Original Article

Initial experience of direct-to-test endoscopic ultrasonography for suspected choledocholithiasis

Scottish Medical Journal 2015, Vol. 60(2) 85–89 ! The Author(s) 2015 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0036933015572276 scm.sagepub.com

Paul Lochhead1 and Perminder Phull2

Abstract Background and aims: Endoscopic ultrasound has become an invaluable tool in the investigation of patients with suspected pancreatobiliary disease. We set out to determine whether a ‘‘direct-to-test’’ endoscopic ultrasound procedure could be offered to selected patients with suspected choledocholithiasis. Methods and results: We included patients referred to our general gastroenterology service with clinical history, symptomatology and/or laboratory results compatible with choledocholithiais. Almost all patients had already had a transabdominal ultrasound performed at the request of their general practitioner. All patients underwent direct-to-test day-case endoscopic ultrasound under conscious sedation. Procedures were performed by a single practitioner using an oblique-viewing radial echoendoscope. The diagnostic yield and frequencies of discharge, onward referral and follow-up were determined. Overall diagnostic yield of direct-to-test endoscopic ultrasound was 61%. The most common diagnoses were cholelithiasis (18%) and choledocholithiasis (11%); one periampullary cancer was also detected. A definitive outcome (discharge or referral for a therapeutic procedure) occurred in 14 of 28 patients (50%). The remaining 14 patients underwent further out-patient evaluation. Eventual diagnoses in this group included autoimmune hepatitis, primary biliary cirrhosis and drug-induced hepatitis. Conclusions: For patients with suspected biliary disease, direct-to-test endoscopic ultrasound has a high diagnostic yield, and may be an appropriate mode of investigation.

Keywords Endosonography, referral and consultation, gallbladder diseases, biliary tract

Introduction Endoscopic ultrasound (EUS) has become an invaluable investigation in the assessment of pancreatobiliary disease.1,2 EUS is superior to transabdominal ultrasound (TUS) in the detection of choledocholithiasis, possessing a high positive predictive value,3,4 comparable with that of magnetic resonance cholangiopancreatography (MRCP).5 Compared to TUS, EUS affords superior visualisation of the pancreas permitting the detection of early neoplastic lesions.6–8 EUS is also a sensitive imaging modality for ampullary lesions.9,10 Unlike MRCP, computed tomography (CT), TUS and EUS with modern echoendoscopes offer the added advantage of direct visualisation of the upper gastrointestinal (GI) mucosa.

In our institution (as, we suspect, is the case in most other centres), patients usually undergo EUS only after specialist evaluation, ordinarily in the out-patient clinic. Open access and direct-to-test endoscopy services have become commonplace in the United Kingdom, and elsewhere,11–15 particularly with the implementation of referral pathways for suspected GI 1

Clinical Lecturer, Gastrointestinal Research Group, Institute of Medical Sciences, University of Aberdeen, UK; Gastrointestinal and Liver Service, Aberdeen Royal Infirmary, UK 2 Consultant Gastroenterologist, Gastrointestinal and Liver Service, Aberdeen Royal Infirmary, UK Corresponding author: Perminder S Phull, Consultant Gastroenterologist, Gastrointestinal and Liver Service, Room 2.58, Ashgrove House, Aberdeen Royal Infirmary, Aberdeen AB25 2ZN, UK. Email: [email protected]

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malignancy.16 Experience from direct and open access endoscopy services suggest that these services are efficient and offer a high degree of patient satisfaction.11,13,14,16 Endoscopic ultrasonography is safe, constituting minimal additional risk beyond that associated with standard upper GI endoscopy,17 and is acceptable and well tolerated by patients.18,19 We are not aware, however, of any reports of direct-to-test EUS for patients with suspected choledocholithiasis, who have been referred by a primary care physician. We hypothesised that, in selected patients with suspected biliary pathology, direct-to-test EUS would be a valuable first-line investigation, would be safe, and would avoid specialist clinic review and the attendant delay, expense and patient inconvenience. Here, we present our initial data on direct-to-test EUS in a teaching hospital setting.

Methods and patient characteristics Twenty-eight patients, who had been referred for gastroenterology clinic evaluation at our institution between February 2005 and October 2010, were instead selected to be offered direct-to-test EUS. All referrals came from general practitioners (GPs), not from other hospital specialties. The referrals were reviewed by a single gastroenterologist, who also performed all subsequent direct-totest EUS procedures. Patients were selected on the basis of clinical history, symptomatology, and/or liver chemistry compatible with biliary pathology. For all but one patient, a TUS had already been performed at the request of the referring GP.

A standard EUS patient information leaflet accompanied the appointment letter for the procedure, which was sent by mail. All patients provided written informed consent and underwent day-case EUS under conscious sedation using an oblique-viewing radial echoendoscope (GFUM2000; Olympus KeyMed, Southend-on-Sea, UK). The median patient age was 52 years (range 21–83); 18 out of 28 patients were female (64%). In all cases, the indication for EUS was exclusion of choledocholithiasis. The clinical details available at the time of referral were: biliary-type pain with abnormal liver chemistry but no duct dilatation on TUS (n ¼ 14); abnormal liver chemistry with duct dilatation but no stones identified on TUS (n ¼ 5); biliary-type pain, normal liver chemistry and duct dilatation but no stones on TUS (n ¼ 3); isolated biliary-type pain (n ¼ 3); progressive cholestatic liver chemistry postcholecystectomy with no duct dilatation on ultrasound (n ¼ 2); unexplained recent pancreatitis with a normal TUS (n ¼ 1). Eight out of 28 patients (29%) had a history of previous cholecystectomy.

Results All patients accepted the direct-to-test EUS appointment, and a complete examination was possible in all cases. Seventeen (61%) of patients had abnormal EUS findings (Figure 1). The EUS findings were: choledocholithiasis (n ¼ 3); cholelithiasis (n ¼ 5); hepatic steatosis (n ¼ 2); hilar or coeliac lymphadenopathy (n ¼ 2); periampullary tumour (n ¼ 1). In addition, gastritis and/or duodenitis were noted on endoscopic examination in four (14%) patients with normal endoultrasonographic examinations.

Cholelithiasis 5 (18% ) Choledocholithiasis 3 (11% )

Normal 11 (39% )

Hepatic steatosis 2 (7% ) Gastroduodenitis 4 (14% )

Lymphadenopathy 2 Periampullary tumour (7% ) 1 (4% )

Figure 1. EUS findings in direct-to-test patients with suspected choledocholithiasis (n ¼ 28).

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Eleven patients (39%) had normal endoscopic and endoultrasonographic examinations. Three of the five cases of cholelithiasis had not been detected by TUS. Similarly, neither of the two cases of hepatic steatosis had been reported by TUS. The overall yield for novel pathology (i.e. findings not apparent from TUS) was therefore 54%. There were no noted complications in any of the 28 cases. On the basis of the EUS examination, seven patients were discharged directly back to the referring GP, three patients were referred for ERCP, three for cholecystectomy and one for surgical resection of a periampullary tumour (Figure 2). This equates to 14 of 28 (50%) patients being discharged or referred for a therapeutic procedure on the basis of the direct-to-test EUS findings. In the remaining 14 cases (50%), where EUS did not lead to discharge or definitive treatment, further out-patient investigation or follow up was arranged. Eventual diagnoses in this group included autoimmune hepatitis, primary biliary cirrhosis, drug-induced hepatitis, sphincter of Oddi dysfunction and non-ulcer dyspepsia.

Of the two cases of lymphadenopathy detected at EUS, one case of hepatic hilar lymphadenopathy was associated with PBC whilst the coeliac lymphadenopathy (which was borderline by size criteria) had resolved on follow-up EUS. Of the four patients with mucosal pathology identified on endoscopic examination, three were followed up at clinic and all reported an improvement in pain in response to treatment with a proton-pump inhibitor.

Discussion Our initial findings support the hypothesis that directto-test EUS for selected patients with suspected biliary disease is a safe investigation, with a high yield for significant pathology. For a large proportion of patients (50%), the EUS examination led to a definitive outcome without additional investigations or intervening clinic review. Mucosal pathology, that may have accounted for the pain reported at presentation, was identified in 14% of cases by endoscopic examination, and may help justify the choice of EUS as the mode

Direct-to-test EUS patients (n=28)

Normal examination (n=11)

Gastritis +/duodenitis (n=4)

Periampullary tumour (n=1)

Cholelithiasis (n=5)

Lymphadenopathy (n=2)

Hepatic steatosis (n=2)

Choledocholithiasis (n=3)

n=6 n=1 Discharged to primary care physician (n=7)

Whipple’s procedure (n=1)

Cholecystectomy (n=3)

n=2 n=3 n=5

Out patient follow-up (n=14)

Additional diagnoses included: • Autoimmune hepatitis • Primary biliary cirrhosis • Drug-induced hepatitis • Sphincter of Oddi dysfunction •Non-ulcer dyspepsia

Figure 2. Outcomes of patients who underwent direct-to-test EUS for suspected choledocholithiasis.

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ERCP (n=3)

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investigation in this patient group over, for example, MRCP. Limitations of our study include the limited number of cases, and the lack of cost analysis with reference to the standard pathway, comprising initial review in the clinic or direct-to-test upper GI endoscopy. Considering that the majority of pathology was detected on the basis of the ultrasonic examination, however, one would anticipate that, following clinic review and/or upper GI endoscopy, a definitive diagnosis would only have been reached in many of these patients by additional imaging investigations. A further caveat is that consideration for direct-to-test EUS was selective, having been at the discretion of a single clinician. Our cohort contained a high proportion of individuals who had already demonstrated their predisposition to biliary disease, as evidenced by the significant number of cases with a history of cholecystectomy. This may account for the relatively high frequency (11%) of choledocholithiasis. Owing to these potential sources of selection bias, we do not know whether our findings are generalisable to a department-wide service, where all gastroenterologists within an institution could select cases for direct-totest EUS from primary care referrals. Our findings do, however, compare favourably with the diagnostic yield for EUS as the initial investigation for upper abdominal pain.20 In a series of 172 patients with upper abdominal pain, Chang et al.20 reported that, in cases where the aetiology of pain was eventually established (38%), the diagnostic rate of EUS was 62%, and equivalent to parallel upper GI endoscopy and TUS. As with our study, no cost effectiveness analysis was performed. Similarly, in a randomized study of 240 patients with upper or right-sided abdominal pain, initial EUS appeared to be a valuable diagnostic modality compared to standard endoscopy combined with TUS.21 These two studies, with less exclusive selection criteria than our own, suggest that EUS has a yield sufficient to justify its use a first-line investigation (ahead of TUS) for upper abdominal pain. Given that a proportion of patients in our study went on to have eventual diagnoses of hepatic parenchymal disease (e.g. autoimmune hepatitis), it would be reasonable, in patients with abnormal liver chemistry being considered for direct-to-test EUS, that a liver disease screen first be performed in primary care, in an attempt to exclude other potential aetiologies. In conclusion, our experience suggests that direct-totest EUS may have a role in the initial assessment of patients with suspected biliary pathology. By avoiding an initial out-patient clinic appointment, this approach has the potential to provide a faster patient journey to a definitive diagnostic test. The generalisability of our findings and cost-effectiveness of the direct-to-test approach merit further study.

Declaration of conflicting interests The authors declare that there are no conflicts of interest.

Funding This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

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Initial experience of direct-to-test endoscopic ultrasonography for suspected choledocholithiasis.

Endoscopic ultrasound has become an invaluable tool in the investigation of patients with suspected pancreatobiliary disease. We set out to determine ...
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