to decide on whether a biopsy was clinically indicated. The Trust concluded, based on the findings of the previous biopsies, it would have been ‘neglectful’ to not take further biopsies.

31. The Trust acknowledged Mr B developed pancreatitis following the biopsy and apologised for the distress this caused and explained that pancreatitis is a recognised complication of ampullary biopsy. It felt Mr B had been adequately consented for the endoscopy with biopsies and commented that specifying every possible complication is ‘impractical and impossible’.

32. We have considered the BSG guidance relating to biopsy sampling during endoscopies. This guidance explains further biopsies may be clinically necessary to clarify findings where abnormalities are identified during the procedure. It also recommends if there is uncertainty over the lesions identified, clinicians should obtain adequate photo documentation, use image enhancement tools and discuss concerns with a specialist where there is uncertainty. The guidance highlights that biopsy of the ampulla is associated with a small risk of pancreatitis.

33. The medical records show the repeat procedure was performed using a side viewing scope. During the procedure, the clinicians identified that the previously suspected duodenal polyp was in fact the ampulla of Vater. We can see this was discussed with other specialists at the time of the endoscopy before deciding whether to proceed. We understand this decision was made collectively due to the previous abnormal histology findings and the risks they posed.

34. Having reviewed the records, the BSG guidance and the clinical advice, we consider there are indications the decision to proceed was consistent with accepted practice and was done so in Mr B’s best interests given the earlier abnormal biopsy results.

35. With regards to consent, we have considered the General Medical Council guidance on decision making consent. The guidance explains that patients should be provided with information about material risks when seeking consent. It also recognises it would not be reasonable to share every possible risk of harm, potential complication, or side effect. Instead, the discussion should be tailored to the specific circumstances of the procedure and the patient.

36. We can see the Trust relied upon general consent for an endoscopic assessment and biopsy. We have considered the records alongside our clinical advice, and consider the Trust followed the appropriate process for obtaining this consent and informing Mr B of the relevant risks related to this procedure.

37. However, we acknowledge there is no evidence of a separate consent discussion relating to ampullary biopsy or the specific risk of pancreatitis. We have considered whether the absence of a discussion about the specific risk of pancreatitis meant consent was inadequate.

38. The need for an ampullary biopsy only became apparent during the procedure, which meant it could not reasonably have been predicted beforehand. By the time the clinicians identified the ampulla of Vater during the procedure, Mr B had already received sedation. We recognise it would not have been practical or possible for the clinicians to obtain Mr B’s consent at that stage of the procedure. As outlined above, the records show the clinician paused to seek advice on whether further biopsies were clinically indicated before proceeding based on the earlier abnormal biopsy findings.

39. Taking all of this into consideration, we are satisfied the evidence indicates the Trust acted in line with GMC’s decision making and consent guidance and followed the appropriate process for consenting Mr B for an endoscopic assessment and biopsy. The absence of a separate discussion about the ampullary biopsy and the risk of pancreatitis does not indicate the consent process was inadequate.

40. In conclusion, we are satisfied the Trust acted reasonably by relying on the existing consent for the ampullary biopsy and that the decision to proceed was made in Mr B’s interest based on the clinical information available at that time. However, we also acknowledge the significant distress Mr B experienced as a result of developing pancreatitis and we do wish to diminish the impact this had on him.

Discharge Summary

41. Mr B complained the discharge summary incorrectly referred to “post ERCP acute pancreatitis” despite him not undergoing an ERCP. We recognise this error may have caused confusion and concern for Mr B, and we acknowledge the impact this had on him.

42. In response to the complaint, the Trust acknowledged this was an error and apologised to Mr B during a later appointment.

43. In assessing whether the Trust’s response to this error was appropriate, we referred to the NHS Complaint Standards. These standards emphasise the importance of recognising mistakes, providing clear and meaningful apologies, and taking steps to learn from complaints to prevent similar errors in the future.

44. We can see the Trust acted in line with these standards by acknowledging what went wrong and providing an apology to Mr B. Having reviewed the medical records, we have not seen any evidence the error affected Mr B’s subsequent treatment, clinical care or overall outcome.

45. Having considered the impact of the error and the action taken by the Trust we are satisfied the apology was an appropriate response in the circumstances.

46. While we appreciate Mr B’s concerns about this error, we have not seen evidence the inaccurate record caused a significant injustice that would warrant further investigation. We hope this explanation provides further reassurance to Mr B

Conclusion

47. We have carefully considered all the available evidence, including Mr B’s account of what happened, the medical records, relevant guidance, the Trust’s response and independent clinical advice.

48. While we recognise the events Mr B experience may have caused him worry and frustration, and we appreciate the lasting impact it has had on him, the evidence we have reviewed does not indicate the Trust acted outside accepted standards of care.

49. We thank Mr B for bringing his complaint to our attention. We hope our explanation reassures him we have carefully considered the concerns he raised.

1. We have carefully considered Mr B’s complaint about the care and treatment he received from Manchester University Foundation Trust (the Trust).

2. We are sorry to hear of the distress and pain Mr B experienced following the procedure in May 2025. We appreciate the time he has taken to bring his concerns to our attention.

3. After careful consideration, we have not seen indications the Trust acted outside relevant standards and guidelines when identifying the ampulla of Vater during the endoscopy or when deciding to proceed with the biopsies.

4. While we acknowledge Mr B was not specifically informed during the procedure about the additional biopsy or the associated risk of pancreatitis, the evidence indicates the procedure, and biopsies were clinically reasonable and carried out in his best interest.

5. We recognise Mr B suffered acute pancreatitis following the biopsy procedure, which required hospital admission and caused significant pain and disruption to his life. We do not wish for our decision to diminish the impact this had on him. We hope our explanation below reassures him we have carefully considered all aspects of his complaint.