Julio Iglesias-Garcia

Feasibility and yield of a new EUS histology needle: results from a multicenter, pooled, cohort study

BACKGROUND EUS-guided FNA is an efficacious technique for sampling intraintestinal and extraintestinal mass lesions. However, cytology has limitations to its final yield and accuracy, which may be overcome if histological specimens are provided to the pathologist. OBJECTIVE To evaluate feasibility, yield, and diagnostic accuracy of a newly developed 19-gauge, fine-needle biopsy (FNB) device. DESIGN Multicenter, pooled, cohort study. SETTING Five medical centers. PATIENTS This study involved 109 consecutive patients with 114 intraintestinal or extraintestinal mass lesions and/or peri-intestinal lymph nodes. INTERVENTION EUS-guided FNB (EUS-FNB) with a newly developed, 19-gauge, FNB device. MAIN OUTCOME MEASUREMENTS Percentage of cases in which pathologists classified the sample quality as optimal for histological evaluation and the overall diagnostic accuracy compared with a composite criterion-standard diagnosis. RESULTS We evaluated 114 lesions (mean [± standard deviation] size 35.1 ± 18.7 mm; 84 malignant [73.7%] and 30 [26.3%] benign). EUS-FNB was technically feasible in 112 lesions (98.24%). Sample quality was adequate for full histological assessment in 102 lesions (89.47%). In 98 cases (85.96%), diagnosis proved to be correct according to criterion-standard diagnosis. Sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy for diagnosis of malignancy were 90.2%, 100%, 100%, 78.9%, and 92.9%, respectively. LIMITATIONS Use of a surrogate criterion-standard diagnosis, including clinical follow-up when no surgical specimens were available, mainly in benign diagnoses. CONCLUSION Performing an EUS-FNB with a new 19-gauge histology needle is feasible for histopathology diagnosis of intraintestinal and extraintestinal mass lesions, offering the possibility of obtaining a core sample for histological evaluation in the majority of cases, with an overall diagnostic accuracy of over 85%.

Influence of On-Site Cytopathology Evaluation on the Diagnostic Accuracy of Endoscopic Ultrasound-Guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Masses

OBJECTIVES:The aim of this study was to evaluate the influence of on-site cytopathological evaluation on the diagnostic yield of endoscopic ultrasound (EUS)-guided fine needle aspiration (FNA) for the differential diagnosis of solid pancreatic masses in an unselected series of consecutive patients.METHODS:Patients undergoing EUS-guided FNA of solid pancreatic lesions over a 2-year study period were included. Samples were either evaluated on site by a cytopathologist or processed by the endoscopist and sent to the pathology department for evaluation. Diagnostic accuracy for malignancy, number of needle passes, adequate-specimen collection rate, cytological diagnosis, and final diagnosis, and complication rate according to the presence or absence of on-site cytopathologist were evaluated.RESULTS:A total of 182 patients were included. An on-site cytopathologist was available in 95 cases (52.2%). There was no difference between groups in terms of age, sex, location, and size of the lesions. A significantly higher number of needle passes was performed when an on-site cytopathologist was not available (3.5±1.0 vs. 2.0±0.7; P<0.001). The presence of an on-site cytopathologist was associated with a significantly lower number of inadequate samples (1.0 vs. 12.6%, P=0.002), and a significantly higher diagnostic sensitivity (96.2 vs. 78.2%; P=0.002) and overall accuracy (96.8 vs. 86.2%; P=0.013) for malignancy. Three patients developed complications (two acute pancreatitis, one local bleeding), all of them belonging to the group without on-site cytopathology.CONCLUSIONS:On-site cytopathological evaluation improves the diagnostic yield of EUS-guided FNA for the cytological diagnosis of solid pancreatic masses. This is associated with a significantly lower number of inadequate samples and a lower number of needle passes.

Accuracy of endoscopic ultrasound elastography used for differential diagnosis of focal pancreatic masses: a multicenter study.

BACKGROUND AND STUDY AIMS Endoscopic ultrasound (EUS) elastography represents a new imaging procedure that might characterize the differences of hardness and strain between diseased tissue and normal tissue. The aim of this study was to assess the efficiency of EUS elastography for the differentiation of focal masses in chronic pancreatitis and pancreatic cancer. PATIENTS AND METHODS The study group comprised 258 patients with focal pancreatic masses included prospectively at 13 participating centers. Qualitative analysis of the diagnoses made by two expert doctors using all recorded video clips was performed in order to test the interobserver variability. A post-processing software analysis was used to examine the EUS elastography videos by calculating average-hue histograms of individual elastography images. The quantitative information was used to calculate intra-observer variability and the accuracy of the method. RESULTS Qualitative analysis of the recorded videos revealed a kappa value of 0.72. Intra-observer variability analysis revealed that the single measure intraclass correlation ranged between 0.86 and 0.94. The average-hue histogram analysis of the data indicated a sensitivity of 93.4 %, a specificity of 66.0 %, a positive predictive value of 92.5 %, a negative predictive value of 68.9 %, and an overall accuracy of 85.4 %, based on a cut-off value of 175. Area under the receiver operating characteristic curve (AUROC) was 0.854 ( P < 0.0001) with a confidence interval of 0.804 - 0.894. CONCLUSION The value of quantitative analysis of EUS elastography recordings was proven by good reproducibility of the videos, as well as good parameters of the AUROC analysis. (Clinical Trials.gov identifier: CT00909103).

EUS elastography for the characterization of solid pancreatic masses

BACKGROUND Differential diagnosis of solid pancreatic masses remains a challenge. EUS elastography, by analyzing tissue stiffness of the mass, may be of help in this setting. OBJECTIVE To evaluate the different elastographic patterns of solid pancreatic masses and the diagnostic accuracy of EUS elastography for malignancy. DESIGN Prospective, consecutive, descriptive study with a second blind evaluation of elastographic patterns for concordance analysis and use of a well-defined reference method for calculation of diagnostic accuracy. PATIENTS This study involved 130 consecutive patients with solid pancreatic masses and 20 controls with normal pancreases. INTERVENTION EUS elastography was performed by using a linear Pentax echoendoscope and Hitachi EUB-8500 US. MAIN OUTCOME MEASUREMENTS Elastographic patterns of solid pancreatic masses and accuracy of the technique for malignancy. RESULTS Mean (SD) size of the masses was 30.9 (12.5) mm. The final diagnosis was malignant tumor in 78 patients, inflammatory mass in 42 patients, and neuroendocrine tumor in 10 patients. Four elastographic patterns were described, with a high concordance among 2 blinded investigators. A green-predominant pattern, either homogeneous or heterogeneous, excluded malignancy with a high accuracy. On the contrary, a blue-predominant pattern, either homogeneous or heterogeneous, supported the diagnosis of malignant tumor. Sensitivity, specificity, positive and negative predictive values, and overall accuracy of EUS elastography for diagnosis of malignancy were 100%, 85.5%, 90.7%, 100%, and 94.0%, respectively. LIMITATION Single-center study. CONCLUSION EUS elastography is a useful tool for differential diagnosis of solid pancreatic masses. It provides specific patterns supporting the benign or malignant nature of the disease.

Initial experience with EUS-guided cholangiopancreatography for biliary and pancreatic duct drainage: a Spanish national survey.

BACKGROUND EUS-guided cholangiopancreatography (ESCP) allows transmural access to biliopancreatic ducts when ERCP fails. Data regarding technical details, safety, and outcomes of ESCP are still unknown. OBJECTIVE To evaluate outcomes of ESCP in community and referral centers at the initial development phase of this procedure, to identify the ESCP stages with higher risk of failure, and to evaluate the influence on outcomes of factors related to the endoscopist. DESIGN Multicenter retrospective study. SETTING Public health system hospitals with experience in ESCP in Spain. PATIENTS A total of 125 patients underwent ESCP in 19 hospitals, with an experience of <20 procedures. INTERVENTION ESCP. MAIN OUTCOME MEASUREMENTS Technical success and complication rates in the initial phase of implantation of ESCP are described. The influence of technical characteristics and endoscopist features on outcomes was analyzed. RESULTS A total of 125 patients from 19 hospitals were included. Biliary ESCP was performed in 106 patients and pancreatic ESCP was performed in 19. Technical success was achieved in 84 patients (67.2%) followed by clinical success in 79 (63.2%). Complications occurred in 29 patients (23.2%). Unsuccessful manipulation of the guidewire was responsible for 68.2% of technical failures, and 58.6% of complications were related to problems with the transmural fistula. LIMITATIONS Retrospective study. CONCLUSION Outcomes of ESCP during its implantation stage reached a technical success rate of 67.2%, with a complication rate of 23.2%. Intraductal manipulation of the guidewire seems to be the most difficult stage of the procedure.

Oral Pancreatic Enzyme Substitution Therapy in Chronic Pancreatitis: Is Clinical Response an Appropriate Marker for Evaluation of Therapeutic Efficacy?

CONTEXT Malnutrition secondary to pancreatic exocrine insufficiency plays a prognostic role in chronic pancreatitis. Enzyme substitution therapy is generally prescribed to avoid diarrhea and weight loss, although it is unknown whether this is associated with normal absorption of nutrients and a normal nutritional status. OBJECTIVE We aimed to evaluate whether an adequate clinical response to enzyme therapy can be used to predict a normal nutritional status in patients with chronic pancreatitis. PATIENTS Thirty-one consecutive patients (25 males, 6 females; mean age 52 years,) with severe chronic pancreatitis and steatorrhea were enrolled in the study. INTERVENTION Enzyme substitution therapy was indicated in cases with severe steatorrhea (more than 15 g/day), diarrhea and/or weight loss. Therapy was optimized in individual patients to obtain complete symptom relief. MAIN OUTCOME MEASURE A nutritional evaluation including body mass index and serum levels of retinol-binding protein, prealbumin and transferrin was carried out. RESULTS Ten out of ten patients with asymptomatic steatorrhea, who did not fulfill the criteria for enzyme substitution therapy, and 11 out of 21 patients (52.4%) with symptomatic or more severe steatorrhea, who were under enzyme substitution therapy, showed a deficient nutritional status. CONCLUSIONS An appropriate clinical response to enzyme substitution therapy does not allow the prediction of a normal nutritional status in patients with chronic pancreatitis.

Quantitative elastography associated with endoscopic ultrasound for the diagnosis of chronic pancreatitis.

BACKGROUND AND STUDY AIMS Endoscopic ultrasonography (EUS) has become the method of choice for the diagnosis of chronic pancreatitis in clinical practice. However, the criteria allowing the specific diagnosis of the disease, mainly at non-advanced stages, are still under debate. Analysis of tissue stiffness by quantitative EUS-elastography may provide additional relevant information in this setting. The aim of this study was to evaluate the information provided by quantitative EUS-elastography for the diagnosis of chronic pancreatitis. PATIENTS AND METHODS A prospective, consecutive, 1-year study was designed, and included patients who underwent EUS for epigastric pain syndrome or known chronic pancreatitis. EUS-elastography was performed using radial Pentax EUS and Hitachi EUB900. The strain ratio was measured in the head, body, and tail of the pancreas, and the elastographic result was the mean of these three values. EUS criteria of chronic pancreatitis and the Rosemont classification were also evaluated. Data were analyzed by analysis of variance and linear regression; diagnostic accuracy was based on the receiver operating characteristic (ROC) curve analysis. RESULTS A total of 191 patients (mean age 52 years, range 21 - 85; 103 male) were included; 92 (48.2 %) of them were finally diagnosed with chronic pancreatitis. A highly significant direct linear correlation was found between the number of EUS criteria of chronic pancreatitis and the strain ratio (r = 0.813; P < 0.0001). The area under the ROC curve was 0.949 (95 % confidence interval 0.916 - 0.982) and the accuracy of EUS-elastography for diagnosing chronic pancreatitis was 91.1 % (cut-off strain ratio of 2.25). The strain ratio varied significantly in different Rosemont classification groups (P < 0.001). CONCLUSIONS EUS-elastography was an accurate tool for the diagnosis of chronic pancreatitis and provided relevant and objective information to support EUS findings.

The Spanish Pancreatic Club's recommendations for the diagnosis and treatment of chronic pancreatitis: part 2 (treatment).

Chronic pancreatitis (CP) is a complex disease with a wide range of clinical manifestations. This range comprises from asymptomatic patients to patients with disabling symptoms or complications. The management of CP is frequently different between geographic areas and even medical centers. This is due to the paucity of high quality studies and clinical practice guidelines regarding its diagnosis and treatment. The aim of the Spanish Pancreatic Club was to give current evidence-based recommendations for the management of CP. Two coordinators chose a multidisciplinary panel of 24 experts on this disease. These experts were selected according to clinical and research experience in CP. A list of questions was made and two experts reviewed each question. A draft was later produced and discussed with the entire panel of experts in a face-to-face meeting. The level of evidence was based on the ratings given by the Oxford Centre for Evidence-Based Medicine. In the second part of the consensus, recommendations were given regarding the management of pain, pseudocysts, duodenal and biliary stenosis, pancreatic fistula and ascites, left portal hypertension, diabetes mellitus, exocrine pancreatic insufficiency, and nutritional support in CP.

Indications, results, and clinical impact of endoscopic ultrasound (EUS)-guided sampling in gastroenterology: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline – Updated January 2017

For pancreatic solid lesions, ESGE recommends performing endoscopic ultrasound (EUS)-guided sampling as first-line procedure when a pathological diagnosis is required. Alternatively, percutaneous sampling may be considered in metastatic disease.Strong recommendation, moderate quality evidence.In the case of negative or inconclusive results and a high degree of suspicion of malignant disease, ESGE suggests re-evaluating the pathology slides, repeating EUS-guided sampling, or surgery.Weak recommendation, low quality evidence.In patients with chronic pancreatitis associated with a pancreatic mass, EUS-guided sampling results that do not confirm cancer should be interpreted with caution.Strong recommendation, low quality evidence.For pancreatic cystic lesions (PCLs), ESGE recommends EUS-guided sampling for biochemical analyses plus cytopathological examination if a precise diagnosis may change patient management, except for lesions ≤ 10 mm in diameter with no high risk stigmata. If the volume of PCL aspirate is small, it is recommended that carcinoembryonic antigen (CEA) level determination be done as the first analysis.Strong recommendation, low quality evidence.For esophageal cancer, ESGE suggests performing EUS-guided sampling for the assessment of regional lymph nodes (LNs) in T1 (and, depending on local treatment policy, T2) adenocarcinoma and of lesions suspicious for metastasis such as distant LNs, left liver lobe lesions, and suspected peritoneal carcinomatosis.Weak recommendation, low quality evidence.For lymphadenopathy of unknown origin, ESGE recommends performing EUS-guided (or alternatively endobronchial ultrasound [EBUS]-guided) sampling if the pathological result is likely to affect patient management and no superficial lymphadenopathy is easily accessible.Strong recommendation, moderate quality evidence.In the case of solid liver masses suspicious for metastasis, ESGE suggests performing EUS-guided sampling if the pathological result is likely to affect patient management, and (i) the lesion is poorly accessible/not detected at percutaneous imaging, or (ii) a sample obtained via the percutaneous route repeatedly yielded an inconclusive result.Weak recommendation, low quality evidence.

Smoking as a risk factor for complications in chronic pancreatitis.

Objectives Several recent studies have demonstrated the association between smoking and chronic pancreatitis (CP). However, less is known about the role of smoking in the development of CP-related complications. Our aim was to investigate the impact of smoking and alcohol consumption on age of onset and complications at CP diagnosis. Methods A cross-sectional case-case study was performed within a prospectively collected cohort of patients with CP. Alcohol consumption and smoking habits were assessed using a standardized questionnaire. Morphologic severity was defined based on endoscopic ultrasound criteria for CP and classified as mild (3–4 criteria), moderate (5–6 criteria), and severe (≥7 criteria or calcifications). Pancreatic exocrine insufficiency (PEI) was diagnosed using the 13C-mixed triglyceride breath test. Odds ratios (OR) with 95% confidence intervals (CI) for CP-related complications were calculated using a case-case design. Results A total of 241 patients were included. Smoking was associated with PEI (OR [95% CI], 2.4 [1.17–5.16]), calcifications (OR [95% CI], 2.33 [1.10–4.95]), and severe morphologic changes (OR [95% CI], 3.41 [1.31–8.85]) but not with pseudocysts or diabetes. Neither smoking nor alcohol consumption was associated with age of onset. Conclusions Tobacco, but not alcohol, is associated with PEI, calcifications, and severe morphologic (≥7 criteria or calcifications) CP at diagnosis. Smoking cessation should be encouraged in patients with CP.