Complications of ERCP: ethical obligations and legal consequences

Abstract

Endoscopic retrograde cholangiopancreatography (ERCP) is a skill and technique demanding high-risk procedure with an overall complication rate of about 5-10%. Pancreatitis remains the most common complication of ERCP, however, bleeding after sphincterotomies, infections and cardiopulmonary complications as well as perforations may also occur. Patient- and procedure-related risk factors of ERCP complications are mainly predictable so that ERCP often can be avoided and substituted for alternative imaging techniques, especially in high-risk patients. Written consent should be obtained for any ERCP to provide documentary evidence that explanation of the proposed procedure and endoscopic treatment was given and that consent was sought and obtained. The investigating doctor remains responsible for ensuring sufficient time for the patient's questions and to make informed decision before the start of any procedure. The most common legal consequence of an ERCP complication is a civil negligence claim for compensation, however, a clinician may in rare cases be faced with criminal proceedings where there is evidence of gross negligence. Analysis of claims against gastroenterologists suggests the conclusion that ERCP should be done for good indications, by trained endoscopists with standard techniques, with good, documented, patient-informed consent and communication before and after the procedure.