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Objectives: Diseases of the pancreas and biliary tree are common in the United States. Prevalence of common bile duct stones is estimated at 6 per 100,000. Incidence of pancreaticobiliary malignancy is approximately 57,400 annually, most with poor prognosis. A variety of diagnostic and therapeutic interventions have been developed to manage these conditions.
This systematic review of the evidence on the diagnostic and therapeutic effectiveness of endoscopic retrograde pancreatography (ERCP) addresses four clinical conditions:
- Common bile duct stones.
- Pancreaticobiliary malignancy.
- Abdominal pain of possible pancreaticobiliary origin.
In addition, the evidence on determinants of complications of ERCP and on the prediction of common bile duct stones are reviewed.
Search Strategy: The PubMed®/MEDLINE®, BIOSIS, EMBASE, and SCISEARCH databases with a publication date from 1980 through August 13, 2001 were searched for articles indexed to the National Library of Medicine (NLM) Medical Subject Heading (MeSH®) "cholangiopancreatography, endoscopic retrograde" and ERCP synonyms and textword combinations. Search was limited to articles on human subjects published in the English language with an online abstract and supplemented by manual searching. 5,698 citations were yielded.
Selection Criteria: Inclusion was limited to published reports. For diagnostic and therapeutic effectiveness, inclusion was limited to comparative studies prospectively designed or using appropriate retrospective sampling with a prespecified minimum number of subjects. For prediction studies, 100 subjects were required. There were 789 articles retrieved for review, yielding 149 included studies.
Data Collection and Analysis: The protocol was designed prospectively to define: study objectives; search strategy; patient populations; study selection criteria; outcomes; data elements and abstraction; and study quality assessment. One reviewer performed primary data abstraction into evidence tables and a second reviewer checked accuracy. Data synthesis was qualitative.
- Most diagnostic studies were small, did not use common reference standards, and many did not report statistical significance; thus, equivalence and difference among tests cannot be quantified. Qualitative assessment of the available evidence suggests that:
- Magnetic resonance cholangiopancreatography (MRCP) and endoscopic ultrasound (EUS) provide similar diagnostic performance as ERCP for detecting common bile duct stones or malignant pancreaticobiliary obstruction.
- Sensitivity of nonsurgical tissue sampling techniques for detecting malignancy is similar or higher for brush cytology versus bile aspiration cytology, similar for fine-needle aspiration (FNA) cytology versus brush cytology, and similar or higher for forceps biopsy versus brush cytology.
- Robust evidence is lacking to compare strategies for treatment of common bile duct stones.
- The absence of any risk factors for common bile duct stones (i.e., clinical jaundice or elevated bilirubin, elevated liver function tests, dilation on ultrasound) is a strong predictor of the absence of stones.
- For palliation of biliary obstruction of malignancy, outcomes of surgical bypass and ERCP stenting are similar, but major complications are greater for surgery and stent replacement occurs with ERCP. Total resource utilization was reported to be lower with metal than plastic stents. Pre-operative stenting has greater overall complications than surgery alone and does not appear to improve surgical outcomes.
- Evidence on treatment of chronic pancreatitis and relapsing or recurrent pancreatitis is sparse.
- Endoscopic sphincterotomy appears to relieve pain in patients with pancreaticobiliary pain, sphincter of Oddi dysfunction, and elevated basal sphincter of Oddi pressure on manometry.
- Factors associated with complications of ERCP were age 60 years or less, suspected sphincter of Oddi dysfunction, precut endoscopic sphincterotomy, difficulty in cannulation, multiple pancreatic contrast injections, and case volume.
Conclusions: Rigorous studies are required in order to reliably quantify the relative performance of diagnostic ERCP compared to alternatives. Comparative studies of alternative diagnostic and treatment strategies for common bile duct stones are urgently needed. Interventions intended to reduce complications of ERCP should incorporate prospectively defined studies to evaluate results.
Endoscopic Retrograde Cholangiopancreatography
Evidence-based Practice Center: Blue Cross and Blue Shield Association TEC
Topic Nominator: National Institute of Health (NIH) Office of Medical Applications of Research
Current as of March 2001