From the Guidelines
Informed consent for ERCP should include a thorough discussion of the procedure's purpose, benefits, risks, and alternatives, with specific risks disclosed including pancreatitis, bleeding, infection, perforation, and a small risk of death, as well as the possibility of failed cannulation and the potential need for repeat procedures, as stated in the most recent study 1. The physician should explain that ERCP is an endoscopic procedure used to diagnose and treat problems in the bile ducts, pancreatic ducts, and gallbladder.
- Specific risks that must be disclosed include:
- Pancreatitis (occurring in 4% to 5.2% of cases)
- Bleeding (1-2%)
- Infection (1%)
- Perforation (less than 1%)
- Adverse reactions to sedation
- A small risk of death (0.4%) The consent process should also cover the possibility of failed cannulation (5-10% of cases) and the potential need for repeat procedures.
- Patients should be informed about alternatives such as:
- Magnetic resonance cholangiopancreatography (MRCP)
- Endoscopic ultrasound (EUS)
- Surgical options Pre-procedure preparation instructions should be provided, including:
- Fasting for at least 8 hours before the procedure
- Management of anticoagulants or antiplatelets Post-procedure care instructions should also be discussed, including monitoring for complications like abdominal pain, fever, or bleeding, as recommended by the American College of Radiology 1. This comprehensive informed consent process is essential because ERCP carries higher risks than standard endoscopic procedures, and patients need to understand these risks to make an informed decision about proceeding with the procedure, as emphasized in the guidelines for informed consent 1.
From the Research
Informed Consent for ERCP
- The process of informed consent for patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) is crucial for ensuring that patients are aware of the potential risks and benefits associated with the procedure 2, 3.
- A study published in the Journal of digestive diseases found that video education can improve awareness of risks for patients undergoing ERCP, with patients in the video education group showing significantly increased comprehension of ERCP-related complications and higher satisfaction with the informed consent process 2.
- Another study published in the European journal of gastroenterology & hepatology found that the ERCP consent process could be improved by consistent disclosure of risk, acquisition of verbal consent well in advance of the procedure, provision of information after ERCP, and increased attention to older and more sick patients 3.
- The use of rectal indomethacin has been shown to reduce the risk of pancreatitis after ERCP, with studies suggesting that it can be used in both high- and low-risk patients 4, 5.
- However, the use of indomethacin alone may not be as effective as the combination of indomethacin and prophylactic pancreatic stent placement in preventing post-ERCP pancreatitis in high-risk patients 4.
Key Findings
- Video education can improve patient understanding of ERCP procedure and risks 2.
- Consistent disclosure of risk and acquisition of verbal consent well in advance of the procedure can improve the ERCP consent process 3.
- Rectal indomethacin can reduce the risk of pancreatitis after ERCP, but may not be as effective as the combination of indomethacin and prophylactic pancreatic stent placement in high-risk patients 4, 5.
Implications for Informed Consent
- Healthcare providers should consider using video education as a tool to improve patient understanding of ERCP procedure and risks 2.
- The ERCP consent process should include consistent disclosure of risk and acquisition of verbal consent well in advance of the procedure 3.
- Patients should be informed of the potential benefits and risks of rectal indomethacin and prophylactic pancreatic stent placement in preventing post-ERCP pancreatitis 4, 5.