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Endoscopic ultrasonography versus cholangiography for the diagnosis of choledocholithiasis

Endoscopic ultrasonography versus cholangiography for the diagnosis of choledocholithiasis

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Published by Ossama Abd Al-amier
Endoscopic ultrasonography versus
cholangiography for the diagnosis of
choledocholithiasis
Endoscopic ultrasonography versus
cholangiography for the diagnosis of
choledocholithiasis

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Published by: Ossama Abd Al-amier on Aug 06, 2013
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Endoscopic ultrasonography versuscholangiography for the diagnosis ofcholedocholithiasis
Marcia Irene F. Canto, MD, MHS, Amitabh Chak, MD, Thomas Stellato, MD, Michael V. Sivak, Jr., MD
 Background 
: Choledocholithiasis is a major source of morbidity amongpatients undergoing cholecystectomy for symptomatic gallstones. There isno consensus on the best approach to diagnosing bile duct stones. Wecompared the safety, accuracy, diagnostic yield, and cost of EUS- andERCP-based approaches.
 Methods
: Sixty-four consecutive pre- and post-cholecystectomy patientsreferred for endoscopic retrograde cholangiopancreatography (ERCP) forsuspected choledocholithiasis were prospectively evaluated in a blindedfashion. All were stratified into risk groups using predefined criteria. Endo-scopic ultrasonography (EUS) and ERCP were sequentially performed by two endoscopists.
 Results
: The success rates of EUS and ERCP were 98% and 94%, respec-tively. The accuracy of EUS for diagnosing choledocholithiasis was 94%.EUS provided an additional or alternative diagnosis to bile duct stones in21% of patients. The complication rate of EUS was significantly lower thandiagnostic ERCP. An EUS-based strategy costs less than diagnostic ERCPin patients with low, moderate, or intermediate risk.
Conclusions
: EUS is comparably accurate, but safer and less costly thanERCP for evaluating patients with suspected choledocholithiasis. It is usefulin patients with an increased risk of having common bile duct stones basedon clinical criteria and those with contraindications for or prior unsuccessfulERCP. EUS may enable selective performance of ERCP and improve thecost-effectiveness of diagnosing choledocholithiasis. (Gastrointest Endosc1998;47:439-48.)
 Approximately 10% to 15% of adult Americans orroughly more than 20 million people have gall-stones.
1
Choledocholithiasis may complicate symp-tomatic gallstone disease in 3% to 14% of patientsundergoing cholecystectomy.
2-6
In patients olderthan 60 years, bile duct stones may be present in15% to 60% of cases.
1
Despite its common occurrenceand associated morbidity, the optimal approach todiagnosing and treating choledocholithiasis remainscontroversial. The inconsistent availability of exper-tise in endoscopic stone extraction and laparoscopiccommon bile duct exploration underscores the prob-lematic nature of clearing the extrahepatic bile ductof stones in this era of laparoscopic cholecystectomy.Endoscopic ultrasonography (EUS) combines en-doscopy with real-time, high-resolution ultrasound.Unlike transabdominal ultrasonography (US), itprovides excellent sonographic visualization of theextrahepatic biliary tree without interference of bowel gas. The use of EUS to image the extrahepaticbile duct is relatively novel, but accumulating dataindicate a potential utility for EUS in the perioper-ative evaluation of patients with suspectedcholedocholithiasis.
7-11
EUS is superior to US andcomputed tomography (CT) for diagnosing bile ductstones.
12
To compare the accuracy, diagnostic yield, andsafety of EUS with cholangiography for evaluating patients with suspected choledocholithiasis, we per-formed a prospective, sequential, controlled, blinded
 Received July 3, 1997. For revision October 19, 1997. Accepted January 18, 1998. From the Departments of Medicine (Gastroenterology) and Sur- gery, University Hospitals of Cleveland–Case Western ReserveUniversity, Cleveland, Ohio. Supported, in part, by the Olympus-American Society for Gastro-intestinal Endoscopy Advanced Endoscopy Scholarship. Reprint requests: Marcia Irene Canto, MD, MHS, The Johns Hopkins Hospital, Division of Gastroenterology and Hepatology, Blalock 943, 600 N. Wolfe St., Baltimore, MD 21287-4461.Copyright © 1998 by the American Society for Gastrointestinal Endoscopy0016-5107/98/$5.00
ϩ
0
37/1/88885439
VOLUME 47, NO. 6, 1998 GASTROINTESTINAL ENDOSCOP
 
study comparing the results of EUS and endoscopicretrograde cholangiopancreatography (ERCP). Wealso compared the relative cost of EUS- and ERCP-based strategies for evaluating and treating chole-docholithiasis in defined patient risk groups.
PATIENTS AND METHODSPatients
This study was conducted between January and Decem-ber 1994. Patients were considered for inclusion in thestudy if they had a history of gallstones and were referredfor ERCP for suspected choledocholithiasis based on twoor more of the following: (1) right upper quadrant orepigastric pain; (2) abnormal serum alanine aminotrans-ferase (ALT), aspartate aminotransferase (AST), and/orserum alkaline phosphatase, and/or total bilirubin; (3)history of acute pancreatitis; (4) recent or current acutecholangitis; (5) biliary dilatation on transabdominal US orCT; and/or (6) choledocholithiasis diagnosed by US, CT, orERCP previously performed at another institution. Onlyhemodynamically unstable patients were excluded. Sev-enty patients met these criteria. Of these, 6 declinedparticipation in the study and a total of 64 patients wereenrolled. All participating patients gave informed consentin writing, as approved by our hospital institutional re- view board.
Risk Stratification and Diagnosis ofCholedocholithiasis
 All patients underwent US and/or CT before studyentry. Ten patients had undergone one or more ERCPs atother hospitals before referral. At study entry, clinical andbiochemical data and results of US, CT, or previous ERCP,if applicable, were used to stratify patients into four riskgroups for the likelihood of the presence of choledocholi-thiasis based on a modification of previously publishedcriteria
2
(Fig. 1). “High risk” patients had to have a bileduct stone diagnosed by US or CT or at least three of thefive clinical criteria listed.One of two experienced endosonographers indepen-dently performed EUS at 7.5 MHz with commerciallyavailable 360-degree, sector-scanning ultrasonic endo-scope (Olympus EU-M20; Olympus America, Inc.,Melville, N.Y.) without knowledge of the clinical history,laboratory data, or radiologic imaging results. After topi-cal pharyngeal anesthesia and intravenous conscious se-dation, endosonography was performed using the water-filled balloon method of acoustic coupling. EUS wasperformed primarily in the left lateral decubitus position,but some patients were moved to the prone position whenfluoroscopy was used to ascertain the position of theultrasound transducer. The endosonographer examinedthe main duodenal papilla, head of the pancreas, andextrahepatic bile duct. All ultrasonic images were contin-uously recorded on videotape for documentation andreview.The endosonographer diagnosed choledocholithiasis if there was a reproducible hyperechoic focus within theextrahepatic bile duct with associated acoustic shadowing.The number, location, and size of all stones seen wererecorded. Any abnormalities in the pancreaticobiliary sys-tem were noted, and any malignant-appearing masseswere staged by determining the depth of invasion andpresence of lymph nodes. The quality of the EUS imagewas rated on a three-point ordinal scale (excellent, good,poor) based on image resolution and complete visualiza-tion of the extrahepatic bile duct. Diagnostic certainty of the presence or absence of choledocholithiasis at EUS wasrated on a three-point scale (very certain, moderatelycertain, and uncertain/indeterminate).One of three experienced biliary endoscopists per-formed ERCP immediately after EUS using standardadult video duodenoscopes (JF100, JF130, TJF100; Olym-pus America). The endoscopist was blinded to the resultsof the EUS. Unlike the endosonographer, the endoscopistwas aware of the clinical history and results of US, CT, orprior attempted ERCP. The endoscopist diagnosed chole-docholithiasis if there were one or more filling defectsnoted during bile duct opacification that were not believedto be due to air bubbles. The number and size of filling defects and number of stones extracted after sphincterot-omy were recorded. The presence of bile duct dilatationand other ampullary, pancreatic, and biliary abnormali-ties were noted as well. The quality of the cholangiogramand certainty of diagnosis of the presence or absence of bile duct stones were rated on the same ordinal scale usedfor EUS.
Figure 1.
Stratification of patients into risk groups basedon predefined clinical, biochemical, and radiographic crite-ria.
Fever 
, Body temperature
Ն
38° C;
TBILI
, total bilirubin;
 AP
, serum alkaline phosphatase;
ALT 
, serum alanine ami-notransferase.
 M Canto, A Chak, T Stellato, et al. EUS vs ERCP for diagnosis of choledocholithiasis
440
GASTROINTESTINAL ENDOSCOPY VOLUME 47, NO. 6, 1998
 
If ERCP was unsuccessful in a precholecystectomypatient, EUS results were compared with intraoperativecholangiography. If ERCP was not successful in a post-cholecystectomy patient, ERCP was repeated or the pa-tient was followed to January 1996. A final diagnosis of choledocholithiasis was made if stones were removed from the bile duct by perioperativeendoscopic sphincterotomy or intraoperative stone extrac-tion. The absence of choledocholithiasis was confirmed if no stones were seen in patients undergoing ERCP and/orintraoperative cholangiography, another diagnosis wasmade, or there was no relapse of symptoms and cholesta-sis during a minimum follow-up of 12 months. All minorandmajorpost-procedurecomplications(i.e.,allundesiredoutcomes) of both diagnostic and therapeutic ERCP werenoted, including those that did not require hospitalization.
Cost Identification
Becausepatientsenrolledinthestudywerenotactuallycharged for the EUS, the cost analysis is based on costestimates and not actual costs. However, using the actualoutcomes of each diagnostic test, the relative direct costsof evaluating and treating patients with suspected chole-docholithiasis using EUS- and ERCP-based strategieswere identified and compared after stratifying by riskgroup. The former strategy used EUS as a diagnostic testfollowed by endoscopic sphincterotomy and stone extrac-tion at ERCP only if stones were found at EUS. TheERCP-based strategy used ERCP as both a diagnostic andtherapeutic modality.The cost analysis was based on the existing approach tothe management of bile duct stones at our institution. Inprecholecystectomy patients, intraoperative cholangiogra-phy was not routinely performed at laparoscopic cholecys-tectomy. Expertise in therapeutic ERCP was available atour institution; hence, bile duct stones identified preoper-atively were preferentially extracted at ERCP. If ERCPwas unsuccessful and multiple/large/proximal stones wereidentified by EUS and/or cholangiography, open commonbile duct exploration was performed. Bile duct stonesdiagnosed by intraoperative cholangiography were prefer-entially removed by ERCP after laparoscopic cholecystec-tomy. In post-cholecystectomy patients, ERCP was reat-tempted at least once if the initial procedure wasunsuccessful.The direct costs associated with each type of diagnosticapproach were calculated from the perspective of thethird-party payer. Hospital charges and professional feesdo not necessarily reflect the cost to the payer in Ohio.Hence, 1994 Medicare reimbursement figures for perti-nent CPT codes for outpatient procedures were used(instead of charges) for the cost analysis. These wereobtained from the University Hospitals of Cleveland andthe faculty practice billing offices (University Physicians,Incorporated). The total hospital facility and professionalreimbursement for EUS (CPT 43259 and 76975), diagnos-tic ERCP (CPT 43260), endoscopic sphincterotomy (CPT43262), and stone extraction (CPT 43264) were used in thecost analysis. The radiology costs related to ERCP (use of fluoroscopy and radiology technicians) were not includedbecause all ERCPs were performed in the Digestive Dis-ease Center’s fluoroscopy room without a technician. Thecost of diagnosis, treatment, and hospitalization forprocedure-related complications were also included, if applicable.In the cost analysis, the cost of an additional ERCP wasadded to the cost of an EUS if the latter was unsuccessful(n
ϭ
1), falsely negative or positive (n
ϭ
4), or haduncertain/indeterminate results (i.e., endosonographerunsure about the presence or absence of a bile duct stone,n
ϭ
6). The cost of another diagnostic ERCP was includedin the cost of an ERCP-based strategy if the initial ERCPwas unsuccessful (n
ϭ
4) or falsely positive or negative(n
ϭ
2). The cost of endoscopic sphincterotomy was addedto the cost of an ERCP-based strategy when it wasactually performed because of diagnostic uncertainty (n
ϭ
5) or a false-positive diagnosis (n
ϭ
1). The total andaverage costs of an EUS- and ERCP-based strategy of managing choledocholithiasis were computed. Averagecost was defined as the total cost of performing a diagnos-tic strategy divided by the total number of patients stud-ied. The marginal cost or the difference between each typeof diagnostic strategy was calculated for each risk groupand compared.
Statistical Analysis
McNemar’s test was used to compare paired categoricaldata.
13
Spearman’s rank correlation was used to deter-mine the degree of agreement in EUS and ERCP stonesize.
14
Kappa scores were calculated to determine theconcordance between EUS and ERCP results.
15
Continu-ous paired data (such as the estimated total and marginalcosts) were analyzed using nonparametric methods, in-cluding the Wilcoxon rank-sum test.
16
 A 
p
value of 0.05was considered significant. All statistical analyses wereperformed using SAS 6.10 (SAS PC for Windows; SASInstitute, Inc., Cary, N.C.).
RESULTS
We studied 64 patients; 42 were women and 56%were awaiting cholecystectomy. The mean age was53 years (range 22 to 92 years). All patients under-went both EUS and ERCP. Seventy seven percent of pre-cholecystectomy patients also had intraopera-tive cholangiography. The overall prevalence of cho-ledocholithiasis by stone extraction at ERCP orcholecystectomy was 31%. The distribution of pa-tients into risk groups is given in Table 1. Asexpected, the actual prevalence of bile duct stoneswas significantly different among the risk groups(
 p
ϭ
0.001, Fisher’s exact test). Seventy percent of high-risk patients had bile duct stones comparedwith only 28% of moderate risk, none of the low risk,and4%ofindeterminateriskpatients.USand/orCTdiagnosed only 36% of high-risk patients with cho-ledocholithiasis and none of the moderate and inde-terminate risk patients with stones.
 EUS vs ERCP for diagnosis of choledocholithiasis M Canto, A Chak, T Stellato, et al.
441
VOLUME 47, NO. 6, 1998 GASTROINTESTINAL ENDOSCOP

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