Chapter 11 Quality Issues and Measures in ERCP
Endoscopic retrograde cholangiopancreatography (ERCP) is a technically demanding procedure that requires considerable endoscopic skill. It is associated with the highest adverse event rates of any endoscopic procedure. It is important that endoscopists with competency are given privileges for ERCP. In response to this, the American Society for Gastrointestinal Endoscopy (ASGE) has proposed specific criteria for the training and granting of clinical privileges for ERCP.1,2 Institutions may be held legally liable for negligent privileging.3 In the era of evidence-based medicine, the need arises to establish a foundation for quality assurance related to ERCP. For this reason, the ASGE with the American College of Gastroenterology (ACG) proposed specific quality indicators to allow for both measurement and improvement in ERCP. These indicators include both process and outcome measures. Process measures assess actual performance in the delivery of care compared to accepted standards. Outcome measures assess the results of care from the patient’s perspective.
In this chapter we discuss the quality indicators that pertain to ERCP (Table 11.1).1 These indicators are divided into preprocedure, intraprocedure, and postprocedure time frames.4 The preprocedure period includes all contact with the patient up to the administration of sedation or anesthesia. The intraprocedure period is from the time of administration of sedation or anesthesia to endoscope withdrawal. The postprocedure period extends from completion of the procedure through patient follow-up. Each time period has specific indicators associated with it and is considered separately. Additionally there are indicators common to all endoscopic procedures that should be assessed (Box 11.1).
Table 11.1 Quality Indicators for ERCP
| Quality Indicator | Measure Type |
|---|---|
| Appropriate indication | Process |
| Informed consent | Process |
| Assessment of procedural difficulty | Process |
| Prophylactic antibiotics | Process |
| Cannulation rates | Process |
| Use of precut techniques | Process |
| Extraction of CBD stones | Outcome |
| Biliary stent placement | Outcome |
| Complete documentation | Process |
| Adverse event rates: pancreatitis, perforation, cholangitis | Outcome |
| Fluoroscopy time | Process |
CBD, Common bile duct.
Preprocedure Quality Indicators
The preprocedure period includes all contact between the patient and the endoscopy center staff (endoscopist, nurses, technicians, schedulers, etc.) to the initiation of sedation or anesthesia. In addition to the specific ERCP indicators reviewed below, measures common to all endoscopic procedures may be assessed. These include documentation of a focused history and physical examination, risk stratification (American Society of Anesthesiologists [ASA] or Mallampati score), recording a sedation plan, timeliness of the performance of the procedure, addressing the use of anticoagulants or antiplatelet agents, and a preprocedure team pause (see Box 11.1).4
Appropriate Indication
One of the most important quality indicators for ERCP is an appropriate indication.5,6 In the United States, lack of indication for ERCP is the most common reason for legal allegation (see Chapter 12).7 Indications for ERCP vary1,5,6 and include the following:
Clinical, biochemical, or imaging data suggestive of pancreatic or biliary tract disease
Clinical suspicion of pancreatic malignancy when direct imaging studies are normal or equivocal
Evaluation and treatment of idiopathic recurrent pancreatitis
Preoperative evaluation and treatment of chronic pancreatitis
Preoperative evaluation of pancreatic pseudocyst
Stent placement for treatment of
Balloon dilatation of ductal stricture
Drainage of symptomatic and infected pancreatic fluid collections
Tissue sampling of pancreatic or bile ducts
ERCP is generally not indicated in the following clinical scenarios.1,5,6
Abdominal pain without objective evidence of pancreaticobiliary disease. Objective evidence includes abnormal laboratory or imaging studies suggestive of pancreaticobiliary disease. The risk–benefit ratio is high in the absence of these objective findings. If ERCP is pursued for abdominal pain without objective evidence of pancreaticobiliary disease, it is suggested that sphincter of Oddi manometry be performed.8
Routine ERCP prior to cholecystectomy. Preoperative ERCP prior to cholecystectomy should be performed in the setting of acute cholangitis or if the preprocedure likelihood for choledocholithiasis is high (e.g., abnormal imaging showing stones, persistently abnormal liver tests, biliary ductal dilation).9
Routine ERCP for the relief of a malignant biliary obstruction in patients with resectable pancreaticobiliary malignancy. ERCP in this setting has been associated with high preoperative and postoperative adverse events10 as confirmed in a recent randomized prospective trial.8 Nevertheless, ERCP should be considered in the setting of a malignant biliary obstruction in patients with intense pruritus, particularly if there is a delay in surgical resection, or to treat acute cholangitis.10,11
The indication for the procedure should be documented in the medical record. If the ERCP is being performed for nonstandard indications, it should be discussed with the patient in detail and be well documented and justified.1 Further information on the indications and contraindications for ERCP is found in Chapter 6.
Informed Consent
Given the high adverse event rate inherent with ERCP, informed consent must be obtained from the patient or legal guardian prior to the procedure, except in the setting of a life-threatening medical emergency.1 The components of the informed consent process are (1) voluntary consent, (2) a patient or legal guardian capable of rational decision making, and (3) that “adequate information” be conveyed.12 It is the physician’s responsibility to disclose as much information as a reasonable patient would wish to know when making a decision. Determining what is “reasonable” is not a precise science, and the physician must simultaneously balance the need to avoid overwhelming the patient and the need to provide pertinent risk information. The consent should address the most commonly encountered adverse events associated with ERCP and their expected rates. These include pancreatitis, infectious adverse events (cholangitis and cholecystitis, infection of pancreatic fluid collection), postsphincterotomy bleeding, perforation, and sedation-induced cardiopulmonary adverse reactions.1 Although there are differing opinions as to whether patients must be informed of potential need for surgery, prolonged hospital stay, or death,12 we cannot overemphasize the value of extensive patient education about ERCP and its potential adverse events. Disputes about the extent of the education and consent process are common in ERCP lawsuits (see Chapter 12).7 While state laws vary on who can legally obtain informed consent, most experts recommend that the endoscopist performing the procedure obtain the consent.13,14 In a large prospective multicenter study describing the ERCP consent process in England, the majority of endoscopists (84%) obtained the consent themselves, while 14% delegated this responsibility to another member of the team.15
The incidence of post-ERCP pancreatitis (PEP) typically ranges from 1% to 7% but can be higher in certain clinical situations.1,16,17 Multiple studies have identified risk factors for PEP. These factors can be classified into patient-related and procedure-related factors based on prospective studies.18–20 Patient-related factors include a prior history of PEP and known or suspected sphincter of Oddi dysfunction, age less than 60 years, female gender, absence of chronic pancreatitis, and normal serum bilirubin.19,20 Procedure-related factors include more than 1 or 2 pancreatic contrast injections, moderate to difficult cannulation (defined variably but usually 10 or more attempts at cannulation), pancreatic sphincterotomy, precut sphincterotomy, minor papilla sphincterotomy, balloon sphincteroplasty without sphincterotomy, papillectomy, and trainee involvement. Although such factors should be addressed with the patient during the informed consent process,19,20 the optimal degree of explanation (detail) of these factors is unknown and not standardized. However, patients should be informed that pancreatitis can be severe in a small percentage of cases and may require prolonged hospitalization.
Infectious adverse events are uncommon after ERCP. Acute cholangitis complicates up to 1% of ERCP.21,22 Post-ERCP acute cholecystitis is seen in 0.2% to 0.5% of cases.
Post-ERCP bleeding can occur after sphincterotomy, ampullectomy, and transmural drainage of pancreatic fluid collection. Postsphincterotomy bleeding occurs in 0.8% to 2% of cases,22,23 and the possible need for transfusion, surgery, or radiologic embolization should be discussed. The patient’s willingness to receive blood transfusion, if needed, should be discussed and documented.
ERCP-induced perforation can be related to the guidewire (periductal or ductal perforation) or sphincterotomy (duodenal perforation), or endoscope induced at a site remote from the papilla. Post-ERCP perforation occurs in 0.35% to 0.6% of cases18,23 and the potential need for surgery and prolonged hospital stay for this adverse event should be discussed.
Death complicates 0.07% of cases.23,24 Further details on adverse events of ERCP may be found in Chapter 7.
Assessment of Procedural Difficulty
It has been proposed that the degree of ERCP difficulty be classified by a grading system to allow comparisons among endoscopists.25 It is assumed that higher degrees of difficulty are associated with lower success rates and higher rates of adverse events. The three-tier grading system is as follows:
