Pancreatic cancer screening in high-risk individuals.

The incidence of pancreatic cancer is increasing, although globally it represents less than 3% of all cancers. Despite advances in medical and surgical management, survival rates have not significantly improved in recent years. Consequently, pancreatic cancer, though relatively uncommon, is the third leading cause of cancer-related deaths. This is primarily due to the disease´s late detection. Symptoms appear late and are nonspecific, and over 80% of cases are diagnosed at an advanced stage and unsuitable for curative surgery, resulting in a five-year survival rate below 10%. However, the exceptional cases that are diagnosed early show five-year survival rates exceeding 80%. Therefore, one of the keys to improving pancreatic cancer prognosis lies in early detection, making screening in high-risk individuals a potentially crucial strategy.

Endoscopic Ultrasound-Guided Tissue Sampling for the Cytohistological Diagnosis of Focal Liver Lesions.

BACKGROUND: Focal liver lesions (FLL) often require cytohistological evaluation. Endoscopic Ultrasound (EUS)-guided tissue acquisition (EUS-TA) is highly accurate in diagnosing pancreatic and gastrointestinal malignancies. The aim of our study was to evaluate the role of EUS-TA in the characterization of FLL. METHODS: A retrospective analysis of a prospective database of patients who underwent EUS-TA for the evaluation of FLL. Diagnostic yield, adverse events and factors associated with diagnostic yield were evaluated as endpoints. The effect of variables such as needle size, lesion size, rapid on-site evaluation (ROSE) and the use of cytological or histological needles were analyzed. RESULTS: A total of 114 cases were included (mean age 68.05 ± 11.35 years, 64 male). A correct diagnosis was made using EUS-TA in 100 of the 114 cases (diagnostic yield of 88%). The EUS-TA of additional extrahepatic lesions during the same EUS procedure increased the diagnostic yield to 94%. No adverse events were reported. Multivariate analysis did not identify any factor influencing the diagnostic yield. CONCLUSIONS: EUS-TA is a highly accurate and safe technique for the differential diagnosis of FLL and could be considered as the primary approach in this setting.

Endoscopic management of pancreatic collections. Endoscopic Ultrasound Group, Spanish Society of Digestive Endoscopy (GSEED-USE) Clinical Guidelines.

Acute pancreatitis is associated with significant morbidity and mortality. It can develop complications such as fluid collections and necrosis. Infection of necrosis occurs in about 20-40 % of patients with severe acute pancreatitis, and is associated with organ failure and worse prognosis. In the past few years the treatment of pancreatic collections has shifted from open surgery to minimally invasive techniques such as endoscopic ultrasound-guided drainage. These guidelines from a selection of experts among the Endoscopic Ultrasound Group, Spanish Society of Gastrointestinal Endoscopy (GSEED-USE) are intended to provide advice on the management of pancreatic collections based on a thorough review of the available scientific evidence. It also reflects the experience and clinical practice of the authors, who are advanced endoscopists or clinical pancreatologists with extensive experience in managing patients with acute pancreatitis.

Quality of Tissue Samples Obtained by Endoscopic Ultrasound-Guided Liver Biopsy: A Randomized, Controlled Clinical Trial.

INTRODUCTION: Liver biopsy (LB) remains essential for the diagnosis and staging of parenchymal liver diseases. Endoscopic ultrasound-guided LB (EUS-LB) has emerged as an attractive alternative to percutaneous and transjugular routes. We aimed at comparing the adequacy of samples obtained by EUS-LB with percutaneous LB. METHODS: A single-center, randomized, controlled clinical trial was designed. Patients undergoing LB were randomly assigned to EUS-LB or percutaneous LB groups. EUS-LB was performed with a 19-gauge Franseen core needle through a transduodenal and transgastric route. Percutaneous LB was performed with a 16-gauge Tru-Cut needle. The main outcome was the percentage of adequate samples obtained. Secondary outcomes were the percentage of accurate histologic diagnosis, number of complete portal tracts (CPT), total and longest specimen length (TSL and LSL), sample fragmentation, adverse events, and patients' satisfaction. An adequate specimen was defined as TSL ≥20 mm and including ≥11 CPT. RESULTS: Ninety patients were randomized (44 to EUS-LB and 46 to percutaneous LB) and included in the analysis. The percentage of adequate tissue samples was 32.6% and 70.4% for percutaneous LB and EUS-LB, respectively ( P < 0.001). A final histologic diagnosis was provided in all cases but one. TSL was longer after EUS-LB (23.5 vs 17.5 mm, P = 0.01), whereas the number of CPT was similar in both groups. Sample fragmentation occurred more often after EUS-LB ( P < 0.001). No differences in adverse events were found. Satisfaction reported with both procedures was high. DISCUSSION: EUS-LB is safe and accurate and may be considered an alternative to percutaneous LB for the evaluation of parenchymal liver diseases.

Endoscopic Ultrasound (EUS) Guided Elastography.

Endoscopic ultrasound (EUS) is an essential technique for the management of several diseases. Over the years, new technologies have been developed to improve and overcome certain limitations related to EUS-guided tissue acquisition. Among these new methods, EUS-guided elastography, which is a real-time method for the evaluation of tissue stiffness, has arisen as one of the most widely recognized and available. At present, there are available two different systems to perform an elastographic evaluation: strain elastography and shear wave elastography. Strain elastography is based on the knowledge that certain diseases lead to a change in tissue hardness while shear wave elastography monitored shear-wave propagation and measures its velocity. EUS-guided elastography has shown in several studies high accuracy in differentiating benign from malignant lesions from many different locations, mostly in the pancreas and lymph nodes. Therefore, nowadays, there are well-established indications for this technology, mainly for supporting the management of pancreatic diseases (diagnosis of chronic pancreatitis and differential diagnosis of solid pancreatic tumors) and characterization of different diseases. However, there are more data on new potential indications for the near future. In this review, we will present the theoretical bases of this technology and we will discuss the scientific evidence to support its use.

Endoscopic ultrasonography: Enhancing diagnostic accuracy.

Endoscopic ultrasound (EUS) is an essential technique for the management of several diseases. Over the years, new technologies have been developed because to improve and overcome certain limitations related to EUS guided tissue acquisition. Among these new methods, EUS guided elastography and contrast enhanced EUS has arisen as the most widely recognized and available. We will review in this manuscript the different techniques of elastography and contrast enhancement. Nowadays, there are well establish indications for advance imaging, mainly for supporting the management of pancreatic diseases (diagnosis of chronic pancreatitis and differential diagnosis of solid and cystic pancreatic tumors) and characterization of lymph nodes. However, there are more data on new potential indications for the near future.

Pancreatic Elastography Predicts Endoscopic Secretin-Pancreatic Function Test Result in Patients With Early Changes of Chronic Pancreatitis: A Prospective, Cross-Sectional, Observational Study.

INTRODUCTION: The endoscopic pancreatic function test (ePFT) has been proposed for the evaluation of patients with suspected early chronic pancreatitis (CP) in the appropriate clinical context, but the cost and duration of the test limit its clinical applicability. Pancreatic secretion decreases as pancreatic fibrosis develops in CP. Pancreatic fibrosis can be quantified by endoscopic ultrasound-elastography (EUS-E). We aim at evaluating whether EUS-E correlates with and could replace ePFT for the evaluation of patients with suspected CP. METHODS: A prospective, cross-sectional, and observational study of patients with clinical suspicion of CP and inconclusive EUS findings was conducted. EUS-E and ePFT were performed. Diagnosis of CP was supported if the ePFT result (bicarbonate peak) was abnormally low (<80 mEq/L). Correlation between EUS-E (strain ratio [SR]) and ePFT results was analyzed by linear regression. Diagnostic accuracy of EUS-E for CP was calculated using ePFT as a reference method. RESULTS: Sixty-one patients were included and analyzed. The mean peak bicarbonate concentration at the ePFT was 63.8 ± 23.6 mEq/L, and it was abnormally low in 50 patients (82.0%). The mean SR was 3.85 ± 1.24. Correlation between SR and bicarbonate secretion was highly significant ( r = 0.715, P < 0.0001). Diagnostic accuracy of EUS-E for CP was 93.4%. DISCUSSION: The degree of pancreatic fibrosis as evaluated by EUS-E correlates significantly with the secretin-stimulated pancreatic secretion of bicarbonate in patients with clinical suspicion of CP and inconclusive EUS findings of the disease. EUS-E could replace ePFT for the evaluation of these patients in clinical practice.

Emergent endoscopic ultrasound-guided cholecystoduodenostomy does not prevent R0 resection in a pancreaticoduodenectomy for pancreatic cancer.

Endoscopic ultrasound-guided biliary drainage, mainly choledochoduodenostomy, is commonly used as rescue therapy after Endoscopic Retrograde Cholangiopancreatography (ERCP) in malignant distal biliary obstruction due to un-resectable pancreatic cancer. An alternative when the cystic duct is patent and choledochoduodenostomy is not feasible is performing an Endoscopic Ultrasound-gallbladder drainage. The advent of the Lumen Apposing Metal Stents (LAMS) has shortened and simplified this procedure. However, many concerns exist about the performance of these procedures with metal stents preoperatively in resectable tumors. The evidence about Endoscopic Ultrasound-gallbladder drainage before surgery of pancreatic cancer is scarce. An emergent Endoscopic Ultrasound (EUS)-gallbladder drainage (cholecysto-duodenostomy) was performed due to acute cholangitis in the setting of a resectable pancreatic tumor. Surgery after neoadjuvant therapy was done three months later. A complete resection of tumor was feasible. EUS-guided gallbladder drainage using LAMS does not preclude performing a complete resection of a pancreatic head tumor.

Endoscopic drainage with local infusion of antibiotics to avoid necrosectomy of infected walled-off necrosis.

BACKGROUND: Current treatment of infected pancreatic necrosis (IPN) follows a step-up approach. Our group designed a step-up protocol that associates endoscopic drainage with local infusion of antibiotics through transmural nasocystic catheter. Aim of our study was to evaluate our step-up protocol for IPN in terms of proportion of patients avoiding necrosectomy. METHODS: Retrospective analysis of patients admitted with acute pancreatitis (AP) between January 2015 and December 2018. The number of patients who responded to each therapeutic step were analysed: step 1, systemic antibiotics; step 2, endoscopic transmural drainage and local infusion of antibiotics; step 3, endoscopic necrosectomy. RESULTS: 1158 patients with AP were included. 110 patients (8.4%) suffered from necrotising pancreatitis; 48 of them had IPN (42.6% of necrotising pancreatitis) and were treated with systemic antibiotics. Nineteen patients (39.6% of IPN) responded and did not required any invasive therapy. Six patients with IPN on systemic antibiotics died within the first 4 weeks of disease before step 2 could be applied. Urgent surgical necrosectomy in the first 4 weeks was performed in three additional patients. Endoscopic drainage and local antibiotic therapy was performed in the remaining 20 patients; 9 (45% of them) did well and 9 patients underwent necrosectomy (18.7% of IPN). Two patients died on drainage. Overall mortality of the total cohort of AP was 2.53% CONCLUSIONS: Addition of local infusion of antibiotics to endoscopic drainage avoids the need of necrosectomy in half of patients with IPN not responding to systemic antibiotics.

Endoscopic ultrasound-based multimodal evaluation of the pancreas in patients with suspected early chronic pancreatitis.

BACKGROUND: Diagnosis of early chronic pancreatitis is a clinical challenge and hindered by the lack of a gold standard. Endoscopic ultrasound (EUS) and the endoscopic pancreatic function test (ePFT) are the most sensitive morphological and functional methods in this setting. EUS-elastography allows for the quantification (strain ratio) of pancreatic fibrosis, and the dynamic evaluation of the main pancreatic duct compliance provides additional information. We developed a multimodal EUS-based approach for the evaluation of the pancreas by integrating these four methods in a single procedure. OBJECTIVE: We aim to describe morphological and functional pancreatic abnormalities in patients with clinical suspicion of chronic pancreatitis and inconclusive EUS findings by using the multimodal EUS-based approach. METHODS: This was a prospective, cross-sectional, observational study of patients with clinically suspected chronic pancreatitis and indeterminate EUS criteria of the disease. EUS criteria of chronic pancreatitis, quantitative pancreatic elastography, ePFT and compliance of the main pancreatic duct were evaluated in a single procedure. RESULTS: In total, 53 patients with 3-4 EUS criteria of chronic pancreatitis were included (mean age 39.7 years, 29 male). Strain ratio was abnormally high in all patients. Peak bicarbonate concentration was decreased in 43 patients (81.1%) and the main pancreatic duct compliance was reduced in 41 patients (77.3%). Some 34 patients (64.1%) had abnormal results at EUS, elastography, ePFT and compliance of the main pancreatic duct. CONCLUSIONS: A multimodal EUS-based test for the morphological and functional evaluation of the pancreas is presented, which allows detecting mild pancreatic abnormalities in patients with suspected early chronic pancreatitis. The presence of abnormal morphological and functional evaluation of the pancreas could support the clinical suspicion of early chronic pancreatitis in the appropriate clinical setting.

Development of a new risk score for invasive cancer in branch-duct intraductal papillary mucinous neoplasms according to morphological characterization by EUS.

BACKGROUND AND OBJECTIVE: The management of branch-duct intraductal papillary mucinous neoplasms (BD-IPMNs) is determined by a number of guidelines. The current weight of risk factors by EUS predicting invasive cancer is unknown. The aim of this study is to develop a risk score for early prediction of invasive cancer according to morphological characterization by EUS in a surgical cohort. MATERIALS AND METHODS: This is an observational, multicenter retrospective study. All consecutive patients with a histologically proven BD-IPMN who underwent previous EUS between 2005 and 2017 were included. Morphological features by EUS were evaluated. A score using a logistic regression model was performed to assess the risk of invasive cancer. RESULTS: Of 335 patients who underwent pancreatic surgery, 131 (median age: 66 years, 50.4% - male) were included. By multivariable analysis, lymph nodes (odds ratio [OR]: 17.7 [confidence interval (CI) 95%: 2.8-112.6], P = 0.002, 4 points), main pancreatic duct ≥10 mm (OR: 8.6 [CI 95%: 1.9-39.5], P = 0.006, 2 points), abrupt change of pancreatic duct (OR: 5.5 [CI 95%: 1.4-22.2], P = 0.016, 1.5 points), and solid component (OR: 4.2 [CI 95%: 1.3-13.6], P = 0.017, 1 point) were independent factors associated with invasive cancer and included in the model. The following categories of the score (0-8.5 points) - A (0-1), B (1.5-3), C (3.5-5), and D (5.5-8.5 points) - presented a positive predictive value of 8.5%, 38.9%, 62.5%, and 100%, respectively. The area under the curve was 0.857 (P < 0.001), with an overall sensitivity and specificity of 84% and 70% in the internal validation of the score. CONCLUSION: This EUS predictive score for invasive cancer in BD-IPMN has a high accuracy and could be an additional tool to consider in patient management.

Dietary Fat Patterns and Outcomes in Acute Pancreatitis in Spain.

Background/Objective: Evidence from basic and clinical studies suggests that unsaturated fatty acids (UFAs) might be relevant mediators of the development of complications in acute pancreatitis (AP). Objective: The aim of this study was to analyze outcomes in patients with AP from regions in Spain with different patterns of dietary fat intake. Materials and Methods: A retrospective analysis was performed with data from 1,655 patients with AP from a Spanish prospective cohort study and regional nutritional data from a Spanish cross-sectional study. Nutritional data considered in the study concern the total lipid consumption, detailing total saturated fatty acids, UFAs and monounsaturated fatty acids (MUFAs) consumption derived from regional data and not from the patient prospective cohort. Two multivariable analysis models were used: (1) a model with the Charlson comorbidity index, sex, alcoholic etiology, and recurrent AP; (2) a model that included these variables plus obesity. Results: In multivariable analysis, patients from regions with high UFA intake had a significantly increased frequency of local complications, persistent organ failure (POF), mortality, and moderate-to-severe disease in the model without obesity and a higher frequency of POF in the model with obesity. Patients from regions with high MUFA intake had significantly more local complications and moderate-to-severe disease; this significance remained for moderate-to-severe disease when obesity was added to the model. Conclusions: Differences in dietary fat patterns could be associated with different outcomes in AP, and dietary fat patterns may be a pre-morbid factor that determines the severity of AP. UFAs, and particulary MUFAs, may influence the pathogenesis of the severity of AP.

Differential diagnosis of solid pancreatic masses.

Solid pancreatic lesions include mainly adenocarcinoma, neuroendocrine tumors pancreatic cystic neoplasms with solid component, solid pseudopapillary tumor, pancreatoblastoma, pancreatic lymphoma, and pancreatic metastasis. The most frequent pancreatic lesion is the adenocarcinoma, representing between 70% and 95% of all solid pancreatic neoplasm. The diagnosis of these lesions can be a challenge and currently, there are different imaging techniques such as CT scan, EUS and MRI with high sensitivity and specificity. The most widely used technique for the initial evaluation is the CT scan with a sensitivity between 76% and 92% for the diagnosis of pancreatic cancer. The EUS has a sensitivity for the detection of pancreatic lesions of around 98% and is accepted to be the most sensitive technique for the detection of small pancreatic tumors (<2 cm). The MRI, with a very high soft-tissue contrast resolution, provides an accuracy in the detection and staging of adenocarcinoma of 90-100%. A multimodality approach is usually necessary in patients with clinical suspicion of pancreatic lesion. The EUS is required for the local evaluation of the relation of the lesion with vessels and for tissue acquisition and the CT scan and/or MRI is usually required for the local and distance staging in case of pancreatic cancer. The purpose of this review is to provide an overview of solid pancreatic lesions and the role of the different imaging techniques in their evaluation.

An international, multi-institution survey of the use of EUS in the diagnosis of pancreatic cystic lesions.

BACKGROUND AND OBJECTIVES: Currently, pancreatic cystic lesions (PCLs) are recognized with increasing frequency and have become a more common finding in clinical practice. EUS is challenging in the diagnosis of PCLs and evidence-based decisions are lacking in its application. This study aimed to develop strong recommendations for the use of EUS in the diagnosis of PCLs, based on the experience of experts in the field. METHODS: A survey regarding the practice of EUS in the evaluation of PCLs was drafted by the committee member of the International Society of EUS Task Force (ISEUS-TF). It was disseminated to experts of EUS who were also members of the ISEUS-TF. In some cases, percentage agreement with some statements was calculated; in others, the options with the greatest numbers of responses were summarized. RESULTS: Fifteen questions were extracted and disseminated among 60 experts for the survey. Fifty-three experts completed the survey within the specified time frame. The average volume of EUS cases at the experts' institutions is 988.5 cases per year. CONCLUSION: Despite the limitations of EUS alone in the morphologic diagnosis of PCLs, the results of the survey indicate that EUS-guided fine-needle aspiration is widely expected to become a more valuable method.

Exocrine Pancreatic Insufficiency Following Acute Pancreatitis: Systematic Review and Meta-Analysis.

BACKGROUND/OBJECTIVES: The epidemiology of exocrine pancreatic insufficiency (EPI) after acute pancreatitis (AP) is uncertain. We sought to determine the prevalence, progression, etiology and pancreatic enzyme replacement therapy (PERT) requirements for EPI during follow-up of AP by systematic review and meta-analysis. METHODS: Scopus, Medline and Embase were searched for prospective observational studies or randomized clinical trials (RCTs) of PERT reporting EPI during the first admission (between the start of oral refeeding and before discharge) or follow-up (≥ 1 month of discharge) for AP in adults. EPI was diagnosed by direct and/or indirect laboratory exocrine pancreatic function tests. RESULTS: Quantitative data were analyzed from 370 patients studied during admission (10 studies) and 1795 patients during follow-up (39 studies). The pooled prevalence of EPI during admission was 62% (95% confidence interval: 39-82%), decreasing significantly during follow-up to 35% (27-43%; risk difference: - 0.34, - 0.53 to - 0.14). There was a two-fold increase in the prevalence of EPI with severe compared with mild AP, and it was higher in patients with pancreatic necrosis and those with an alcohol etiology. The prevalence decreased during recovery, but persisted in a third of patients. There was no statistically significant difference between EPI and new-onset pre-diabetes/diabetes (risk difference: 0.8, 0.7-1.1, P = 0.33) in studies reporting both. Sensitivity analysis showed fecal elastase-1 assay detected significantly fewer patients with EPI than other tests. CONCLUSIONS: The prevalence of EPI during admission and follow-up is substantial in patients with a first attack of AP. Unanswered questions remain about the way this is managed, and further RCTs are indicated.

Pancreatic exocrine insufficiency and cardiovascular risk in patients with chronic pancreatitis: A prospective, longitudinal cohort study.

BACKGROUND AND AIM: Previous studies have suggested that chronic pancreatitis (CP) is associated with increased risk of cardiovascular (CV) disease independently of other major risk factors. We evaluated the risk of CV events in a well-phenotyped cohort of patients with CP and its association with pancreatic exocrine insufficiency (PEI) among other CV risk factors. METHODS: This was a prospective, longitudinal cohort study of patients with CP, followed up at the Pancreas Unit of the University Hospital of Santiago de Compostela, Spain. RESULTS: Four hundred thirty patients were included (mean 47.8 ± 14.4 years of age, 79.1% male). Mean follow-up was 8.6 ± 4.6 years. CP etiology was toxic (alcohol and/or smoking) in 290 patients (67.4%). PEI and pancreatogenic diabetes mellitus (DM) were present in 29.3% and 29.5% of the patients, respectively. A total of 45 CV events was recorded (10.5%); 21 patients had a major CV event (stroke or myocardial infarction) and 27 developed clinically relevant peripheral arterial disease. A higher incidence of CV events was recorded in patients with PEI than in those without (incidence rate ratio 3.67, 95% confidence interval [CI] 1.92-7.24; P < 0.001). In the multivariate analysis, PEI without DM (OR 4.96; 95% CI 1.68 to 14.65), coexistence of PEI and DM (OR 6.54; 95% CI 2.71 to 15.77), arterial hypertension (OR 3.40; 95% CI 1.50 to 7.72), and smoking (OR 2.91, 95% CI 1.07 to 7.97) were independently associated with increased CV risk. CONCLUSIONS: Together with known major CV risk factors like smoking and hypertension, PEI is significantly associated with the risk of CV events in patients with CP.

Endoscopic ultrasound (EUS) guided fine needle biopsy (FNB) with the Procore™ needle provides inadequate material for the histological diagnosis of early chronic pancreatitis.

BACKGROUND: diagnosis of early chronic pancreatitis (CP) is hampered due to the low accuracy of current imaging techniques and the absence of methods for histological confirmation. We aimed to evaluate the efficacy of endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) for the histological diagnosis of early CP. METHODS: a prospective, cross-sectional, single-center study was designed. Consecutive patients referred for EUS with a clinical suspicion of CP were evaluated for inclusion into the study. Inclusion criteria were age > 18 years and indeterminate EUS findings for the diagnosis of CP according to the Rosemont classification. EUS-FNB of the body of the pancreas was performed with Procore™ needles. Tissue samples were immersed into a methanol-based buffered preservative solution for cytohistological evaluation. The quality of the samples obtained and the histological findings were evaluated. Procedure-related complications were recorded. RESULTS: the study was stopped after eleven patients were included due to safety concerns and poor diagnostic yield. The mean age of the patients was 50.3 years (range 33-70 years) and six were male. Samples were of poor quality in five cases, but were sufficient for cell-block evaluation. An inflammatory infiltration with mild fibrosis was identified in two cases and neither inflammatory infiltration nor fibrosis was identified in three cases. With regard to the other six cases, isolated inflammatory cells were observed in one case, although the cellularity was poor and unsuitable for cytological evaluation in five cases. There was one major complication (9.1%) of acute pancreatitis that required hospitalization for 48 hours. CONCLUSION: EUS-FNB is technically feasible in patients with EUS findings categorized as indeterminate for a CP diagnosis. However, the diagnostic yield is poor and there is a non-negligible risk of complications.

Impact of the treatment of pancreatic exocrine insufficiency on survival of patients with unresectable pancreatic cancer: a retrospective analysis.

BACKGROUND: Malnutrition and weight loss are commonly observed in patients with pancreatic cancer and contribute to poor survival. Pancreatic exocrine insufficiency (PEI), which can be caused by ductal obstruction by a tumor, causes maldigestion and malabsorption of nutrients, thus contributing to malnutrition in these patients. In this study, we evaluated the effects of pancreatic enzyme replacement therapy (PERT) on survival in patients with unresectable pancreatic cancer. METHODS: A retrospective analysis was conducted on a database of patients with unresectable, pathologically confirmed pancreatic cancer. All patients were evaluated for palliative chemotherapy and received the optimal palliative care. Patients were divided into two groups: Group 1 received standard therapy; Group 2 underwent additional evaluation of the pancreatic function and therapy with PERT, if needed. Survival (median and 95% confidence interval [CI]) was analyzed using Kaplan-Meier and Cox regression; groups were compared using the log-rank test. RESULTS: Overall, 160 patients with unresectable pancreatic cancer were included in the analysis (mean age: 70.5 years [range 28-100]; gender: 57.5% male; tumor stage: 78.7% Stage IV). Eighty-six patients (53.75%) were in Group 1 and 74 (46.25%) were in Group 2. Age, gender, tumor size, location and stage, weight loss, and serum CA 19-9 were similar between groups. Ninety-three (58.1%) patients received palliative chemotherapy; 46.5% in Group 1 and 71.6% in Group 2 (P < 0.001). Forty-nine (66.2%) patients in Group 2 and none in Group 1 received PERT. Survival in Group 2 (189 days, 95% CI 167.0-211.0 days) was significantly longer than in Group 1 (95.0 days, 95% CI 75.4-114.6 days) (HR 2.117, 95% CI 1.493-3.002; P < 0.001). Chemotherapy and PERT were significantly and independently associated with longer survival in a model controlled by age and tumor stage. In patients with significant weight loss at diagnosis (> 10% bodyweight within 6 months), PERT was associated with longer survival (HR 2.52, 95% CI 1.55-4.11; P < 0.001). CONCLUSIONS: In patients with unresectable pancreatic cancer, PERT in patients with PEI was associated with longer survival compared with those not receiving PERT, especially in those experiencing significant weight loss. This finding should guide future prospective clinical trials of similar interventions.

Endoscopic ultrasound cytologic brushing vs endoscopic ultrasound - fine needle aspiration for cytological diagnosis of cystic pancreatic lesions. A multicenter, randomized open-label trial.

INTRODUCTION: the incidence of cystic pancreatic lesions (CPL) in the asymptomatic population is increasing. Achieving a preoperative diagnosis of CPL still remains a challenge. OBJECTIVES: to evaluate the diagnostic accuracy of the cytological diagnosis of CPL from samples obtained by cytology brush versus standard endoscopic ultrasound fine needle aspiration (EUS-FNA). METHODS: a multicenter, randomized, open-label trial was performed of EUS-cytology brush (EUS-EB) versus EUS-FNA for the cytological diagnosis of CPL. Patients that underwent EUS-FNA with a CPL > 15 mm were included and randomized into two groups: group I, EUS-EB; group II, EUS-FNA. The final diagnosis was based on the histological evaluation of surgical specimens and clinical parameters, imaging and a five year follow-up in non-operated patients. The main outcome was the diagnostic accuracy of both methods. Secondary outcomes were the diagnostic adequacy of specimens and the rate of adverse events. Data were compared using the Chi-squared test. An intention to treat (ITT) and per-protocol (PP) analysis were performed. RESULTS: sixty-five patients were included in the study, 31 in group I and 34 in group II. Three patients initially randomized to group I were changed to group II as it was impossible to obtain a sample using the brush. The mean size of the CPL was 28.2 mm (range 16-60 mm). The diagnostic accuracy of EUS-EB was not superior to EUS-FNA, neither in the ITT nor the PP analysis (44.8% vs 41.1%, p = 0.77 and 38.4% vs 45.9%, p = 0.55). CONCLUSIONS: EUS-EB does not improve the diagnostic accuracy of CPL in comparison with EUS-FNA.