eus with eus-guided fine-needle aspiration

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EUS with EUS-guided fine-needle aspiration as the firstendoscopic test for the evaluation of obstructive jaundice

Richard A. Erickson, MD, Aldo A. Garza, MD

Temple, Texas

Background: This study assesses the cost savings associated with using endoscopic ultrasound(EUS) before endoscopic retrograde cholangiopancreatography (ERCP) for evaluating patientswith suspected obstructive jaundice.Methods: One hundred forty-seven patients with obstructive jaundice of unknown or possiblyneoplastic origin had EUS as their first endoscopic procedure. With knowledge of the final diag-nosis and actual management for each patient, their probable evaluation and outcomes and theiradditional costs were reassessed assuming that ERCP would have been performed as the firstendoscopic procedure. Also calculated were the additional costs incurred if EUS were unavailablefor use after ERCP and had to be replaced by computed tomography or other procedures.Results: The final diagnoses in these patients included malignancies (65%), choledocholithiasisor cholecystitis (18%),medical jaundice (11%), and miscellaneous benign conditions (6%). Fifty-four percent had EUS-guided fine-needle aspiration but only 53% required ERCP after EUS. An

EUS-first approach saved an estimated $1007 to $1313/patient, but the cost was $2200 more if EUSwas unavailable for use after ERCP. Significant savings persisted through sensitivity analysis.Conclusions: Performing EUS with EUS-guided fine-needle aspiration as the first endoscopic pro-cedure in patients suspected to have obstructive jaundice can obviate the need for about 50% ofERCPs, helps direct subsequent therapeutic ERCP, and can substantially reduce costs in thesepatients. (Gastrointest Endosc 2001;53:475-84.)

VOLUME 53, NO. 4, 2001 GASTROINTESTINAL ENDOSCOPY 475

The evaluation of the patient with obstructivejaundice is a common clinical problem. Most algo-rithms for evaluating these patients1-3 recommendclinical and laboratory assessment first, then confir-mation of extrahepatic obstruction by using a non-invasive imaging method such as transcutaneous

abdominal ultrasound (TUS), CT, or more recentlymagnetic resonance imaging or magnetic resonancecholangiopancreatography (MRCP). If these studiessupport a diagnosis of extrahepatic obstruction or ifthe clinical suspicion for obstruction is still highdespite a nonsupportive result of TUS, CT, or MRCP,then ERCP is usually recommended to definitivelyimage the biliary tree, obtain a tissue diagnosis if aneoplasm is suspected, and provide therapy for theunderlying disorder if appropriate.

EUS can likewise diagnose most of the causes ofobstructive jaundice such as pancreaticobiliary malig-nancies4-7 and choledocholithiasis8-10 with the sameor better accuracy than ERCP. With the more recentintroduction of EUS-guided fine-needle aspiration(EUS-FNA),11-13 EUS can now provide a tissue diag-

nosis of underlying pancreaticobiliary malignancywith higher success rates than ERCP.11-17 In addition,EUS provides important staging information for pan-creaticobiliary malignancies,18,19 which is difficult toobtain by ERCP.20,21 EUS and EUS-FNA do not carrythe significant level of risk of pancreatitis or cholangi-tis of ERCP,22 and they do not mandate biliary stentplacement in obstructed patients as does ERCP.22,23

The diagnostic capabilities and lower morbidityof EUS have led us24 and others25,26 to propose thatthe ideal endoscopic approach to obstructive jaun-dice may be the combination of EUS/EUS-FNA fol-lowed by ERCP if necessary for therapy or to obtainfurther diagnostic information. The purpose of thisstudy was to quantitate the impact on the subse-quent need for diagnostic or therapeutic ERCP andto estimate the change in costs associated withusing EUS/EUS-FNA before ERCP in patients withsuspected obstructive jaundice.

METHODS

Two hundred sixteen consecutive adult patients werereferred for evaluation of probable obstructive jaundice

Received April 25, 2000. For revision July 31, 2000. Accepted

September 22, 2000.From the Departments of Medicine, Scott & White Hospital andClinic, Texas A&M Health Science Center, College of Medicine,Temple, Texas.

Presented in part at the American College of Gastroenterologymeeting, October 1999, Phoenix, Arizona, and at the EUS 2000International Symposium, February 2000, Monte Carlo.

Reprint requests: Richard A. Erickson, MD, GastroenterologyDivision, Scott & White, 2401 S. 31st St., Temple, TX 76508.

Copyright 2001 by the American Society for GastrointestinalEndoscopy 0016-5107/2001/$35.00 + 0 37/1/111772

doi:10.1067/mge.2001.111772


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between June 1995 and March 2000. Patients were man-aged according to the basic algorithm outlined in Figure 1.The aim of this algorithm was to optimize endoscopic eval-

uation by placing the diagnostically more powerful proce-dures EUS/EUS-FNA before ERCP in those patients inwhom a pancreaticobiliary malignancy was clinically a sig-nificant possibility1,2 and thus EUS/EUS-FNA would ulti-mately be performed in any case. In addition, EUS wasused first in those patients in whom it was thought clini-cally that the likelihood of needing a therapeutic ERCPwas not high and would therefore be better served by EUS,a test with a lower morbidity. This algorithm is similar tothat recently published by Dancygier and Lightdale.26

Patients with probable obstructive jaundice weredefined as those with a total bilirubin of 3 mg% or greater(51 mol/L) and a clinical history, physical examinationand laboratory evaluation suggesting extrahepaticobstruction.1,2 Usually these patients were then evaluat-ed by either TUS or CT (usually spiral) (MRCP was usedin only 1 patient). EUS/EUS-FNA was used as the firstendoscopic study in jaundiced patients unless one of thefollowing clinical situations existed for which ERCP wasconsidered more appropriate: (1) high likelihood (greaterthan 50%) of choledocholithiasis by clinical or radiologicevaluation27 (35 patients); (2) suspected bacterial cholan-gitis (1 patient); (3) jaundice that by clinical evaluation orabdominal imaging appeared to be due to a previouslydiagnosed malignancy or where tissue diagnosis wasthought to be clinically unnecessary (20 patients); (4) pre-viously diagnosed benign cause for obstructive jaundice (3patients); (5) known Billroth II anatomy (2 patients); (6)suspected sclerosing cholangitis (1 patient); (7) EUS wasunavailable (1 patient); (8) the attending gastroenterolo-gist preferred ERCP first (6 patients).

A total of 69 of the 216 patients (32%) had ERCP firstbecause of one of the above clinical situations. This left147 consecutive patients with obstructive jaundice whohad EUS as the first endoscopic procedure. Includedamong these 147 patients were 6 in whom ERCP wasattempted first but was unsuccessful in terms of diagnos-tic information. Thus, these 6 patients were included inthe analysis of the EUS-first approach.

Diagnostic EUS and any subsequent EUS-guided FNAwere performed by one endosonographer (R.A.E.), as pre-viously described13,28 by using sector scanning echoendo-scopes (UM20, UM130; Olympus America, Inc., Melville,N.Y.). If a pancreaticobiliary neoplasm was detected, itwas staged with radial endosonography. EUS-guided FNAwas done using the linear array echoendoscopes (FG-

32UA, FG-36UX or FG-3631U; Pentax PrecisionInstrument Corp., Orangeburg, N.Y.) with either theMediglobe (GIP-Medi-Globe, Grassau, Germany) or theEchoTip (Wilson-Cook Medical Inc., Winston-Salem, N.C.)22-gauge aspiration needles.A cytopathologist was alwayspresent during the EUS-guided FNA.13,28,29All patientsgave informed consent for EUS and possible EUS-FNAand/or diagnostic or therapeutic ERCP under the samesedation depending on the findings of the initialEUS/EUS-FNA. Patients with obstructive jaundice under-going EUS alone and/or EUS-FNA were not given antibi-otics prophylactically.11

If ERCP was believed to be indicated after EUS, it wasperformed, usually while the patient was still sedated and

by the same endoscopist. Stents were occasionally placedon a day other than that of the EUS if on subsequent eval-uation the patient was not believed to be an operative can-didate or a significant delay before surgery was anticipat-ed because of schedule, preoperative evaluation or the useof neoadjuvant chemoradiation. If a stent was placed, ametallic stent was used in patients with an estimated sur-vival of greater than 6 months as judged by a combinationof tumor size, the presence of metastatic disease and per-formance status and comorbidities.30-32 For the purpose ofthis analysis, a stent placed more than 90 days after theinitial EUS was not counted as a post-EUS ERCP.

Each patients clinical course, including the results ofsubsequent diagnostic or therapeutic tests, was prospec-tively followed and pertinent data were entered into anelectronic EUS database up to the point of definitive diag-nosis and therapy. Survival data for patients with malig-nancies were also collected for our institutional tumor reg-istry. Once the final outcome and therapy of the patientwere known, the course of each patients evaluation wasreassessed with an assumption that instead of EUS, ERCPhad been the first endoscopic procedure performed. Theprobable findings on ERCP and the patients subsequentevaluation were reassessed by using information gatheredeither from actual findings on an ERCP subsequent toEUS or from the probable ERCP findings given the knowndiagnosis made by EUS and/or other evaluations.

The following assumptions were made, based on pub-lished information and our experience with ERCP forobstructive jaundice, as to how ERCP would have beenused in these patients with obstructive jaundice if per-formed as the first endoscopic procedure:

1. If the patient was found to have a biliary stricture atERCP, a plastic stent would be placed to minimize therisk of ERCP-induced cholangitis.22,23,33

2. If a malignant-appearing stricture of the bile duct orpancreatic duct was seen by ERCP, an attempt at cyto-logic or tissue diagnosis by brush cytology, transpapil-

R Erickson, A Garza EUS/EUS-guided FNA for obstructive jaundice

476 GASTROINTESTINAL ENDOSCOPY VOLUME 53, NO. 4, 2001

Figure 1. Algorithm used in this study for managing patientswith suspected obstructive jaundice.


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lary FNA and/or biopsy3,14-17 would be made. If thedefinitive diagnostic tissue yields from ERCP assess-ment of malignant pancreaticobiliary strictures wereassumed to be greater than 40% for the sensitivityanalysis of our study, then ERCP with brush cytology,FNA and duct biopsy17 along with their attendant

additional costs would all have to be used.3. If a stent was placed for malignancy, a plastic stent would

be placed initially and changed by ERCP at a later dateto a metallic stent if subsequent evaluation showed thepatient to not be an operative candidate and to have apotential survival of more than 6 months.30-32

4. As per the policy of Medicare34 and most insuringagencies, the professional charges for EUS done on thesame day as ERCP would be reduced by 50%.

5. Although most authorities recommend that antibiotics begiven intravenously as a prophylactic measure when per-forming therapeutic ERCP in obstructed patients,3,23,35

this approach is controversial.36 In addition, antibiotics

given orally may be as efficacious as intravenously.37 Inour institution combinations are used of intravenousciprofloxacin or cephtriaxone and/or oral ciprofloxacinselectively depending on the perceived risk of infectionand adequacy of biliary drainage.Therefore only $50 wasadded per the cost of ERCP to cover the average cost ofprophylactic antibiotics.

6. If a malignant-appearing stricture was found by ERCP,an EUS, if available, would be done within a day tohelp stage the lesion and to make a cytologic diagnosisby EUS-FNA if the definitive cytologic or tissue diag-

nosis of malignancy was not made at ERCP and/or theprior CT did not yield enough information to stage thepatient as inoperable.

7. In order not to overestimate the impact of EUS, theassumption was made that the failure rate for ERCPwas zero, even though in most series failure rates runbetween 1% and 15%.38

8. EUS/EUS-FNA would not be done on the same dayafter an ERCP because it would be unreasonable to useanother biopsy technique (EUS-FNA) until the resultsof the samples taken at ERCP were available (usuallythe next afternoon).

By using a spread sheet based cost analysis previouslydescribed,39 the difference in estimated costs of evaluat-ing the patients by using EUS first (their actual manage-ment) was compared with the probable management ifthey had been evaluated with ERCP first. Incorporatedinto this analysis were variables such as actual fee-for-service and regional Medicare charges for each procedure,the estimated cost per hospital day, the percentage ofjaundiced patients managed as inpatients versus outpa-tients, publication-derived complication rates for ERCP,post-therapeutic ERCP hospitalization rates and the fre-quency of a definitive tissue diagnosis by EUS-FNA andERCP (Table 1).

The relative true cost of EUS and ERCP is difficult toderive and is the subject of a recent multicenter study.44

Fully recognizing that procedure charges and costs arenot the same thing, our institutions fee-for-service andMedicare procedure charges were used as the most rea-

EUS/EUS-guided FNA for obstructive jaundice R Erickson, A Garza


Table 1. Medicare and fee-for-service total procedure charges (professional and technical charges andsupplies) and miscellaneous costs and values used in cost analysis

Procedure Medicare charges Fee-for-service charges

Diagnostic EUS $822 $1873EUS-FNA $1542 $3481Diagnostic CT $350 $1143

CT-FNA-pancreas $909 $1956Diagnostic ERCP $930 $1704ERCP with sphincterotomy and stone extraction $1132 $2757ERCP with plastic stent, no brush cytology $1056 $2418ERCP with plastic stent and brush cytology $1298 $2796ERCP with plastic stent and brush cytology, FNA and biopsy $1440 $3244ERCP with metallic stent, no brush cytology $2063 $3425Upper endoscopy for stent removal $427 $1149

Range used for

Other values used in cost analysis sensitivity analysis

Cost for therapeutic ERCP complication40 $4000 $1-10,000Cost of a day of hospitalization39 $800 $300-1500Cost of a significant delay in diagnosis of unsuspected acute cholecystitis41 $5000 $2-10,000Cost of major abdominal operation39,40,42 $20,000 $5-40,000

Yield of positive diagnosis after ERCP sampling of malignant biliary stricture3,14-17

40% 20%-80%Cost factor for underrepresentation of EUS charges to true cost 1.0 1.0-2.6of EUS relative to ERCP

Yield of positive cytologic diagnosis after EUS-FNA 96% 50%-100%Hospitalization rate after planned outpatient therapeutic ERCP43 15% 5%-75%% of jaundiced patients who are inpatients 33% 0-100%Post-therapeutic ERCP major complications22 5.0% 2%-10%


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sonable range estimates for true procedural costs and therelative cost ratio of one procedure to another. To accountfor the possibility that the charges for EUS relative toERCP may underrepresent the true costs of EUS relativeto ERCP, the impact of selectively increasing the chargesfor EUS/EUS-FNA relative to ERCP was examined in thesensitivity analysis.

The cost analysis also included the estimated cost of adelayed diagnosis of a life-threatening disease (4 patientswith unsuspected acute cholecystitis and 1 with an unsus-pected pancreatic carcinoma) found on EUS that wouldnot have been detected by ERCP and had not been recog-nized by prior diagnostic procedures. To examine the costsassociated with unavailability of EUS/EUS-FNA forpatients with obstructive jaundice, the analysis was alsorun assuming that EUS was unavailable and would haveto be replaced by TUS or CT-guided FNA or, if the lesionwas not evident at TUS or CT, by other investigationssuch as diagnostic laparotomy. Sensitivity analysis of theresults of the cost analysis was done by varying the valuesin Table 1 through reasonable ranges, individually and in

combination, as supported by the published data and/orclinical experience.42,43

RESULTSActual patient management

The final diagnoses in the 147 patients are sum-marized in Table 2. Sixty-two percent of the patientswere men and the average age was 69.4 years with arange of 26 to 91 years. Ninety-six of these patients(65%) had malignancy as the cause of jaundice. Twothirds of these were pancreatic cancers with the rest

fairly equally divided between metastatic disease,papillary and biliary (bile duct and gallbladder) can-cers. Of the benign causes of obstructive jaundice, 26patients (18%) had choledocholithiasis or cholecysti-tis, 9 (6%) had miscellaneous benign conditions and16 (11%) had no evidence of biliary obstruction, thatis, medical jaundice. One patient had obstructive

jaundice caused by a common duct stone but also hada clinically unsuspected carcinoma found in the neckof the pancreas.

EUS was successful in all 147 patients. Eighty(54%) of the patients had EUS-FNA as part of theirEUS evaluation. EUS-FNA provided a positive cyto-logic diagnosis of malignancy in 74 of the 77 patients(96%) who underwent the procedure and eventuallyhad the diagnosis of underlying neoplasm confirmed.The average number of EUS-guided FNA passes forthe 55 pancreatic masses was 3.40 2.20 (SD) (range1 to 10), for 17 lymph nodes 1.53 0.51 (range 1 to 2)and for 13 other masses and 4 liver metastases 2.94 2.05 (range 1 to 10).

There were 2 cardiorespiratory complications inthe 147 patients undergoing EUS/EUS-FNA. One88-year-old man with severe congestive heart fail-ure and jaundice was admitted for 2 days after EUSbecause of a prolonged recovery from sedation.

Another patient was hospitalized for 1 day afterdeveloping sudden hypoxia in the recovery room,which spontaneously cleared after a few minutesand was later attributed to mucous plugging.



Table 2. Final diagnoses and actual procedures performed in 147 patients undergoing EUS first for sus-pected obstructive jaundice

EUS-FNA site ERCP after EUS Surgical therapy

Plastic Metallic

Diagnosis No. Mass Node Liver Failed Diagnostic ES stent stent Resection Bypass

Malignant obstructionPancreatic carcinoma 63 54 3 4* 3 (2) 2 (1) 17 (10) 10 (2) 25 12Cholangiocarcinoma 9 5* 2 1 4 (2) 4 (2) 1 5Gallbladder carcinoma 5 5 2 3 (1)

Ampullary carcinoma 10 1 6 1Metastatic disease 9 2 2 1* 2 3 1

Choledocholithiasis 18 1 1 (1) 16 (3) 1Cholecystitis 8 1

Miscellaneous benign lesions 9 3 3 2 2 (2) 1 1No biliary obstruction detected 16 4 (1)

Total 147 70 7 6 3 (2) 17 (5) 18 (3) 29 (11) 16 (3) 37 1580

Numbers in parentheses designate the total number of ERCPs done on a separate day from the EUS/EUS-FNA.ES, Endoscopic sphincterotomy.*EUS-FNA also positive in an aspirated lymph node(s) in this patient.

Includes unknown primary (3), lymphoma (2) and 1 each of breast, renal, gastric and multiple myeloma.Includes 1 patient also found to have an unsuspected pancreatic carcinoma.Confirmatory diagnostic ERCPs done within the first 18 months of the study. Each symbol denotes an individual patient. None of

these ERCPs demonstrated new findings. Includes chronic pancreatitis (3), choledochocele (2), and 1 each of postoperative stricture, acquired immune deficiency syndrome

cholangiopathy, peribiliary fibrosis and biloma.


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There was 1 patient (0.7%) misdiagnosed by theEUS-first approach.This 46-year-old man was foundon EUS to have chronic pancreatitis with a distalbiliary stricture and a proximal bile duct stone withechogenic biliary sludge but no definite pancreaticmass. At ERCP, the stone could not be removed

because of the stricture. Brush cytology of the stric-ture at ERCP was also negative. The patient wasbelieved to have either chronic pancreatitis or asmall pancreaticobiliary malignancy and underwentcholedochojejunostomy after transduodenal intraop-erative biopsies of the strictured area were inter-preted as benign. However, the patient representedwith metastatic pancreatic carcinoma 10 monthslater.

The actual procedures performed in these 147patients are also shown in Table 2. One third (48) ofthe patients were inpatients at the time of evalua-tion. Eighty-three (56%) of the patients had an

ERCP within 90 days of the EUS. Five of theseERCPs were confirmatory and were done during thefirst 18 months of our institutions experience withEUS. None of these confirmatory ERCPs demon-strated additional findings. This left 78 patients(53%) who underwent ERCP as an aid to diagnosisor therapy. Other than providing endoscopic thera-py, additional useful diagnostic information was pro-

vided by ERCP in 14 (17%) of the patients whounderwent ERCP after EUS. However, the informa-tion provided by ERCP was clearly superior to thatprovided by EUS in only 2 of these 14 patients. In 1patient, ERCP demonstrated a small Klatskins

tumor not seen by EUS, although hilar level of ob-struction was evident. ERCP brush cytology of thislesion suggested but was not diagnostic of malig-nancy; this was confirmed at resection. Unbeknownto the endosonographer, another patient had hadsphincterotomy and when EUS was performed, airwithin the biliary tree prevented adequate exami-nation of the porta hepatis. Subsequent ERCPdemonstrated this region. The EUS findings wereclearly superior to those of ERCP in 20 patients (4because the prior ERCP was unsuccessful); EUSand ERCP revealed similar biliary findings in 51patients.

Because major therapeutic decisions are based onEUS staging, the accuracy of this information mustbe considered in an EUS-first approach. In a previ-ous study of our surgically confirmed TNM stagingaccuracy for pancreatic cancer45 our T stage accura-cy was 88% and N stage accuracy was 64%, similarto that reported by others.18,19,46,47 However,patients considered to have unresectable tumors inthe current study based primarily on EUS criteriadid not undergo surgery to verify the accuracy of

staging. Survival was substituted for staging accu-racy in this group of patients. If these patients trulyhad a more advanced stage of disease, survivalshould be similar to that reported for patients withsurgically unresectable pancreatic cancer. Of the 64patients with pancreatic cancer in this study, 37 had

operations (25 resections and 12 bypasses) whereoperability could be assessed surgically. Fourpatients had metastatic liver disease confirmed byEUS-guided FNA. Four patients had resectabletumors by EUS but were deemed inoperablebecause of major comorbidities or extreme age. Thisleft 19 patients who were considered by EUS crite-ria (i.e., substantial major vessel invasion) to haveunresectable tumors. The median survival of these19 patients was 158 days (range 11 to 283 days),which is the same as that previously reported forpatients with unresectable pancreatic cancer: 6months,31 5 months,48 and 5 months.49

Cost analysis

The procedures that probably would have beendone in these 147 patients if ERCP were to be thefirst endoscopic procedure are detailed in Table 3.The primary change with respect to the types andnumbers of procedures done with an ERCP-firststrategy relate to the use of more than 80 ERCPsthan with the EUS-first approach. Because of theinformation provided including that by tissue diag-nosis at ERCP, the estimated number of EUS orEUS-FNAs needed with an ERCP-first approachwould be reduced by 20 and 31, respectively.

However, because the yield of an unequivocally pos-itive brush cytology, FNA or biopsy at ERCP for apancreaticobiliary malignancy is generally low,14-17

a significant number of post-ERCP procedures toobtain a tissue diagnosis would still be required,either EUS-FNA, CT-FNA, or occasionally explora-tory laparotomy if the lesion was not evident on spi-ral CT and EUS-FNA was not available.

The estimated additional cost associated with theERCP-first approach to obstructive jaundice withthe assumptions of our standard analysis are shownin Table 3. Overall, an additional $1007 would bespent per patient if Medicare charges are used forprocedural costs or $1313 if fee-for-service chargesare used. If EUS or EUS-FNA were not availableafter ERCP and CT-FNA or laparotomy had to beused to obtain a tissue diagnosis, then the extra costper patient increases significantly to $2139 and$2229, respectively (Table 4).

Sensitivity analysis

The impact of varying the assumptions and vari-able parameters in the cost analysis (sensitivity




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Table 3. Actual procedures performed in 147 patients having EUS first for obstructive jaundice comparedwith probable procedures that would be done if an ERCP-first approach was used and the estimated costsavings with an EUS-first approach with the values of our standard analysis and Medicare and fee-for-service procedure costs in Table 2

Actual Probable Estimated cost savings

procedures procedures for EUS-first

EUS-first ERCP-first* Difference Medicare Fee-for-service

Diagnostic EUS 67 47 (20) ($16,594) ($37,836)EUS-FNA 80 49 (31) ($47,493) ($107,205)Diagnostic ERCP 20 37 17 $15,804 $28,970Therapeutic ERCP

ERCP with endoscopic sphincterotomy 18 18 0 0 0ERCP with plastic stent placement, no cytology 27 3 (24) ($25,229) ($57,744)ERCP with plastic stent and brush cytology 2 89 87 $112,771 $242,924ERCP with metallic stent placement 16 17 1 $2063 $3425

Endoscopy to remove a stent 0 2 2 $853 $2298Additional inpatient days to complete evaluation 0 43 43 $34,165 $34,165

using ERCP-first approachCalculated post-ERCP major complications 4.2 8.2 4 $16,200 $16,200Calculated inpatient observation days after 8.4 16.6 8.3 $6551 $6551

outpatient ERCPNondiagnostic EUS-FNA requiring another biopsy 2 2 $44 $94

technique if ERCP biopsy also negativeDelayed or missed diagnoses of a major morbid 0 5 5 $25,000 $25,000

condition with ERCP-first (4 acute cholecystitis,1 pancreatic carcinoma)

50% reduction of professional charges only for 59 EUS $23,864 $36,096done on same day as ERCP plus 19.2 inpatientdays saved for same day EUS and ERCP

Total $148,000 $192,938Divided by 147 patients $1007/patient $1,313/patient

Additional major diagnostic operations with 0 12 12ERCP-first if EUS/EUS-FNA not available

*In the actual cost analysis some of these values are calculated numbers and therefore may be fractions of whole numbers. For sim-plicity in the table they are displayed rounded to the nearest integer.

Table 4. Estimated additional costs per patient incurred if an ERCP-first approach were to be used forthe 147 patients instead of the EUS-first approach actually used

Additional cost per patient

Medicare Fee-for-service

Standard analysis $1007 $1313Only CT/CT-FNA available $2139 $2229Confirmatory ERCPs not included $1044 $1370ERCP done on separate day from EUS $844 $1067

All patients outpatients versus all inpatients $691/$1659 $997/$19655% versus 75% of patients hospitalized after ERCP $977/$1185 $1283/$1491ERCP complications 2% versus 10% $941/$1117 $1246/$1423Great ERCP, poor EUS (ERCP tissue yield 70%, ERCP complications 2%, $538 $772

post-ERCP hospitalization 5%, 90% outpatients, EUS must be on separate day,EUS-FNA yield only 70%)

With true cost of EUS 1.5 ERCP $259 $144Standard analysis

With malignant diagnoses only (96 patients) $1186 $1792With benign diagnoses only (51 patients) $722 $516With pancreatic cancers only (64 patients) $1072 $1746With resectable pancreatic cancers only (25 patients) $1424 $2221With EUS unresectable pancreatic cancers only (19 patients) $2302 $2348Only CT/CT-FNA available, pancreatic cancers only $3002 $3328

Additional rows show the alterations (sensitivity analysis) in these additional costs per patient when the assumptions or values usedin the analysis are taken to their extremes. Further sensitivity analyses are displayed in Figure 2.


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analysis) are shown in Table 4 and Figure 2. Becauseconfirmatory ERCPs are no longer performed afterEUS at our institution, if the 5 confirmatory diag-nostic ERCPs done in the first 18 months of thisstudy are excluded from the EUS-first costs, the sav-ings associated with performing EUS-first increases

by about $50 per patient. In addition, some of thecost savings of the EUS-first approach derive fromperforming EUS on the same day as ERCP. Thesesavings result primarily from inpatient days savedby a more expeditious evaluation and to a lesserextent from the decrease in professional charges fora same-day procedure. If ERCP had to be performedas a separate procedure on the day after EUS/EUS-FNA, the cost savings per patient of an EUS-firstapproach are reduced by about 20%.

Our sensitivity analysis suggested the cost sav-ings accrued from an EUS-first approach were rela-tively insensitive to wide variations in the percent-

age of major complications occurring as a result ofERCP, the costs attributed to ERCP complications,the cost of a hospital day, or the cost of a delayeddiagnosis or major operation. However, the addition-al costs if EUS/EUS-FNA were unavailable and hadto be replaced by CT/CT-biopsy were significantlydecreased by decreasing the cost of an unneededmajor abdominal operation.

The primary factors that affected the additionalcost per patient of an ERCP-first approach were theinpatient versus outpatient status of the patient,the yield of a positive cytologic or tissue diagnosis byERCP and EUS-FNA, the hospitalization rate after

an outpatient ERCP and the true cost of EUS rela-tive to ERCP. The EUS-first strategy saves evenmore money per hospitalized patient or if the hospi-talization rate after outpatient ERCP is high (Table4). The amount of money saved drops as the yield ofERCP tissue diagnosis increases or the yield ofEUS-FNA decreases (Fig. 2).

Obviously, if EUS/EUS-FNA actually costs sub-stantially more than that estimated by currentMedicare or fee-for-service charges, then the costsavings must be less. However, as shown in Figure2, the relative cost of EUS/EUS-FNA to ERCP mustbe more than doubled in our standard analysis toeffectively eliminate the cost savings of an EUS-firstapproach. Multiple combinations of changes in the

variables used in this analysis were made to deter-mine under which assumptions the cost savingsassociated with an EUS-first approach persist. Ifthese combinations are taken to clinically unrealis-tic extremes, highly favoring ERCP (see GreatERCP, poor EUS in Table 4), then the cost savingsof an EUS-first approach are effectively negated.However, using the values of our standard analysis,

which represents the combination of high qualityERCP and EUS/EUS-FNA, the EUS-first strategyresulted in an estimated overall cost savings ofbetween $150 and $200,000 for the 147 patients inthis study.

When subanalyses of our study population aremade (Table 4) according to the various types ofmalignant obstructive jaundice, an EUS-first strat-egy saves substantially more per patient than wasfound in the overall analysis. Similar to the resultsof a prior study of the cost savings of using

EUS/EUS-FNA in pancreatic cancer,29 if EUS is notused in patients with malignant biliary obstruction,the added cost (primarily because of unnecessaryoperations) is greater than $3000 per patient.

DISCUSSION

Because the procedures developed relatively re-cently, the potential role of EUS and EUS-FNA inthe evaluation of obstructive jaundice is poorlydefined. This study is the first to quantitate actualimpact on the need for subsequent ERCP and toestimate the cost-effectiveness of using EUS/EUS-FNA as the first endoscopic procedure in the inves-tigation of obstructive jaundice.

The use of EUS/EUS-FNA first correctly identi-fied the cause of obstructive jaundice in all but 1patient (also missed by ERCP and operation) andreduced the total number of patients needing ERCPby 47%. Our best estimate of the cost savings of anEUS-first strategy was between $1007 and $1313per patient, and an estimated additional $2200would be spent per patient if EUS/EUS-FNA werenot used at all. Sensitivity analysis suggests that



Figure 2. Sensitivity analysis curves for the standard costanalysis assumptions used in this study while varying the rel-

ative cost of EUS/EUS-FNA to ERCP. Also shown are the

effects on dollars saved with various combinations of

changes in the variables used in the cost analysis (Table 4).

EUS/ERCP cost factor


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the cost savings realized by EUS/EUS-FNA remainssignificant despite varying the assumptions througha wide range of values.

The reasons for the cost savings associated withan EUS-first approach for obstructive jaundice aremultifactorial. (1) The high diagnostic accuracy of

EUS/EUS-FNA (98% in the current study) makesERCP unnecessary in patients found not to haveextrahepatic obstruction or to have a lesion that doesnot require therapeutic ERCP. (2) Patients bestserved by operative biliary drainage (either resectiveor palliative) are reliably identified and therefore donot need ERCP. (3) The high positive yield of EUS-FNA for cytology in malignant obstruction (96% inour study) obviates the need to obtain brush cytology,transductal FNA or ductal biopsy at ERCP, whichhave a disappointingly low yield in most series, espe-cially for pancreatic carcinoma.3,14-17 This low yieldoften results in additional procedures (EUS-FNA,

CT-FNA or operation) to make a tissue diagnosis ofcancer. (4) Patients best served by implantation of ametal expandable stent undergo this procedure attheir first ERCP because a definitive diagnosis,unresectability and prognosis have already beenestablished by EUS and EUS/FNA. (5) For hospital-ized patients (one third of patients in the presentstudy), each extra day in hospital increases costs.Thus the expeditious diagnosis, tissue acquisitionand appropriate therapy afforded by EUS/EUS-FNAresult in substantial savings in terms of hospitaldays. (6) The significantly higher cost of the ERCP-first approach when EUS/EUS-FNA are not avail-

able reflects the cost savings incurred when EUSidentifies patients who are inoperable but would stillundergo surgery when this assessment is madebased on CT information alone.This type of cost sav-ings has been shown previously for EUS/EUS-FNAin pancreatic carcinoma.29

A number of factors could significantly affect thecost savings estimated for an EUS-first approach inthis study. Our yield for a definitive cytologic diag-nosis with EUS-FNA (96%) is among the highestreported11-13 and may not be the norm. The impactof differences in tissue diagnosis yields with EUS-FNA and ERCP was assessed in the sensitivityanalysis. Because pancreatic cancer was present in43% of the patients in our series, the way in whichan institution approaches the management of thisdisease could significantly affect the relative rolesand cost-effectiveness of EUS and ERCP in obstruc-tive jaundice. If an attempt at preoperative tissuediagnosis is not made in patients with potentiallyoperable disease, the advantages relating to the reli-ability of EUS-FNA for cytologic diagnosis decrease.If neoadjuvant therapy is used routinely before

attempting resective surgery for pancreatic carcino-ma,50 then plastic stents would usually be placed inall patients to allow 6 to 12 weeks of preoperativechemoradiation. In most institutions, same day EUSand ERCP may be impracticable because the proce-dures are done by different physicians or the endos-

copy schedules may not permit it. Without same dayEUS and ERCP, the cost savings of an EUS-firstapproach are reduced by about 20% (Table 4). Inaddition, some patients undoubtedly could be dis-charged after biliary stent placement to continueevaluation on an ambulatory basis. This wouldreduce the cost savings in our analysis attributed tothe extra hospital days accrued with an ERCP-firstapproach (Table 3). However, as shown in Table 4,even if all the patients were managed as outpa-tients, the cost savings of an EUS-first approachwould be reduced by only about 30%. Finally,although the attempt is made to expedite pancreati-

coduodenectomy, in most institutions there is likelya significant delay between diagnosis and operation.This may relate to difficulties in scheduling a longoperation or to the time required to complete preop-erative medical and oncologic evaluation or treat-ment. If delays are likely, a patient with biliaryobstruction is better served by biliary stent place-ment rather than have the patient suffer continuedmalaise and pruritus and risk of cholangitis. Indeed,in most of the patients who had stents placed on aday other than EUS in our series (14 of 45 patientsreceiving stents, Table 2) one of the above situationsdeveloped.

Other imaging technologies are also achievingpromising results in the evaluation of pancreatico-biliary diseases such as MRCP and advanced spiralCT. As computer technology increases, these tech-niques will only become more powerful. Thus, theroles of these radiologic procedures in obstructive

jaundice are, like EUS, in a state of evolution.In conclusion, this study is believed to demon-

strate that EUS and EUS-FNA as needed as firstprocedures in patients with suspected obstructive

jaundice due to possible pancreaticobiliary neo-plasm or of unclear origin obviate the need foralmost half of the ERCPs that might otherwise bedone and at considerable cost savings. Therefore,where high quality EUS/EUS-FNA is available,these patients are most efficiently managed by per-forming EUS as the first endoscopic procedure, withEUS-FNA if a possible malignancy is visualized, fol-lowed directly by therapeutic ERCP when indicatedby the findings at EUS/EUS-FNA. EUS/EUS-FNAshould be an integral and early part of the evalua-tion of patients when there is a suspicion of malig-nant obstructive jaundice.




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