Increasing numbers of incidental pancreatic lesions are being detected each year. Accurate characterisation of pancreatic lesions into benign, precancerous, and cancer masses is crucial in deciding whether to use treatment or surveillance. Distinguishing benign lesions from precancerous and cancerous lesions can prevent patients from undergoing unnecessary major surgery. Despite the importance of accurately classifying pancreatic lesions, there is no clear algorithm for management of focal pancreatic lesions.

To determine and compare the diagnostic accuracy of various imaging modalities in detecting cancerous and precancerous lesions in people with focal pancreatic lesions.

We searched the CENTRAL, MEDLINE, Embase, and Science Citation Index until 19 July 2016. We searched the references of included studies to identify further studies. We did not restrict studies based on language or publication status, or whether data were collected prospectively or retrospectively.

We planned to include studies reporting cross-sectional information on the index test (CT (computed tomography), MRI (magnetic resonance imaging), PET (positron emission tomography), EUS (endoscopic ultrasound), EUS elastography, and EUS-guided biopsy or FNA (fine-needle aspiration)) and reference standard (confirmation of the nature of the lesion was obtained by histopathological examination of the entire lesion by surgical excision, or histopathological examination for confirmation of precancer or cancer by biopsy and clinical follow-up of at least six months in people with negative index tests) in people with pancreatic lesions irrespective of language or publication status or whether the data were collected prospectively or retrospectively.

Two review authors independently searched the references to identify relevant studies and extracted the data. We planned to use the bivariate analysis to calculate the summary sensitivity and specificity with their 95% confidence intervals and the hierarchical summary receiver operating characteristic (HSROC) to compare the tests and assess heterogeneity, but used simpler models (such as univariate random-effects model and univariate fixed-effect model) for combining studies when appropriate because of the sparse data. We were unable to compare the diagnostic performance of the tests using formal statistical methods because of sparse data.

We included 54 studies involving a total of 3,196 participants evaluating the diagnostic accuracy of various index tests. In these 54 studies, eight different target conditions were identified with different final diagnoses constituting benign, precancerous, and cancerous lesions. None of the studies was of high methodological quality. None of the comparisons in which single studies were included was of sufficiently high methodological quality to warrant highlighting of the results. For differentiation of cancerous lesions from benign or precancerous lesions, we identified only one study per index test. The second analysis, of studies differentiating cancerous versus benign lesions, provided three tests in which meta-analysis could be performed. The sensitivities and specificities for diagnosing cancer were: EUS-FNA: sensitivity 0.79 (95% confidence interval (CI) 0.07 to 1.00), specificity 1.00 (95% CI 0.91 to 1.00); EUS: sensitivity 0.95 (95% CI 0.84 to 0.99), specificity 0.53 (95% CI 0.31 to 0.74); PET: sensitivity 0.92 (95% CI 0.80 to 0.97), specificity 0.65 (95% CI 0.39 to 0.84). The third analysis, of studies differentiating precancerous or cancerous lesions from benign lesions, only provided one test (EUS-FNA) in which meta-analysis was performed. EUS-FNA had moderate sensitivity for diagnosing precancerous or cancerous lesions (sensitivity 0.73 (95% CI 0.01 to 1.00) and high specificity 0.94 (95% CI 0.15 to 1.00), the extremely wide confidence intervals reflecting the heterogeneity between the studies). The fourth analysis, of studies differentiating cancerous (invasive carcinoma) from precancerous (dysplasia) provided three tests in which meta-analysis was performed. The sensitivities and specificities for diagnosing invasive carcinoma were: CT: sensitivity 0.72 (95% CI 0.50 to 0.87), specificity 0.92 (95% CI 0.81 to 0.97); EUS: sensitivity 0.78 (95% CI 0.44 to 0.94), specificity 0.91 (95% CI 0.61 to 0.98); EUS-FNA: sensitivity 0.66 (95% CI 0.03 to 0.99), specificity 0.92 (95% CI 0.73 to 0.98). The fifth analysis, of studies differentiating cancerous (high-grade dysplasia or invasive carcinoma) versus precancerous (low- or intermediate-grade dysplasia) provided six tests in which meta-analysis was performed. The sensitivities and specificities for diagnosing cancer (high-grade dysplasia or invasive carcinoma) were: CT: sensitivity 0.87 (95% CI 0.00 to 1.00), specificity 0.96 (95% CI 0.00 to 1.00); EUS: sensitivity 0.86 (95% CI 0.74 to 0.92), specificity 0.91 (95% CI 0.83 to 0.96); EUS-FNA: sensitivity 0.47 (95% CI 0.24 to 0.70), specificity 0.91 (95% CI 0.32 to 1.00); EUS-FNA carcinoembryonic antigen 200 ng/mL: sensitivity 0.58 (95% CI 0.28 to 0.83), specificity 0.51 (95% CI 0.19 to 0.81); MRI: sensitivity 0.69 (95% CI 0.44 to 0.86), specificity 0.93 (95% CI 0.43 to 1.00); PET: sensitivity 0.90 (95% CI 0.79 to 0.96), specificity 0.94 (95% CI 0.81 to 0.99). The sixth analysis, of studies differentiating cancerous (invasive carcinoma) from precancerous (low-grade dysplasia) provided no tests in which meta-analysis was performed. The seventh analysis, of studies differentiating precancerous or cancerous (intermediate- or high-grade dysplasia or invasive carcinoma) from precancerous (low-grade dysplasia) provided two tests in which meta-analysis was performed. The sensitivity and specificity for diagnosing cancer were: CT: sensitivity 0.83 (95% CI 0.68 to 0.92), specificity 0.83 (95% CI 0.64 to 0.93) and MRI: sensitivity 0.80 (95% CI 0.58 to 0.92), specificity 0.81 (95% CI 0.53 to 0.95), respectively. The eighth analysis, of studies differentiating precancerous or cancerous (intermediate- or high-grade dysplasia or invasive carcinoma) from precancerous (low-grade dysplasia) or benign lesions provided no test in which meta-analysis was performed.There were no major alterations in the subgroup analysis of cystic pancreatic focal lesions (42 studies; 2086 participants). None of the included studies evaluated EUS elastography or sequential testing.

We were unable to arrive at any firm conclusions because of the differences in the way that study authors classified focal pancreatic lesions into cancerous, precancerous, and benign lesions; the inclusion of few studies with wide confidence intervals for each comparison; poor methodological quality in the studies; and heterogeneity in the estimates within comparisons.

Elastography is a newer technique for the assessment of tissue elasticity using ultrasound. Cancerous tissue is known to be stiffer (hence, less elastic) than corresponding healthy tissue, and as a result, could be identified in an elasticity-based imaging. Ultrasound elastography has been used in the breast, thyroid, and cervix to differentiate malignant from benign neoplasms and to guide or avoid unnecessary biopsies. In the liver, elastography has enabled a noninvasive and reliable estimate of fibrosis. Endoscopic ultrasound has become a robust diagnostic and therapeutic tool for the management of pancreatic diseases. The addition of elastography to endoscopic ultrasound enabled further characterization of pancreas lesions, and several European and Asian studies have reported encouraging results. The current clinical role of endoscopic ultrasound elastography in the management of pancreas disorders and related literature are reviewed.

Endoscopic ultrasonography (EUS) is well suited for assessment of the pancreas due to its high resolution and the proximity of the transducer to the pancreas, avoiding air in the gut. Evaluation of chronic pancreatitis (CP) was an early target for EUS, initially just for diagnosis but later for therapeutic purposes. The diagnosis of CP is still accomplished using the standard scoring based on nine criteria, all considered to be of equal value. For diagnosis of any CP, at least three or four criteria must be fulfilled, but for diagnosis of severe CP at least six criteria are necessary. The Rosemont classification, more restrictive, aims to standardize the criteria and assigns different values to different features, but requires further validation. EUS-fine needle aspiration (EUS-FNA) is less advisable for diagnosis of diffuse CP due to its potential side effects. Elastography and contrast-enhanced EUS are orientation in differentiating a focal pancreatic mass in a parenchyma with features of CP, but they cannot replace EUS-FNA. The usefulness of EUS-guided celiac block for painful CP is still being debated with regard to the best technique and the indications. EUS-guided drainage of pseudocysts is preferred in non-bulging pseudocysts or in the presence of portal hypertension. EUS-guided drainage of the main pancreatic duct should be reserved for cases in which endoscopic retrograde cholangiopancreatography has failed owing to difficult cannulation of the papilla or difficult endotherapy. It should be performed only by highly skilled endoscopists, due to the high rate of complications.

The lack of accurate markers makes preoperative differentiation between pancreatic cancer and non-malignant head lesions clinically challenging. In this study, we investigated the incidence of benign disease in patients that underwent resection for presumed pancreatic cancer diagnosed by EUS and EUS-guided FNA.

Medical records of consecutive patients who underwent pancreaticoduodenectomy at Duke University were reviewed. Demographics, clinicopathologic characteristics, preoperative imaging, EUS, EUS-guided FNA, and postoperative outcomes were analyzed.

Seven percent of the total 494 patients studied were found to have benign disease on postoperative pathology. Fifty-nine percent of these patients with benign disease underwent preoperative EUS. EUS was positive for a head mass in 70%, demonstrated enlarged lymph nodes in 27%, and showed signs concerning for vascular invasion in 13%. FNA was suspicious or indeterminate for cancer in 63% of patients. Postoperative complications occurred in 47% and one patient died after surgery. The overall pancreatic leak rate was 15%.

Even with aggressive use of preoperative evaluation, there is still a small subset of patients where malignancy cannot be excluded without pancreaticoduodenectomy.

In fecal incontinence the role of elastography has not yet been evaluated. We performed a trial to further characterize the internal and external anal sphincter in patients with fecal incontinence and compared a visual assessment scale with a computerized program for quantifying elastic properties of the anal sphincter.

Fifty consecutive patients with fecal incontinence were studied (n = 31 following lower anterior resection, n = 8 with Crohn's disease, n = 9 following colon surgery, n = 2 others). Elastogram color distribution within the sphincter representing elastic properties was quantified using a visual analog scale and an off-line computerized area calculation program.

The main finding was that the inner anal sphincter (IAS) differed significantly from the external anal sphincter (EAS) with regard to elastogram color distribution. There were no significant correlations with clinical and functional parameters. There was, however, a non-significant increase in the percentage of blue (hard) areas in the IAS in patients neoadjuvantly irradiated for rectal or cervical cancer compared to non-irradiated patients, which was accompanied by a significant decrease in the resting sphincter pressure (p < 0.009).

The IAS, a smooth muscle, and the EAS, a striated muscle, have different elastogram color distributions, probably reflecting their different elastic properties. The absence of significant correlations with the major clinical and functional parameters suggests that in routine clinical practice ultrasound real-time elastography may not yield additional information in patients with fecal incontinence. There may be exceptions, particularly in irradiated patients.

EUS elastography is a newly developed imaging procedure that characterizes the differences of hardness and strain between diseased and normal tissue.

To assess the accuracy of real-time EUS elastography in pancreatic lesions.

Cross-sectional feasibility study.

The study group included, in total, 68 patients with normal pancreas (N = 22), chronic pancreatitis (N = 11), pancreatic adenocarcinoma (N = 32), and pancreatic neuroendocrine tumors (N = 3). A subgroup analysis of 43 cases with focal pancreatic masses was also performed.

A postprocessing software analysis was used to examine the EUS elastography movies by calculating hue histograms of each individual image, data that were further subjected to an extended neural network analysis to differentiate benign from malignant patterns.

To differentiate normal pancreas, chronic pancreatitis, pancreatic cancer, and neuroendocrine tumors.

Based on a cutoff of 175 for the mean hue histogram values recorded on the region of interest, the sensitivity, specificity, and accuracy of differentiation of benign and malignant masses were 91.4%, 87.9%, and 89.7%, respectively. The positive and negative predictive values were 88.9% and 90.6%, respectively. Multilayer perceptron neural networks with both one and two hidden layers of neurons (3-layer perceptron and 4-layer perceptron) were trained to learn how to classify cases as benign or malignant, and yielded an excellent testing performance of 95% on average, together with a high training performance that equaled 97% on average.

A lack of the surgical standard in all cases.

EUS elastography is a promising method that allows characterization and differentiation of normal pancreas, chronic pancreatitis, and pancreatic cancer. The currently developed methodology, based on artificial neural network processing of EUS elastography digitalized movies, enabled an optimal prediction of the types of pancreatic lesions. Future multicentric, randomized studies with adequate power will have to establish the clinical impact of this procedure for the differential diagnosis of focal pancreatic masses.