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.

Endoscopic Sphincterotomy with Large Balloon Dilation versus Endoscopic Sphincterotomy for Bile Duct Stones: A Systematic Review and Meta-Analysis

“…However, when faced with more challenging situations, for example, in patients with large or multiple stones and tapered or tortuous distal common duct, additional techniques such as mechanical lithotripsy may be utilized [ 2 , 3 ]. Furthermore, EST and stone removal can result in adverse events, including bleeding, pancreatitis, perforation, and cholangitis [ 4 , 5 ].…”

Risk Factors for ERCP-related Complications and what is the specific role of ASGE Grading System

“…[ 4 5 18 19 21 ] Compared to other endoscopic procedures, ERCP carried the highest risk of complications; most of which are of mild-to-moderate severity. [ 4 6 22 23 ] Some prophylactic strategies were found to be relatively effective in reducing post-ERCP complications and especially pancreatitis. [ 24 ] The use of somatostatin or gabexate, prophylactic pancreatic stent placement, and patient stratification were applied but definite prophylaxis is still open to discussion.…”

“…[ 1 ] ERCP is a high-risk procedure with 5%–10% of mild-to-severe complications, such as pancreatitis, bleeding, perforation, and infection. [ 2 3 4 5 6 ] Pancreatitis is the most common complication but various studies show different frequencies of sequels, which may be due to discrepancy in ERCP difficulty or target populations. [ 6 7 ] Numerous physicians, patients, and procedure-based risk factors are related to post-ERCP complications.…”

“…[ 2 3 4 5 6 ] Pancreatitis is the most common complication but various studies show different frequencies of sequels, which may be due to discrepancy in ERCP difficulty or target populations. [ 6 7 ] Numerous physicians, patients, and procedure-based risk factors are related to post-ERCP complications. [ 8 9 10 11 ] By precise identification of risk factors, ERCP can be avoided in high-risk groups, and to reduce cost in low-risk cases, it can be done in an outpatient setting.…”

Predictors of Choledocholithiasis in Cholecystectomy Patients and Their Cutoff Values and Prediction Model in Korea in Comparison with the 2019 ASGE Guidelines

“…9 Therefore, ERCP should be conducted for therapeutic purposes. 10 In the 1990s, both endoscopic ultrasound (EUS) and magnetic resonance cholangiopancreatography (MRCP), which are low-risk diagnostic modalities, were introduced as alternative diagnostic modalities to ERCP for detecting CBD stones. 11 In 2019, the American Society for Gastrointestinal Endoscopy (ASGE) revised its clinical guidelines for diagnosing and managing patients with calculous cholecystitis or symptomatic cholelithiasis, using clinical predictors to identify risk groups for choledocholithiasis.…”