E n d o s c o p i c R e t ro g r a d e C h o l a n g i o p a n c rea t o g r a p h y – Related Adverse Events General Overview Tarun Rustagi,
MD,
Priya A. Jamidar,
MD*
KEYWORDS ERCP Risk factors Sphincterotomy Pancreatitis Bleeding Complications Cholangitiis Perforation KEY POINTS Diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP) has been a major advance in medicine. A good understanding of patient-related and procedure-related risk factors is important for ERCP, as is the judicious selection of patients. Overall adverse event rates for ERCP are typically reported as 5–10%. The most commonly reported adverse events include post-ERCP pancreatitis, bleeding, perforation, cholangitis, and cardiopulomary or sedation related events. Strategies to minimize, recognize, and manage adverse events are key skills necessary for the practicing endoscopist.
INTRODUCTION
Endoscopic retrograde cholangiopancreatography (ERCP) was first performed in 1968 and the first sphincterotomy was carried out in 1974. ERCP has evolved into a routine endoscopic procedure, with approximately 500,000 procedures performed in the United States and 1.3 million worldwide annually. Most procedures in the United States are therapeutic. ERCP represents a monumental advance in the management of patients with pancreaticobiliary diseases, but is a complex and technically demanding procedure with the highest inherent risk for adverse events of all routine endoscopic procedures. This article evaluates patient-related and procedure-related
The authors disclose that there are no potential conflicts of interest (financial, professional, or personal) that are relevant to the article. Section of Digestive Diseases, Department of Internal Medicine, Yale University School of Medicine, 333 Cedar Street, 1080 LMP, New Haven, CT 06520, USA * Corresponding author. Section of Digestive Diseases, Yale University School of Medicine, 333 Cedar Street, 1080 LMP, PO Box 208019, New Haven, CT 06520-8019. E-mail address: [email protected] Gastrointest Endoscopy Clin N Am 25 (2015) 97–106 http://dx.doi.org/10.1016/j.giec.2014.09.005 giendo.theclinics.com 1052-5157/15/$ – see front matter Ó 2015 Elsevier Inc. All rights reserved.
98
Rustagi & Jamidar
risk factors for ERCP-related adverse events, and discusses strategies for the diagnosis and management of these events. GENERAL CONSIDERATIONS
Before considering performing an ERCP, the endoscopist must ensure there is an appropriate indication. There has been a dramatic reduction in diagnostic ERCPs given the increased use of less invasive imaging modalities to view the pancreaticobiliary system (eg, MRI, computed tomography, and endoscopic ultrasonography [EUS]). Endoscopists must also consider if they have adequate volume to maintain their ERCP skills and minimize adverse events. Overall adverse event rates for ERCP are typically reported as 5% to 10%. The most commonly reported complications include post-ERCP pancreatitis (PEP), bleeding, perforation, infection (cholangitis), and cardiopulmonary or sedation-related events. This article reviews these adverse events and its companion article elsewhere in this issue by Drs Rustagi and Jamidar focuses solely on PEP. POST–ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PANCREATITIS
Given the importance of this topic and the large amount of published data, PEP is covered in greater detail in the accompanying article by Drs Rustagi and Jamidar focuses on PEP. This section provides a brief overview of the subject. PEP is one of the most common and feared adverse events of ERCP, resulting in considerable morbidity and, rarely, death. Several patient-related (younger age, female gender, history of previous PEP, nondilated ducts, normal bilirubin level, suspected sphincter of Oddi dysfunction) and procedure-related factors (difficult cannulation, multiple pancreatic injections, pancreatic sphincterotomy, precut sphincterotomy, pancreatic sampling) have been identified as increasing the risk of PEP.1–9 Therefore, careful patient selection and sound endoscopic technique are the cornerstones in the prevention of PEP. Prophylactic pancreatic duct stenting, particularly in high-risk patients, has been shown to reduce the incidence and severity of PEP by mechanically facilitating pancreatic drainage.10–15 In addition, chemoprophylaxis of PEP has been extensively researched in an attempt to prevent or reduce the severity of PEP. Numerous trials studying a variety of pharmacologic agents (eg, somatostatin, octreotide, corticosteroids, allopurinol, protease inhibitors, nitroglycerin) have yielded disappointing results16–21; however, an important exception is rectal administration of nonsteroidal anti-inflammatory drugs (NSAIDs), which have been shown in large randomized controlled trials and meta-analyses to significantly reduce the incidence and severity of PEP.14,22–28 BLEEDING
Bleeding observed at the time of or after ERCP is usually related to endoscopic sphincterotomy. Bleeding seen endoscopically during or immediately after sphincterotomy is not uncommon, but is generally not considered an adverse event unless there is clinically significant blood loss, transfusion, or a major change in management. The true incidence of significant ERCP-related hemorrhage is variable and difficult to define given the lack of a standard definition. Some degree of bleeding (ranging from oozing to severe bleeding) is seen at the time of sphincterotomy in up to 10% to 30% of cases.5 However, endoscopists are generally unconcerned about minor bleeding, such as limited oozing immediately after a sphincterotomy, because in most cases this is temporary and stops spontaneously.4 When applying clinical criteria
ERCP-Related Adverse Events
such as melena, hematemesis, a greater than 2 g/dL drop in hemoglobin level, or requirement for secondary intervention such as endoscopy or blood transfusion, the overall incidence of bleeding is around 0.1% to 2%.3–5,7,8,29,30 Based on severity, bleeding has been classified into 4 groups: (1) mild (clinical evidence for bleeding but drop in hemoglobin is
MD,
Priya A. Jamidar,
MD*
KEYWORDS ERCP Risk factors Sphincterotomy Pancreatitis Bleeding Complications Cholangitiis Perforation KEY POINTS Diagnostic and therapeutic endoscopic retrograde cholangiopancreatography (ERCP) has been a major advance in medicine. A good understanding of patient-related and procedure-related risk factors is important for ERCP, as is the judicious selection of patients. Overall adverse event rates for ERCP are typically reported as 5–10%. The most commonly reported adverse events include post-ERCP pancreatitis, bleeding, perforation, cholangitis, and cardiopulomary or sedation related events. Strategies to minimize, recognize, and manage adverse events are key skills necessary for the practicing endoscopist.
INTRODUCTION
Endoscopic retrograde cholangiopancreatography (ERCP) was first performed in 1968 and the first sphincterotomy was carried out in 1974. ERCP has evolved into a routine endoscopic procedure, with approximately 500,000 procedures performed in the United States and 1.3 million worldwide annually. Most procedures in the United States are therapeutic. ERCP represents a monumental advance in the management of patients with pancreaticobiliary diseases, but is a complex and technically demanding procedure with the highest inherent risk for adverse events of all routine endoscopic procedures. This article evaluates patient-related and procedure-related
The authors disclose that there are no potential conflicts of interest (financial, professional, or personal) that are relevant to the article. Section of Digestive Diseases, Department of Internal Medicine, Yale University School of Medicine, 333 Cedar Street, 1080 LMP, New Haven, CT 06520, USA * Corresponding author. Section of Digestive Diseases, Yale University School of Medicine, 333 Cedar Street, 1080 LMP, PO Box 208019, New Haven, CT 06520-8019. E-mail address: [email protected] Gastrointest Endoscopy Clin N Am 25 (2015) 97–106 http://dx.doi.org/10.1016/j.giec.2014.09.005 giendo.theclinics.com 1052-5157/15/$ – see front matter Ó 2015 Elsevier Inc. All rights reserved.
98
Rustagi & Jamidar
risk factors for ERCP-related adverse events, and discusses strategies for the diagnosis and management of these events. GENERAL CONSIDERATIONS
Before considering performing an ERCP, the endoscopist must ensure there is an appropriate indication. There has been a dramatic reduction in diagnostic ERCPs given the increased use of less invasive imaging modalities to view the pancreaticobiliary system (eg, MRI, computed tomography, and endoscopic ultrasonography [EUS]). Endoscopists must also consider if they have adequate volume to maintain their ERCP skills and minimize adverse events. Overall adverse event rates for ERCP are typically reported as 5% to 10%. The most commonly reported complications include post-ERCP pancreatitis (PEP), bleeding, perforation, infection (cholangitis), and cardiopulmonary or sedation-related events. This article reviews these adverse events and its companion article elsewhere in this issue by Drs Rustagi and Jamidar focuses solely on PEP. POST–ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PANCREATITIS
Given the importance of this topic and the large amount of published data, PEP is covered in greater detail in the accompanying article by Drs Rustagi and Jamidar focuses on PEP. This section provides a brief overview of the subject. PEP is one of the most common and feared adverse events of ERCP, resulting in considerable morbidity and, rarely, death. Several patient-related (younger age, female gender, history of previous PEP, nondilated ducts, normal bilirubin level, suspected sphincter of Oddi dysfunction) and procedure-related factors (difficult cannulation, multiple pancreatic injections, pancreatic sphincterotomy, precut sphincterotomy, pancreatic sampling) have been identified as increasing the risk of PEP.1–9 Therefore, careful patient selection and sound endoscopic technique are the cornerstones in the prevention of PEP. Prophylactic pancreatic duct stenting, particularly in high-risk patients, has been shown to reduce the incidence and severity of PEP by mechanically facilitating pancreatic drainage.10–15 In addition, chemoprophylaxis of PEP has been extensively researched in an attempt to prevent or reduce the severity of PEP. Numerous trials studying a variety of pharmacologic agents (eg, somatostatin, octreotide, corticosteroids, allopurinol, protease inhibitors, nitroglycerin) have yielded disappointing results16–21; however, an important exception is rectal administration of nonsteroidal anti-inflammatory drugs (NSAIDs), which have been shown in large randomized controlled trials and meta-analyses to significantly reduce the incidence and severity of PEP.14,22–28 BLEEDING
Bleeding observed at the time of or after ERCP is usually related to endoscopic sphincterotomy. Bleeding seen endoscopically during or immediately after sphincterotomy is not uncommon, but is generally not considered an adverse event unless there is clinically significant blood loss, transfusion, or a major change in management. The true incidence of significant ERCP-related hemorrhage is variable and difficult to define given the lack of a standard definition. Some degree of bleeding (ranging from oozing to severe bleeding) is seen at the time of sphincterotomy in up to 10% to 30% of cases.5 However, endoscopists are generally unconcerned about minor bleeding, such as limited oozing immediately after a sphincterotomy, because in most cases this is temporary and stops spontaneously.4 When applying clinical criteria
ERCP-Related Adverse Events
such as melena, hematemesis, a greater than 2 g/dL drop in hemoglobin level, or requirement for secondary intervention such as endoscopy or blood transfusion, the overall incidence of bleeding is around 0.1% to 2%.3–5,7,8,29,30 Based on severity, bleeding has been classified into 4 groups: (1) mild (clinical evidence for bleeding but drop in hemoglobin is
