ACR Appropriateness Criteria Jaundice EVIDENCE TABLE

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1 1. Bjornsson E, Ismael S, Nejdet S, Kilander A. Severe jaundice in Sweden in the new millennium: causes, investigations, treatment and prognosis. Scand J Gastroenterol 00; 8(1): Pasanen PA, Partanen KP, Pikkarainen PH, Alhava EM, Janatuinen EK, Pirinen AE. A comparison of ultrasound, computed tomography and endoscopic retrograde cholangiopancreatography in the differential diagnosis of benign and malignant jaundice and cholestasis. Eur J Surg 199; 159(1):-9. Objective (Purpose of ) 17 patients To assess the causes of jaundice in Gothenburg, Sweden, to study the types of investigations applied in cholestatic and hepatocellular types of jaundice and treatment and to evaluate the prognosis of these patients up to a year from the diagnosis. 0 total patients. Patients with jaundice (n=187) or cholestasis without jaundice (n=) Prospective study to assess accuracy of US, CT and ERCP in distinguishing between benign and malignant causes of jaundice and in determining cholestasis without jaundice. Results The most common cause of jaundice was malignancy in 58 patients, liver metastases in 0, cholangiocarcinoma in 16, pancreatic cancer in 1, cancer of papilla Vateri in and primary liver cancer in 7. Alcoholic liver disease was the second most common cause, found in 9 patients, followed by bile duct stones (8 patients). Only % had viral hepatitis. US and/or CT were performed in 95% of those with cholestasis and US had been performed in 75% of those with hepatocellular type and CT in almost 50%. patients were operated on, 7 patients were treated endoscopically and 17 patients required liver transplantation. Total mortality was 51% and in malignancy 8%. The benign nature of the extrahepatic obstruction was correctly defined by US, CT, and ERCP in 5%, 5%, and 90% of patients, respectively, and the corresponding figures for choledocholithiasis were %, 5%, and 79% (ERCP compared with each of the other techniques, P<0.0001). Intrahepatic benign diseases were diagnosed by US and CT in a third of cases. Malignant extrahepatic obstruction was correctly diagnosed in 57%, 80%, and 8%, respectively and the corresponding figures for pancreatic cancer were 60%, 97%, and 89% (US compared with CT, P<0.01, and with ERCP, P<0.05). Intrahepatic malignant lesions were diagnosed by US, CT, and ERCP in 100%, 77%, and 60% of patients, respectively. Results emphasize that the imaging methods are complementary. Page 1

2 . Aronson N, Flamm CR, Mark D, et al. Endoscopic retrograde cholangiopancreatography. Evid Rep Technol Assess (Summ) 00; (50):1-8.. Sharma SK, Larson KA, Adler Z, Goldfarb MA. Role of endoscopic retrograde cholangiopancreatography in the management of suspected choledocholithiasis. Surg Endosc 00; 17(6): Objective (Purpose of ) 19 studies To systematically review the evidence on the diagnostic and therapeutic effectiveness of ERCP. Four clinical conditions were addressed: (1) CBDS; () pancreaticobiliary malignancy; () pancreatitis; and () abdominal pain of possible pancreaticobiliary origin. Also, the evidence on determinants of complications of ERCP and on the prediction of CBDS were reviewed. 00 consecutive ERCP Retrospective study to determine role of ERCP in the management of suspected choledocholithiasis. Results Qualitative assessment of the available evidence suggests that: MRCP and EUS provide similar diagnostic performance as ERCP for detecting CBDS or malignant pancreaticobiliary obstruction. Sensitivity of nonsurgical tissue sampling techniques for detecting malignancy is similar or higher for brush cytology vs bile aspiration cytology, similar for FNA cytology vs brush cytology, and similar or higher for forceps biopsy vs brush cytology. Rigorous studies are needed to reliably quantify the relative performance of diagnostic ERCP compared to alternatives. Comparative studies of alternative diagnostic and treatment strategies for CBDS are urgently needed. Interventions intended to reduce complications of ERCP should incorporate prospectively defined studies to evaluate results. If multiple indications for ERCP were present, the diagnostic yield was 85.6%. With only one indication, diagnostic yield decreased to 5%. MRCP may be a more appropriate initial evaluation of suspected common bile duct pathology in many patients. Page

3 5. Krishna NB, Mehra M, Reddy AV, Agarwal B. EUS/EUS-FNA for suspected pancreatic cancer: influence of chronic pancreatitis and clinical presentation with or without obstructive jaundice on performance characteristics. Gastrointest Endosc 009; 70(1): patients; EUS evidence of chronic pancreatitis was present in 17 patients Objective (Purpose of ) Retrospective analysis of prospective database to determine the clinical value of EUS-FNA for pancreatobiliary malignancy diagnosis based on clinical presentation and presence of chronic pancreatitis. Results Pancreatobiliary malignancy diagnosis was diagnosed in 7.9% of patients with obstructive jaundice and biliary stricture or pancreatic mass, in 9.6% of patients with pancreatic mass, and in 7.0% of patients with an enlarged head of pancreas or dilated pancreatic duct +/- common bile duct. The prevalence of pancreatobiliary malignancy diagnosis was lower in all presentations with associated chronic pancreatitis. Both chronic pancreatitis and presentation with obstructive jaundice lowered performance characteristics of EUS-FNA, but chronic pancreatitis did so only in the subset of patients with obstructive jaundice. All except 1 false-negative diagnoses were due to cytologic misinterpretation. Among patients with suspected pancreatobiliary malignancy diagnosis, the accuracy of EUS-FNA is significantly lower only in a subset of patients with obstructive jaundice with underlying chronic pancreatitis, largely as a result of difficulty in cytologic interpretation. Page

4 6. Maranki J, Hernandez AJ, Arslan B, et al. Interventional endoscopic ultrasoundguided cholangiography: long-term experience of an emerging alternative to percutaneous transhepatic cholangiography. Endoscopy 009; 1(6): Ross WA, Wasan SM, Evans DB, et al. Combined EUS with FNA and ERCP for the evaluation of patients with obstructive jaundice from presumed pancreatic malignancy. Gastrointest Endosc 008; 68(): patients had EUSguided cholangiogra phy: 5 had biliary obstruction due to malignancy and 1 had a benign etiology Objective (Purpose of ) A report on 5 years of experience in patients who underwent interventional EUS-guided cholangiography after failed ERCP. 11 patients Retrospective single-center study to determine the feasibility and outcomes of combining EUS-FNA and a therapeutic ERCP into a single session. Results Overall success rate of interventional EUSguided cholangiography was 8% (1/9), with an overall complication rate of 16%. Of the 5 patients who underwent the intrahepatic approach, had a stent placed across the major papilla, one had a stent placed intraductally in the common bile duct, and three patients underwent placement of a gastrohepatic stent. Resolution of obstruction was achieved in 9 patients, with a success rate of 8%. In all, 1 patients underwent an extrahepatic approach. In 8/1 (57%), stent placement across the major papilla was achieved. A transenteric stent was placed in patients. Biliary decompression was achieved in 1/1 cases (86%). Based on intention-totreat analysis, the intrahepatic approach achieved success in 9/0 cases (7%), and the extrahepatic approach was successful in seven of nine cases (78%). There were no procedurerelated deaths. Interventional EUS-guided cholangiography offers a feasible alternative to PTC in patients with obstructive jaundice in whom ERC has failed. EUS-FNA had a sensitivity, specificity, PPV, NPV, and overall accuracy of 8.6%, 100%, 100%, 6.9%, and 87.8%, respectively. During an ERCP, endoscopic sphincterotomies were performed in 51 patients, and biliary stents were placed in 96 patients. 1 patients (10.5%) had a complication, with 6 having postprocedural pancreatitis. Combined EUS- FNA and therapeutic ERCP is technically feasible, with a complication rate no higher than the component procedures, while efficiently providing tissue diagnosis and biliary drainage. Page

5 8. Sai JK, Suyama M, Kubokawa Y, Watanabe S, Maehara T. Early detection of extrahepatic bile-duct carcinomas in the nonicteric stage by using MRCP followed by EUS. Gastrointest Endosc 009; 70(1): Saifuku Y, Yamagata M, Koike T, et al. Endoscopic ultrasonography can diagnose distal biliary strictures without a mass on computed tomography. World J Gastroenterol 010; 16():7-. 1 patients had MRCP; reviewers Objective (Purpose of ) Prospective single study to examine the usefulness of MRCP followed by EUS in the early diagnosis of extrahepatic bile-duct carcinoma in the nonicteric stage. patients Retrospective study to assess the diagnostic ability of EUS for evaluating causes of distal biliary strictures shown on ERCP or MRCP, even without identifiable mass on CT. Results 6/1 patients underwent EUS. Ten patients (5 with stricture, with filling defect, and 1 with no stricture or filling defect) had extrahepatic bile-duct carcinoma, including 5 patients with an incidentally diagnosed T1 stage tumor. Sensitivity and specificity of MRCP followed by EUS were 90% and 98%, respectively. MRCP followed by EUS was highly sensitive and specific for the early diagnosis of extrahepatic bile-duct carcinoma in the nonicteric stage, including T1 stage tumors. Filling defects, as well as stenosis in the bile duct, are important MRCP findings of T1 stage carcinoma. 17 patients (50%) were finally diagnosed with benign conditions, including 6 normal subjects, while 17 patients (50%) were diagnosed with malignant disease. In terms of diagnostic ability, EUS showed 9.1% sensitivity, 8.% specificity, 8.% PPV, 9.% NPV and 88.% accuracy for identifying malignant and benign strictures. EUS was more sensitive than routine cytology (9.1% vs 6.5%, P=0.09). NPV was also better for EUS than for routine cytology (9.% vs 57.5%, P=0.05). In addition, EUS provided significantly higher sensitivity than tumor markers using 100 U/mL as the cutoff level of carbohydrate antigen 19-9 (9.1% vs 5%, P=0.017). On EUS, biliary stricture that was finally diagnosed as malignant showed as a hypoechoic, irregular mass, with obstruction of the biliary duct and invasion to surrounding tissues. EUS can diagnose biliary strictures caused by malignant tumors that are undetectable on CT. Earlier detection by EUS would provide more therapeutic options for patients with early-stage pancreaticobiliary cancer. Page 5

6 10. Poynard T, Chaput JC, Etienne JP. Relations between effectiveness of a diagnostic test, prevalence of the disease, and percentages of uninterpretable results. An example in the diagnosis of jaundice. Med Decis Making 198; (): Chen WX, Xie QG, Zhang WF, et al. Multiple imaging techniques in the diagnosis of ampullary carcinoma. Hepatobiliary Pancreat Dis Int 008; 7(6): Tongdee T, Amornvittayachan O, Tongdee R. Accuracy of multidetector computed tomography cholangiography in evaluation of cause of biliary tract obstruction. J Med Assoc Thai 010; 9(5): N/A 1 patients (all patients examined by US, and 9 of them received enhanced CT, 9 MRCP, and 5 ERCP) Objective (Purpose of ) Ten hepatologists and 10 hepatobiliary surgeons were interviewed, and 19 articles were reviewed to study the relations between effectiveness of a diagnostic test, prevalence of the disease, and percentages of uninterpretable results in the diagnosis of jaundice. Retrospective study to evaluate the efficacy of abdominal US, enhanced CT, MRCP and ERCP in detecting ampullary carcinoma. Accuracy of US, CT, MRCP and ERCP were compared in the diagnosis of ampullary carcinoma. 50 patients Retrospective study to evaluate accuracy of MDCT cholangiography in evaluation of cause of biliary tract obstruction. Results Effectiveness must take into account the percentages of uninterruptible results and must be expressed as a function of prevalence. The accurate rate for detection of ampullary carcinoma with US was 6.8%. The accuracy of CT and ERCP in detection of ampullary tumors was 8.6% and 100%, respectively, which were significantly higher than that of US (P<0.05). The accuracy of MRCP in detection of ampullary tumors was similar to that of US in spite of visualization of obstruction and dilatation of the pancreaticobiliary duct with MRCP. Because of the obscure and late onset of symptoms, ampullary carcinoma is difficult to diagnose early. Multiple imaging techniques should be carried out appropriately in order to early diagnose the disease and improve the prognosis. Sensitivity, specificity, PPV, and NPV of MDCT cholangiography for detection of calculus, benign stricture, and malignancy were 91.7%-100%, except for sensitivity and PPV for detection of benign stricture, which were 66.7% and 66.7% respectively. MDCT cholangiography is a fast, noninvasive technique that offers high diagnostic accuracy in evaluation of cause of biliary tract obstruction. Page 6

7 1. Tseng CW, Chen CC, Chen TS, Chang FY, Lin HC, Lee SD. Can computed tomography with coronal reconstruction improve the diagnosis of choledocholithiasis? J Gastroenterol Hepatol 008; (10): Bang BW, Jeong S, Lee DH, Kim CH, Cho SG, Jeon YS. Curved planar reformatted images of MDCT for differentiation of biliary stent occlusion in patients with malignant biliary obstruction. AJR 010; 19(6): patients; 16 choledocholit hiasis patients divided into three groups Objective (Purpose of ) To determine if CT with coronal reconstruction can aid in the diagnosis of choledocholithiasis. Group 1-9 undergoing CT using 5-mm thick sections with coronal reconstruction; Group - undergoing CT using 5-mm thick sections without coronal reconstruction; and Group - 9 undergoing CT using 7-mm thick sections without coronal reconstruction. 17 patients To prospectively evaluate the usefulness of MDCT using a curved planar reformation technique for the noninvasive assessment of the causes of biliary stent occlusion in patients with malignant biliary obstruction. Results Sensitivity and specificity of CT in diagnosing choledocholithiasis were 77.% and 7.8%. There was no significant difference of CT diagnostic rate among the three groups (75.0%, 81.% and 79.5%, respectively). The diameter of common bile duct, size of CBDS and white cell count showed significant differences between CT true-positive and false-negative cases in group 1 patients. The CT diagnostic rate was significantly lower in patients with choledocholithiasis of <5 mm than in patients with choledocholithiasis of 5 mm (56.5% vs 81.%). The coronal reconstruction of CT imaging did not increase its diagnostic efficacy on choledocholithiasis. The stone size affects the diagnostic rate of abdominal CT for detecting choledocholithiasis. The differences in attenuation value inside the biliary stent between the contrast-enhanced and unenhanced phases of CT in the tissue growth group was 7.7 +/- 1.7 HU and. +/ HU in the stent-clogging group (P=0.00). The sensitivity and specificity of MDCT for the diagnosis of tissue growth were 86.7% and 85.7%, respectively. The overall accuracy of curved planar reformation images of MDCT for diagnosing the causes of stent occlusion was 86.%. Curved planar reformation MDCT is a useful noninvasive technique that is relatively accurate for diagnosing the cause of biliary stent occlusion and is helpful for planning the therapeutic management of such patients. Page 7

8 15. Anderson SW, Lucey BC, Varghese JC, Soto JA. Accuracy of MDCT in the diagnosis of choledocholithiasis. AJR 006; 187(1): Choi YH, Lee JM, Lee JY, et al. Biliary malignancy: value of arterial, pancreatic, and hepatic phase imaging with multidetector-row computed tomography. J Comput Assist Tomogr 008; (): patients patients had scans performed with IV contrast agent only, 15 patients had scans performed without IV contrast agent only, had studies with and without an IV contrast agent patients; independent observers Objective (Purpose of ) To evaluate the diagnostic performance of contrast-enhanced and unenhanced MDCT performed for various indications, in detecting choledocholithiasis. Retrospective study to assess the diagnostic value of arterial, pancreatic, and hepatic phase imaging with MDCT of a bile duct malignancy. Results Unenhanced and contrast-enhanced MDCT images, interpreted in PACS workstations with axial images, are moderately sensitive and specific for showing choledocholithiasis. The degree of tumor conspicuity was higher in the pancreatic and hepatic phases than in the arterial phase (P<0.01); however, there was no statistical difference in tumor conspicuity between the pancreatic and hepatic phases (P>0.05). The mean tumor attenuation was greater in the hepatic phase at 11. +/-.6 HU vs 7.9 +/- 18. HU in the arterial phase (P<0.001). The images obtained in the hepatic phases were significantly superior to those obtained in the arterial phase for predicting the tumor involvement into the secondary biliary confluence (P<0.05). In predicting for the vascular involvement by the tumors, there was no significant difference among the enhancement phases (P>0.05). Routine acquisition of arterial phase images is not necessary for successful detection and evaluation of the extent of hilar or extrahepatic bile duct carcinoma. Page 8

9 17. Park HS, Lee JM, Choi JY, et al. Preoperative evaluation of bile duct cancer: MRI combined with MR cholangiopancreatography versus MDCT with direct cholangiography. AJR 008; 190(): Aube C, Delorme B, Yzet T, et al. MR cholangiopancreatography versus endoscopic sonography in suspected common bile duct lithiasis: a prospective, comparative study. AJR 005; 18(1): patients; independent reviewers Objective (Purpose of ) Retrospective study to compare the performance of MRI combined with MRCP with that of MDCT combined with direct cholangiography in the evaluation of the tumor extent and resectability of bile duct cancer with surgical and pathologic findings as the reference standard. 7 patients To prospectively compare diagnostic accuracy of MRCP and EUS for the diagnosis of CBDS in patients with a mild to moderate clinical suspicion of CBDS. Results For each reviewer, the overall accuracy rates for predicting involvement of the bilateral secondary biliary confluences and the intrapancreatic common bile duct were 90.7% and 87.0% for MRI with MRCP and 85.1% and 87.0% for MDCT with direct cholangiography. The differences were not statistically significant for either image set for either reviewer (P>0.05). In the assessment of vascular involvement, lymph node metastasis, and tumor resectability, the readers diagnostic performance using MRI with MRCP was similar to that with MDCT with direct cholangiography (P>0.05). In the diagnosis of bile duct cancer with a noninvasive procedure, the information regarding tumor extent and resectability obtained with contrast-enhanced MRI combined with MRCP is comparable with that obtained with MDCT with direct cholangiography. The sensitivity and specificity of MRCP were, respectively, 90.5% and 87.5% for etiologic diagnosis and 87.5% and 96.6% for the detection of CBDS. The corresponding values for EUS were 86.% and 91.% for etiologic diagnosis and 9.8% and 96.6% for visualization of choledocholithiasis. Page 9

10 19. Choi JY, Lee JM, Lee JY, et al. Navigator-triggered isotropic threedimensional magnetic resonance cholangiopancreatography in the diagnosis of malignant biliary obstructions: comparison with direct cholangiography. J Magn Reson Imaging 008; 7(1): Maurea S, Caleo O, Mollica C, et al. Comparative diagnostic evaluation with MR cholangiopancreatography, ultrasonography and CT in patients with pancreatobiliary disease. Radiol Med 009; 11():90-0. Objective (Purpose of ) patients To retrospectively compare the diagnostic accuracy of navigator-triggered isotropic D- MRCP using parallel imaging for malignant biliary obstruction with direct cholangiography. Patients with malignant biliary obstruction underwent MRCP and ERCP/PTC. 70 patients MRCP performed in all patients abdominal US: 55 patients (group 1) multislice CT: 7 patients (group ) To directly compare the results of MRCP with those of US and multislice CT in the diagnosis of pancreaticobiliary diseases. Histology (n=7), biopsy (n=5), ERCP (n=8) and/or clinical-imaging follow-up (n=10) were considered standards of reference. Results D-MRCP was of diagnostic quality and free of artifacts in all patients, whereas ERCP/PTC examinations failed in patients. For the evaluation of level of obstruction, there was no statistical significance between D-MRCP and ERCP/PTC. D-MRCP was superior to ERCP/PTC in the assessment of anatomical extent of hilar bile duct involvement, but did not show statistical significance. The accuracy of D-MRCP in determining tumoral extent of hilar cancer was higher than that of ERCP/PTC, but it was not statistically significant. The image quality of D-MRCP was superior to ERCP/PTC. There was good agreement between morphologic appearance at MRCP and those at ERCP/PTC. D-MRCP can accurately assess the level of obstruction and extent of tumor in patients with malignant biliary obstruction. Group 1 - the results of MRCP and US were concordant in the majority (9%) of cases; however, statistically significant discordance (P<0.01) was found in the evaluation of the extrahepatic ducts, with 9 cases (16%) of middle-distal CBDS being detected on MRCP only. Group - the results of MRCP and multislice CT were also concordant in most cases (87%). However, findings were significantly discordant when the intra- and extrahepatic ducts were analyzed, with 7 (19%) and 6 (16%) cases, respectively, of lithiasis being detected on MRCP only (P<0.01 for both). results confirm the diagnostic potential of MRCP in the study of the pancreaticobiliary duct system. In particular, the comparison between MRCP and US and multislice CT indicates the superiority of MRCP in evaluating bile ducts and detecting stones in the common bile duct. Page 10

11 1. Williams EJ, Green J, Beckingham I, Parks R, Martin D, Lombard M. Guidelines on the management of common bile duct stones (CBDS). Gut 008; 57(7): Oto A, Ernst R, Ghulmiyyah L, Hughes D, Saade G, Chaljub G. The role of MR cholangiopancreatography in the evaluation of pregnant patients with acute pancreaticobiliary disease. Br J Radiol 009; 8(976): N/A 18 pregnant patients had MRCP; 15 patients evaluated with US Objective (Purpose of ) Guidelines on the diagnosis and treatment of patients with CBDS. Retrospective review of MRI and patient charts to determine the usefulness of MRCP in the evaluation of pregnant patients with acute pancreaticobiliary disease and its additional value over US. Results It is recommended that wherever patients have symptoms, and investigation suggests ductal stones, extraction should be performed if possible. Trans-abdominal US is recommended as a preliminary investigation for CBDS and can help identify patients who have a high likelihood of ductal stones. However, clinicians should not consider it a sensitive test for this condition. Where patients with suspected CBDS have not been previously investigated initial assessment should be based on clinical features, liver function tests and US findings. EUS and MRI are both recommended as being highly effective at confirming the presence of CBDS. When selecting between the two modalities patient suitability, accessibility and local expertise are the most important considerations. Biliary dilatation was detected in 8 patients by US. MRCP demonstrated the etiology in of these patients (choledocholithiasis (n=1), Mirizzi syndrome (n=1), choledochal cyst (n=1) and intrahepatic biliary stones (n=1)) and excluded obstructive pathology in the other patients. MRCP appears to be a valuable and safe technique for the evaluation of pregnant patients with acute pancreaticobiliary disease. Page 11

12 . Hekimoglu K, Ustundag Y, Dusak A, et al. MRCP vs. ERCP in the evaluation of biliary pathologies: review of current literature. J Dig Dis 008; 9(): Lee DH, Lee JM, Kim KW, et al. MR imaging findings of early bile duct cancer. J Magn Reson Imaging 008; 8(6): total patients 17 patients; reviewers Objective (Purpose of ) To compare the diagnostic potential of one of the new MR sequences in MRCP procedure and ERCP with review of current literatures. Patients were prospectively enrolled in this study. To retrospectively evaluate the MRI features of early bile duct cancer and to correlate them with the clinicopathologic findings. Results The study participants were classified into four main groups; normal into group I, stone disease into group II, tumor into group III and others into group IV. Group I consisted of 8 patients who had a normal pancreaticobiliary tree on both the MRCP and ERCP examinations. In group II there were 18 patients, for whom the MRCP had a 88.9% sensitivity and a 100% specificity for diagnosing biliary stone disease. It s PPV, NPV and accuracy rates were 100%, 99.% and 99.%, respectively. The MRCP had 100% sensitivity and a 100% specificity for 0 patients in group III. It also had 100% PPV, 100% NPV, and 100% total accuracy rates in this group. In three patients in group IV, the MRCP had a 100% sensitivity and specificity, respectively. Its PPV, NPV and accuracy were 100%, 100% and 100%, respectively. MRCP is used with increasing frequency as a noninvasive alternative to ERCP and the diagnostic results of MRCP with a heavily T- weighted MR sequence and ERCP are comparable with high accuracy in various hepatobiliary pathologies. In all patients, MRI demonstrated single or multiple intraluminal bile duct masses showing a sharply defined outer margin. The most common enhancement pattern of the biliary lesions showed heterogeneous amorphous enhancement or heterogeneous enhancement with central, dot-like structures or vascular structures (76.5%, 1/17 patients). The difference of signal to noise ratio between bile duct and tumor was greatest in the equilibrium phase (P<0.05). MRCP combined with dynamic contrast-enhanced MRI can be useful for detecting early bile duct cancers. Common MRI findings of early bile duct cancer include one or more inhomogeneously enhancing intraductal masses with clear outer margins and preservation of the bile duct wall. 1 Page 1

13 5. Masselli G, Manfredi R, Vecchioli A, Gualdi G. MR imaging and MR cholangiopancreatography in the preoperative evaluation of hilar cholangiocarcinoma: correlation with surgical and pathologic findings. Eur Radiol 008; 18(10): Ryoo I, Lee JM, Chung YE, et al. Gadobutrol-enhanced, three-dimensional, dynamic MR imaging with MR cholangiography for the preoperative evaluation of bile duct cancer. Invest Radiol 010; 5(): patients; reviewers 60 patients; reviewers Objective (Purpose of ) Retrospective study to evaluate delayed contrast-enhanced MRI in depicting perineural spread of hilar cholangiocarcinoma and consequently to determine the capability of MRI/MRCP for staging cholangiocarcinoma. To retrospectively evaluate the diagnostic performance of 1.0-M gadobutrol-enhanced, D, dynamic MRI with D-MR cholangiography in the preoperative evaluation of bile duct cancer staging and resectability. Surgical and pathology findings were used as the reference standards. Results Overall accuracy in detecting biliary neoplastic invasion was higher for delayed T1-weighted images (9.%) than for the MRCP images (80%), and T1-delayed image increased the MR accuracy in assessing the neoplastic resectability (P<0.05). MRI correctly predicted vascular involvement in 7% and liver involvement in 80% of the cases. The number of overall correctly assessed patients with regard to resectability was 11 true positive, 1 false positive and true negative. The combination of MRI/MRCP is a reliable diagnostic method for staging hilar cholangiocarcinomas. Delayed periductal enhancement is accurate in the evaluation of neoplastic perineural spread, and it can improve diagnostic accuracy to identify resectable and unresectable tumors. The AUC of the reviewers was 0.95 and 0.9, respectively, for evaluation of the involvement of both secondary biliary confluences and 0.85 and 0.8, respectively, for assessment of the intrapancreatic duct. For determining the tumor resectability, the overall accuracy was 0.9 and 0.88, respectively, whereas for assessment of the vascular involvement, the AUC values were 0.9 for reviewer 1 and 0.70 for reviewer for the portal vein evaluation, and 0.99 for reviewer 1 and 0.76 for reviewer for the hepatic artery evaluation. In the assessment of lymph node metastasis, the overall accuracy was approximately 0.77 for each reviewer. Onemolar, gadobutrol-enhanced, dynamic imaging, using a D-gadobutrol-enhanced technique with isotropic D-MR cholangiography showed excellent diagnostic capability for assessing the longitudinal extent and tumor resectability of bile duct cancer, although it generally underestimated the tumor involvement of vessels and lymph nodes. Page 1

14 7. Yu SA, Zhang C, Zhang JM, et al. Preoperative assessment of hilar cholangiocarcinoma: combination of cholangiography and CT angiography. Hepatobiliary Pancreat Dis Int 010; 9(): Costamagna G, Familiari P, Marchese M, Tringali A. Endoscopic biliopancreatic investigations and therapy. Best Pract Res Clin Gastroenterol 008; (5): Lim JH. Cholangiocarcinoma: morphologic classification according to growth pattern and imaging findings. AJR 00; 181(): Caddy GR, Tham TC. Gallstone disease: Symptoms, diagnosis and endoscopic management of common bile duct stones. Best Pract Res Clin Gastroenterol 006; 0(6): total patients: 9 PTC, 1 ERCP, MRCP N/A N/A N/A Objective (Purpose of ) To evaluate the clinical value of cholangiography combined with spiral D-CT angiography for a preoperative assessment of hilar cholangiocarcinoma. A review on endoscopic biliopancreatic interventions. To describe the gross appearance of intrahepatic and extrahepatic cholangiocarcinomas, correlate the pathologic and imaging findings, consider the mode of spread of these tumors, and discuss the clinical significance of the various growth patterns of cholangiocarcinoma. To review clinical presentation, investigation and current management of bile duct stones. Results The data from 5/1 patients were consistent with those on invasion of the portal vein. The results of the Bismuth classification and the T- staging system were consistent with those of surgical exploration in 1/1 patients. 7/8 patients who were estimated to be suitable for operation based on images were curatively treated and 5 who were judged to be unsuitable for curative operation by cholangiography and CT angiography were confirmed intraoperatively and underwent palliative procedures. Cholangiography combined with multi-slice spiral D-CT angiography can satisfactorily delineate the local invasion of hilar cholangiocarcinoma and accurately evaluate the resectability. This approach, therefore, contributes to the planning of safe operation. Endoscopic biliopancreatic interventions should be performed only by ERCP-dedicated endoscopists. ERCP training can help in improving overall ERCP performance. Morphologic classification of cholangiocarcinoma is useful for understanding the biological behavior of this tumor as well as for planning and choosing the appropriate treatment and for predicting prognosis. Transabdominal US is a sensitive test in detecting bile duct dilatation but the sensitivity is reduced in its ability to detect choledocholithiasis. A NIH consensus statement found that ERCP, MRCP and EUS were comparable in their sensitivities, specificities and accuracy rates for detection of choledocholithiasis. Page 1

15 1. Raijman I. Biliary and pancreatic stents. Gastrointest Endosc Clin N Am 00; 1():561-59, vii-viii.. Costamagna G, Tringali A, Petruzziello L, Spada C. Hilar tumours. Can J Gastroenterol 00; 18(7): Krishna NB, LaBundy JL, Saripalli S, Safdar R, Agarwal B. Diagnostic value of EUS-FNA in patients suspected of having pancreatic cancer with a focal lesion on CT scan/mri but without obstructive jaundice. Pancreas 009; 8(6): N/A Objective (Purpose of ) To review the most recent available data concerning biliary and pancreatic stents and discuss possible future developments. N/A Review specific technical details, describe comparative trials of unilateral vs bilateral biliary drainage and explore new techniques that warrant further investigation. 1 patients Retrospective analysis of a prospective database. To evaluate the performance characteristics of EUS-FNA in patients suspected of having pancreatic cancer with a focal lesion on CT scan/mri but without obstructive jaundice. Results Use of biliary and pancreatic stents has increased significantly during the last decades because of improvements in available endoscopes and endoscopic accessories, as well as better techniques. The number of endoscopists who can successfully complete these demanding procedures has also increased, as have the indications for stent therapy in biliary and pancreatic diseases. Review does not attempt to cover all data reported in biliopancreatic stent therapy. No results stated. Focal pancreatic lesion was identified in 17 patients by EUS. The final diagnosis included adenocarcinoma (n=89), neuroendocrine tumor (n=1), mucinous cystadenocarcinoma (n=1), solid pseudopapillary tumor (n=), metastases (n=), benign cyst (n=19), pseudocyst (n=9), abscess (n=), chronic pancreatitis (n=), and normal pancreas (n=9). EUS-FNA had an accuracy of 97.6% for diagnosing malignant neoplasm, with 96.6% sensitivity, 99.0% specificity, 96.% NPV, and 99.1% PPV. EUS-FNA is highly accurate for diagnosing malignancy in patients with a focal pancreatic lesion on CT scan/mri but without obstructive jaundice. EUS-FNA can potentially be used as a definitive diagnostic test in the management of these patients. Page 15

16 . Bortoff GA, Chen MY, Ott DJ, Wolfman NT, Routh WD. Gallbladder stones: imaging and intervention. Radiographics 000; 0(): Ripolles T, Ramirez-Fuentes C, Martinez- Perez MJ, Delgado F, Blanc E, Lopez A. Tissue harmonic sonography in the diagnosis of common bile duct stones: a comparison with endoscopic retrograde cholangiography. J Clin Ultrasound 009; 7(9): N/A Objective (Purpose of ) Review of various imaging and intervention of gallbladder stones. 107 patients To revisit the diagnostic accuracy of US in the detection of choledocholithiasis using modern equipment with tissue harmonic imaging and ERCP with sphincterotomy as the gold standard. Results US is the method of choice for detection of gallstones. The characteristic US findings of gallstones are a highly reflective echo from the anterior surface of the gallstone, mobility of the gallstone on repositioning the patient, and marked posterior acoustic shadowing. Oral cholecystography remains an excellent method of gallstone detection, but its role has been limited due to the advantages of US. The primary imaging modality in suspected acute calculous cholecystitis is usually US or cholescintigraphy. In certain clinical settings, interventional radiologic procedures have become an important alternative to surgery in the treatment of gallstones and their complications; techniques include percutaneous cholecystostomy and gallstone removal. US correctly detected stones in 65/76 patients (sensitivity of 86%). The specificity and the overall accuracy were 87% and 86%, respectively. The sensitivity of US was higher with dilated extrahepatic duct (% in patients with common bile duct measuring <6 mm in diameter, 8% between 6 and 10 mm, and 100% with common bile duct >10 mm). The lateral approach with the patient in left lateral decubitus position of the patient was the most effective in 7% of the cases. US with tissue harmonic imaging is an accurate technique for the detection of choledocholithiasis that may be used as the first-choice technique to avoid unnecessary procedures in a high percentage of patients, especially those with dilated biliary tree. Page 16

17 6. Kondo S, Isayama H, Akahane M, et al. Detection of common bile duct stones: comparison between endoscopic ultrasonography, magnetic resonance cholangiography, and helical-computedtomographic cholangiography. Eur J Radiol 005; 5(): Scaffidi MG, Luigiano C, Consolo P, et al. Magnetic resonance cholangiopancreatography versus endoscopic retrograde cholangio-pancreatography in the diagnosis of common bile duct stones: a prospective comparative study. Minerva medica 009; 100(5): Maple JT, Ben-Menachem T, Anderson MA, et al. The role of endoscopy in the evaluation of suspected choledocholithiasis. Gastrointest Endosc 010; 71(1):1-9. Objective (Purpose of ) 8 patients Prospective study to compare the diagnostic ability of EUS, MRCP, and helical CT cholangiography in patients with suspected CBDS. Each patient underwent EUS, MRCP, and helical CT cholangiography prior to ERCP, the result of which served as the diagnostic gold standard. 10 patient To prospectively evaluate sensitivity, specificity, diagnostic accuracy, PPV and NPV of MRCP in diagnosis of choledocholithiasis using ERCP/endoscopic sphincterotomy as gold standard. N/A Guideline document on the role of endoscopy in patients with suspected choledocholithiasis. Results CBDS were detected in (86%) of 8 patients by ERCP/EUS. The sensitivity of EUS, MRCP, and helical CT cholangiography was 100%, 88%, and 88%, respectively. False negative cases for MRCP and helical CT cholangiography had a CBDS <5 mm in diameter. No serious complications occurred while one patient complained of itching in the eyelids after the infusion of contrast agent on helical CT cholangiography. When examination can be scheduled, MRCP or helical CT cholangiography will be the first choice because they were less invasive than EUS. MRCP and helical CT cholangiography had similar detectability but the former may be preferable considering the possibility of allergic reaction in the latter. When MRCP is negative, EUS is recommended to check for small CBDS. 10/10 patients completed the study. MRCP diagnosed lithiasis of CBDS in 8. ERCP confirmed the lithiasis in 7/8 patients who were submitted to endoscopic sphincterotomy. Eleven were negative after endoscopic sphincterotomy. ERCP documented stones in 10 patients among the 6 negative at MRCP; stones were detected only in patients after endoscopic sphincterotomy. In 6/6 patients negative at MRCP, ERCP confirmed this response: only 1/6 patients underwent endoscopic sphincterotomy. The sensitivity, specificity, diagnostic accuracy, PPV and NPV of MRCP were: 88%, 7%, 8%, 87%, and 7%, respectively. As the MRCP diagnostic yield is still limited with small stones, the question of which patient is the best candidate to ERCP/endoscopic sphincterotomy is still unsolved. No results stated. Page 17

18 9. Kim TU, Kim S, Lee JW, et al. Ampulla of Vater: comprehensive anatomy, MR imaging of pathologic conditions, and correlation with endoscopy. Eur J Radiol 008; 66(1): Furukawa H, Ikuma H, Asakura-Yokoe K, Uesaka K. Preoperative staging of biliary carcinoma using 18F-fluorodeoxyglucose PET: prospective comparison with PET+CT, MDCT and histopathology. Eur Radiol 008; 18(1): N/A Objective (Purpose of ) To review the normal anatomy of the ampulla of Vater, describe the role of MR in the detection and characterization of the lesion in or around the ampulla of Vater, and correlate them with ERCP. 7 patients To evaluate the value of positron emission tomography with FDG-PET as a preoperative diagnostic investigation in patients with biliary carcinoma. Patients underwent preoperative MDCT and FDG-PET. Both diagnoses were compared with subsequent histopathology and follow-up results. Results ERCP is the most accurate tool for diagnosing neoplastic and non-neoplastic conditions in or around the ampulla of Vater. However, ERCP involves inherent morbidity because of its invasiveness. MRCP can provide global information on the pancreaticobiliary tree noninvasively in patients with suspected or known pancreaticobiliary disease. Additional conventional MRI might provide valuable information in distinguishing between neoplastic and non-neoplastic conditions. The dynamic D-gadobutrol-enhanced sequence might assist in depicting and characterizing the abnormal papilla. MRI in conjunction with MRCP may be helpful for making an accurate assessment of the ampulla of Vater as well as for distinguishing between neoplastic and nonneoplastic conditions. In 6 lesions with biliary carcinoma, 57 (89%) revealed an intense focal accumulation on FDG-PET and were interpreted as malignant. On the other hand, 8 benign lesions did not show any specific accumulation. Detection rate of FDG-PET in the nodular type of the tumor (96% or 7/8) was superior to that of the infiltrating type (7% or 17/) (P=0.07). For the evaluation of lymph node metastasis, the overall accuracy was 69% (5/51) in both FDG-PET and MDCT: FDG-PET had a lower sensitivity (% vs 57%) and a higher specificity (97% vs 79%) than MDCT, although the values were not significantly different. FDG-PET revealed all 6 lesions of distant metastases in 6 patients including two lesions missed by MDCT. FDG-PET has high detectability of biliary malignancies. Like MDCT, FDG-PET offers only modest accuracy for regional lymph node staging, but it may reveal distant metastases missed by MDCT. Page 18

19 1. Seo H, Lee JM, Kim IH, et al. Evaluation of the gross type and longitudinal extent of extrahepatic cholangiocarcinomas on contrast-enhanced multidetector row computed tomography. J Comput Assist Tomogr 009; (): Choi JY, Kim MJ, Lee JM, et al. Hilar cholangiocarcinoma: role of preoperative imaging with sonography, MDCT, MRI, and direct cholangiography. AJR 008; 191(5): patients; reviewers N/A Objective (Purpose of ) Retrospective study to determine the accuracy of contrast-enhanced MDCT in classifying the morphological subtype and revealing the longitudinal extent of extrahepatic cholangiocarcinomas. Image analysis results were compared with the pathological findings. To review the roles of US, MDCT, MRI, and direct cholangiography in the evaluation of hilar cholangiocarcinoma. Results The accuracy of MDCT for morphological classification was 78.6% (/56). The differences between the radiological and pathological measurements of the longitudinal extent of the tumors ranged from 0 to 5.5 mm, with a mean of 5.89 mm (11. mm). There was moderate correlation between the measurements of the longitudinal extent of the tumors (P<0.05, gamma = 0.55). In 5 patients, MDCT measurements did not differ significantly from the pathological measurements (6.5%).In 18 patients; CT underestimated the longitudinal extent of the tumor by more than 6 mm (.1%). In the 9 patients with multiplanar reconstruction images, the correlation between the CT and the pathological measurements of the longitudinal extent was better in the combined interpretation of the axial and coronal images (P<0.05, gamma = 0.15) than that in the interpretation of only the axial images (P>0.05, gamma = 0.65). Results demonstrate that MDCT can correctly classify the morphological subtype of extrahepatic cholangiocarcinoma. Nevertheless, CT has a strong tendency to underestimate the longitudinal tumor extent compared with the pathological results. Hilar cholangiocarcinoma is a primary malignant tumor typically located at the confluence of the right and left ducts within the porta hepatis. Staging of hilar cholangiocarcinoma with various imaging techniques is crucial for management, and a comprehensive approach is needed for accurate preoperative assessment. Page 19

20 Evidence Table Key Category Definitions Category 1 The study is well-designed and accounts for common biases. Category The study is moderately well-designed and accounts for most common biases. Category There are important study design limitations. Category The study is not useful as primary evidence. The article may not be a clinical study or the study design is invalid, or conclusions are based on expert consensus. For example: a) the study does not meet the criteria for or is not a hypothesis-based clinical study (e.g., a book chapter or case report or case series description); b) the study may synthesize and draw conclusions about several studies such as a literature review article or book chapter but is not primary evidence; c) the study is an expert opinion or consensus document. = Diagnostic Tx = Treatment Abbreviations Key AUC = Areas under the receiver operating characteristic curve CBDS = Common bile duct stones CT = Computed tomography ERCP = Endoscopic retrograde cholangiopancreatography EUS = Endoscopic ultrasound FDG-PET = Fluorine-18--fluoro--deoxy-D-glucose-positron emission tomography FNA = Fine-needle aspiration HU = Hounsfield units MDCT = Multidetector computed tomography MRCP = Magnetic resonance cholangiopancreatography MRI = Magnetic resonance imaging NPV = Negative predictive value PPV = Positive predictive value PTC = Percutaneous transhepatic cholangiography US = Ultrasound ACR Appropriateness Criteria Evidence Table Key

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