BackgroundThe current standard of care of screening and referring patients for treatment for symptoms, such as depression, pain, and fatigue, is not effective. This trial aimed to test the efficacy of an integrated screening and novel stepped collaborative care intervention versus standard of care for patients with cancer and at least one of the following symptoms: depression, pain, or fatigue.MethodsThis randomised, parallel, phase 3 trial was conducted in 29 oncology outpatient clinics associated with the UPMC Hillman Cancer Center in the USA. Patients (aged ≥21 years) with any cancer type and clinical levels of depression, pain, or fatigue (or all of these) were eligible. Eligible family caregivers were aged 21 years or older and providing care to a patient diagnosed with cancer who consented for this study. Patients were randomly assigned (1:1) to stepped collaborative care or standard of care using a central, permuted block design (sizes of 2, 4, and 6) stratified by sex and prognostic status. The biostatistician, oncologists, and outcome assessors were masked to treatment assignment. Stepped collaborative care was once-weekly cognitive behavioural therapy for 50–60 min from a care coordinator via telemedicine (eg, telephone or videoconferencing). Pharmacotherapy for symptoms might be initiated or changed if recommended by the treatment team or preferred by the patient. Standard of care was screening and referral to a health-care provider for treatment of symptoms. The primary outcome was health-related quality of life in patients at 6 months. Maintenance of the treatment benefits was assessed at 12 months. Participants included in the primary analysis were per intention to treat, which included patients missing one or both follow-up assessments. This trial was registered with ClinicalTrials.gov (NCT02939755).FindingsBetween Dec 5, 2016, and April 8, 2021, 459 patients and 190 family caregivers were enrolled. 222 patients were assigned to standard of care and 237 to stepped collaborative care. Of 459 patients, 201 (44%) were male and 258 (56%) were female. Patients in the stepped collaborative care group had a greater 0–6-month improvement in health-related quality of life than patients in the standard-of-care group (p=0·013, effect size 0·09). Health-related quality of life was maintained for the stepped collaborative care group (p=0·74, effect size 0·01). Patients in the stepped collaborative care group had greater 0–6-month improvements than the standard-of-care group in emotional (p=0·012), functional (p=0·042), and physical (p=0·033) wellbeing. No adverse events were reported by patients in either group and deaths were considered unrelated to the study.InterpretationAn integrated screening and novel stepped collaborative care intervention, compared with the current standard of care, is recommended to improve health-related quality of life. The findings of this study will advance the implementation of guideline concordant care (screening and treatment) and has the potential to shift the practice of screening and treatment paradigm nationwide, improving outcomes for patients diagnosed with cancer.FundingUS National Cancer Institute.
Background: The aim of this Phase III trial was to test the efficacy of an integrated screening and stepped collaborative care intervention (CARES) versus screening and standard of care (SC) for patients with comorbid cancer and depression, pain, and/or fatigue.Methods: The study was a parallel-group, single blind, randomized controlled trial. Outpatients with cancer and clinical levels of depression, pain, and/or fatigue were enrolled. Participants were randomly assigned in a 1:1 ratio with stratification by sex and prognostic status by cancer type. CARES is a manualized, novel stepped collaborative care intervention delivered by telemedicine. Outcomes were collected at 6- and 12-months with the primary outcome being health related quality of life (HRQoL). Secondary and tertiary outcomes included family caregiver risk of cardiovascular disease (CVD) and health care utilization and costs. Treatment allocation was masked for the biostatistician, oncologists, and outcome assessors. Findings: 459 participants and 190 family caregivers were enrolled between December 2016 to April 2021. Patients allocated to CARES had a greater 0-to-6 month improvement in HRQOL versus patients allocated to the SC arm [t(579)=2.23, p=.0259] and these gains were maintained from 6-to12-months [t(561)=-1.34, p>.10]. Patients allocated to CARES, when compared to SC, had greater 0-to-6 months improvements on the emotional [t(1,856)=2.27, p=0.012], functional [t(1, 891)=1.73, p=0.042]; and physical well-being [t(1,777)=1.84, p=0.033]. Family caregivers, of patients allocated to CARES, had lower lifetime CVD risk scores, when compared to family caregivers of patients allocated to SC [uMVχ2=9.00, p=0.027]. Cost savings of US$16,892 per patient allocated to CARES versus SC was observed. The drivers of the lower activity-based costs for CARES were shorter length of stay in the hospital, fewer emergency room visits, and trends toward fewer 90-day readmissions. Interpretation: Cancer centers may consider this integrated screening and treatment program to improve patient quality of life and save health care costs.Trial Registration: ClinicalTrials.gov NCT02939755.Funding: National Cancer Institute R01CA176809 with Administrative and Diversity Supplement; Clinical and Translation Sciences Institute UL1-TR-001857.Declaration of Interest: We declare not competing interests.Ethical Approval: Prior to the commencement of the study, the investigators received Institutional Review Board approval (PRO15030290). If the patient screened positive, they were explained the risks and benefits of the study and if provided written consent enrolled in the study.
BACKGROUND:The NIH consensus statement on cancer-related symptoms concluded the most common and debilitating were depression, pain and fatigue [1-6]. Although the comorbidity of these symptoms is well known and may have similar underlying biological mechanisms no intervention has been developed to reduce these symptoms concurrently. The novel web-based stepped collaborative care intervention delivered by telemedicine is the first to be tested in people diagnosed with cancer. METHODS:We plan to test a web-based stepped collaborative care intervention with 450 cancer patients and 200 caregivers in the context of a randomized controlled trial. The primary endpoint is quality of life with other primary outcomes including patient-reported depression, pain, fatigue. Secondary outcomes include patient serum levels of pro-inflammatory cytokines and disease progression. We also will assess informal caregiver stress, depression, and metabolic abnormalities to determine if improvements in patients' symptoms also relate to improvement in caregiver outcomes. RESULTS:The trial is ongoing and a total of 382 patients have been randomized. Preliminary analyses of the screening tools used for study entry suggest that Center for Epidemiological Studies-Depression (CESD) scale has good sensitivity and specificity (0.81 and 0.813) whereas the scale used to assess pain (0.47 and 0.91) and fatigue (0.11 and 0.91) had poor sensitivity but excellent specificity. Using the AUROC, the best cut point for the CES-D was 19, for pain was 4.5; and for fatigue was 2.5. Outcomes not originally proposed included health care utilization and healthcare charges. The first 100 patients who have been followed a year post-treatment, and who were less than 75 years and randomized to the web-based stepped collaborative care intervention, had lower rates of complications after surgery [χ2 = 5.45, p = 0.02]. For patients who survived 6 months or less and were randomized to the web-based stepped collaborative care intervention, had lower rates of 90-day readmissions when compared to patients randomized to the screening and referral arm [χ2 = 4.0, p = 0.046]. Patients randomized to the collaborative care intervention arm had lower overall health care activity-based costs of $16,758 per patient per year when compared to the screening and referral arm. DISCUSSION:This novel web-based stepped stepped collaborative care intervention, delivered via telemedicine, is expected to provide a new strategy to improve the quality of life in those diagnosed with cancer and their caregivers. TRIAL REGISTRATION:ClinicalTrials.govNCT02939755.
BACKGROUND & AIMS: Imaging patterns from endoscopic ultrasound (EUS)-guided needle-based confocal laser endomicroscopy (nCLE) have been associated with specific pancreatic cystic lesions (PCLs). We compared the accuracy of EUS with nCLE in differentiating mucinous from nonmucinous PCLs with that of measurement of carcinoembryonic antigen (CEA) and cytology analysis. METHODS: We performed a prospective study of 144 consecutive patients with a suspected PCL (>= 20 mm) who underwent EUS with fine-needle aspiration of pancreatic cysts from June 2015 through December 2018 at a single center; 65 patients underwent surgical resection. Surgical samples were analyzed by histology (reference standard). During EUS, the needle with the miniprobe was placed in the cyst, which was analyzed by nCLE. Fluid was aspirated and analyzed for level of CEA and by cytology. We compared the accuracy of nCLE in differentiating mucinous from nonmucinous lesions with that of measurement of CEA and cytology analysis. RESULTS: The mean size of dominant cysts was 36.4 +/- 15.7 mm and the mean duration of nCLE imaging was 7.3 +/- 2.8 min. Among the 65 subjects with surgically resected cysts analyzed histologically, 86.1% had at least 1 worrisome feature based on the 2012 Fukuoka criteria. Measurement of CEA and cytology analysis identified mucinous PCLs with 74% sensitivity, 61% specificity, and 71% accuracy. EUS with nCLE identified mucinous PCLs with 98% sensitivity, 94% specificity, and 97% accuracy. nCLE was more accurate in classifying mucinous vs nonmucinous cysts than the standard method (P < .001). The overall incidence of postprocedure acute pancreatitis was 3.5% (5 of 144); all episodes were mild, based on the revised Atlanta criteria. CONCLUSIONS: In a prospective study, we found that analysis of cysts by nCLE identified mucinous cysts with greater accuracy than measurement of CEA and cytology analysis. EUS with nCLE can be used to differentiate mucinous from nonmucinous PCLs.
BACKGROUND AND AIMS:Previous studies have validated EUS-guided needle-based confocal laser endomicroscopy (nCLE) diagnosis of intraductal papillary mucinous neoplasms (IPMNs). We sought to derive EUS-guided nCLE criteria for differentiating IPMNs with high-grade dysplasia/adenocarcinoma (HGD-Ca) from those with low/intermediate-grade dysplasia (LGD). METHODS:We performed a post hoc analysis of consecutive IPMNs with a definitive diagnosis from a prospective study evaluating EUS-guided nCLE in the diagnosis of pancreatic cysts. Three internal endosonographers reviewed all nCLE videos for the patients and identified potential discriminatory EUS-guided nCLE variables to differentiate HGD-Ca from LGD IPMNs (phase 1). Next, an interobserver agreement (IOA) analysis of variables from phase 1 was performed among 6 blinded external nCLE experts (phase 2). Last, 7 blinded nCLE-naïve observers underwent training and quantified variables with the highest IOA from phase 2 using dedicated software (phase 3). RESULTS:Among 26 IPMNs (HGD-Ca in 16), the reference standard was surgical histopathology in 24 and cytology confirmation of metastatic liver lesions in 2 patients. EUS-guided nCLE characteristics of increased papillary epithelial "width" and "darkness" were the most sensitive variables (90%; 95% confidence interval [CI], 84%-94% and 91%; 95% CI, 85%-95%, respectively) and accurate (85%; 95% CI, 78%-90% and 84%; 95% CI, 77%-89%, respectively) with substantial (κ = 0.61; 95% CI, 0.51-0.71) and moderate (κ = 0.55; 95% CI, 0.45-0.65) IOAs for detecting HGD-Ca, respectively (phase 2). Logistic regression models were fit for the outcome of HGD-Ca as predictor variables (phase 3). For papillary width (cut-off ≥50 μm), the sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) for detection of HGD-Ca were 87.5% (95% CI, 62%-99%), 100% (95% CI, 69%-100%), and 0.95, respectively. For papillary darkness (cut-off ≤90 pixel intensity), the sensitivity, specificity, and AUC for detection of HGD-Ca were 87.5% (95% CI, 62%-99%), 100% (95% CI, 69%-100%), and 0.90, respectively. CONCLUSIONS:In this derivation study, quantification of papillary epithelial width and darkness identified HGD-Ca in IPMNs with high accuracy. These quantifiable variables can be used in multicenter studies for risk stratification of IPMNs. (Clinical trial registration number: NCT02516488.).
INTRODUCTION: Barrett's esophagus (BE) affects up to 15% of patients with gastroesophageal reflux disease and poses high risk of progression to esophageal adenocarcinoma (EAC). While radiofrequency ablation (RFA) and endoscopic mucosal resection (EMR) are effective treatments for dysplastic BE, risk of recurrence remains even after complete eradication of intestinal metaplasia (CEIM). Currently, endoscopic surveillance intervals after RFA ± EMR are informed only by expert opinion and weak evidence. It is unclear if current guidelines are cost-effective or suitable for all patients. The purpose of this study is to assess for variation in surveillance intervals and rates of recurrence in BE patients with high grade dysplasia (HGD). METHODS: A retrospective review of medical records was performed for 70 BE patients who underwent RFA ± EMR for biopsy-proven HGD between January 1, 2010 until November 30, 2018 and received at least 1 surveillance endoscopy with biopsies at 1 year after completion of treatment. These patients were analyzed for adherence to the ACG guidelines of an endoscopy every 3 months for the first year after treatment and for recurrence of dysplasia or development of EAC. RESULTS: At 1 year post treatment completion, CEIM was achieved in 48.6% of patients and non-dysplastic BE was achieved in 32.9% of patients. The average time between the first 4 surveillance intervals was 5.5 months. 14 of 70 patients were adherent to ACG guidelines, and 56 received endoscopies less frequently than recommended. Of the 14 patients who were adherent, 6 developed recurrent dysplasia (1 low grade dysplasia (LGD), 4 HGD) and 1 developed T1b carcinoma at one year. Of the 56 patients who received surveillance endoscopies less frequently than recommended, 7 developed recurrent dysplasia (4 LGD, 3 HGD) at one year. CONCLUSION:: Adhering to ACG surveillance guidelines following RFA±EMR treatment for HGD is difficult and requires close attention to the scheduling of these BE patients. Although our sample size is small, our study showed that the recurrence of dysplasia was not significantly reduced in individuals that were adherent to the ACG guidelines when compared to those that received surveillance less frequently than recommended. Further studies are needed to inform the development of evidence-based guidelines that identify recurrence or progression of dysplastic BE early, while minimizing the costs of over-surveillance.
Borderline resectable pancreatic cancer (BRPC) represents only about 10% of all patients with pancreatic cancer.1 Upfront surgery for BRPC leads to high rates of R1 or R2 resection, local recurrence, and distant metastasis.2 Therefore neoadjuvant chemotherapy with chemoradiation (CRT) is becoming the preferred treatment approach for BRPC. Modern multiagent chemotherapy in this setting often includes FOLFIRINOX (fluorouracil, irinotecan, oxaliplatin, and folinic acid) or gemcitabine and nab-paclitaxel, whereas single-agent gemcitabine, fluorouracil, or capecitabine are commonly used as radiosensitizers during chemoradiation.
Objective The aim of this study is to determine the diagnostic accuracy of preoperative evaluation to detect main pancreatic duct involvement in pancreatic cystic lesions thus differentiating mixed intraductal papillary mucinous neoplasm (IPMN) from branch duct (BD)–IPMN. Methods The pathology database of pancreatic resections from 2000 to 2014 was reviewed. Main pancreatic duct-IPMNs and IPMNs with intracystic mass/nodules were excluded. The preoperative test characteristics were analyzed using surgical histopathology as the “gold standard.” Results Sixty BD-IPMNs and 23 mixed-IPMNs were identified. Mixed-IPMNs were larger (mean [standard deviation], 4.14 [2.9] vs 2.74 [1.9] mm; P = 0.03) and demonstrated frequent high-grade dysplasia/adenocarcinoma (43% vs 12%, P = 0.004) than BD-IPMNs. Endoscopic ultrasound (EUS) (sensitivity, 80%; specificity, 78%; accuracy, 79%) had the best diagnostic accuracy, whereas magnetic resonance imaging (MRI) (sensitivity, 83%; specificity, 63%; accuracy, 68%) had the highest sensitivity for the diagnosis of mixed-IPMN. A combination of EUS and MRI reached maximum sensitivity but with decreased accuracy (sensitivity, 100%; specificity, 64%; accuracy, 67%). The area under the curve for receiver operation curve was 0.71 whereas the optimal cyst size to detect main duct involvement was 3 cm. Conclusions For preoperative evaluation of pancreatic cystic lesions without evidence of intracystic nodules, a combination of MRI and EUS should be considered for improved detection of main duct involvement.
Introduction: Prior studies have validated EUS-guided needle-based confocal laser endomicroscopy (nCLE) diagnosis of IPMNs by detection of characteristic “papillae”. We sought to further assess the performance and interobserver agreement (IOA) of EUS-nCLE for differentiating IPMNs with high grade dysplasia (HGD) or adenocarcinoma (HGD-Ca) from those with low or intermediate-grade dysplasia (LGD). Methods: In a prospective single center study evaluating EUS-nCLE for the evaluation of pancreatic cysts, 26 patients with a definitive diagnosis of IPMNs (surgery=24; confirmatory cytology/metastatic adenocarcinoma=2) were identified. EUS-nCLE imaging variables predictive (Table 1) of advanced neoplasia were internally derived amongst 3 EUS-MDs with experience in nCLE (Fig. 1). Six external endosonographers (nCLE experience>30 cases) blinded to all clinical data, reviewed all nCLE videos (Fig. 2).5_A Figure 1. EUS-guided needle based confocal endomicroscopy imaging features in differentiating degree of dysplasia in IPMNs5_B Figure 2. EUS-guided needle based confocal endomicroscopy imaging variables predictive of advanced neoplasia: diagnostic parameters and interobserver agreement. CI: Confidence Interval.After 2 weeks, the assessors reviewed the same images in a different sequence. A self-study tutorial of nCLE variables predictive of HGD-Ca was provided before each review. Prior to the second review, an interactive web-based discussion was also conducted. The IOAs (κ statistic) of diagnostic nCLE image patterns to detect HGD-Ca were calculated.5_C Figure 3. Study designResults: Among the subjects with IPMNs (16 mixed, 10 branch-duct; mean size 3.4±1.7 cm), there were 9 with LGD and 17 with advanced neoplasia (12 HGD, 2 non-invasive and 3 invasive adenocarcinoma). The six observers identified papillary structures diagnostic of IPMN in all videos. The overall sensitivity, specificity, accuracy, and IOA of EUS-nCLE to diagnose HGD-Ca was 90%, 73%, 84%, and κ=0.54 (moderate), respectively (Table 1). Correlating with histopathological progression of dysplasia in IPMNs, nCLE imaging characteristics of papillary “thickness” (indicative of cellular and nuclear stratification) and “darkness” (increased nuclear/cytoplasmic ratio) were the most sensitive (90% and 91%) and accurate (86% and 84%) with substantial (κ=0.61) and moderate (κ=0.55) IOAs for detecting HGD-Ca, respectively (Table 1). Conclusion: In this derivation study, blinded expert endosonographers identified several EUS-nCLE imaging features of IPMNs that are associated with advanced neoplasia. Further studies are needed to refine and validate these features for applying EUS-nCLE to identify advanced dysplasia.
The management of pancreatic cystic lesions (PCLs) is complex, with evolving guidelines over time. We sought to compare appropriateness of surgeries based on operative pathology before and after implementation of International Consensus Guidelines (ICG; 2012), dedicated multidisciplinary pancreas team, and novel diagnostic modalities. Consecutive subjects who underwent EUS-fine needle aspiration prior to resection of PCL were enrolled in the study. The study time periods included the "current time period" (July 2014 to November 2017, 40 months) and "prior time period" (January 2009 to April 2013, 40 months). Diagnoses based on surgical histopathology. Subjects were excluded if there was evidence of metastatic disease on imaging study, main duct intraductal papillary mucinous neoplasm (MD-IPMN), surgery performed for chronic or acute pancreatitis, solid pancreatic lesions, and cyst size <1.5 cm. We collected demographic and clinical features, PCL morphology on imaging and EUS, cyst fluid analysis, details of surgical histopathology, high and worrisome risk features (ICG 2012), and indication for resection. A total of 107 subjects met the inclusion criteria for study. 55 subjects (mean age 59.2±13.2; 62% female) underwent pancreatic resections in the prior time-period and 52 subjects (mean age 62.0 ± 13.0; 50% female) in the current time-period. PCLs with a larger cyst size were resected in the current time-period compared to the prior era (4.1 ± 2.1 cm vs. 3.2 ± 2.0 cm; p = 0.03). Previously, a higher proportion of subjects with high CEA and suspicious cytology in the absence of worrisome/high risk ICG features (25 vs. 0) were resected (Table 1), while in the current-time period the majority of the PCLs had at least one worrisome criteria present (65.4% vs. 23.6%, p <0.01). In the prior time-period, a higher proportion of resected IMPNs had low-grade dysplasia (31% vs. 17.4%, p = 0.05), while in the current time-period the majority of the cysts resected had high-grade dysplasia (65.4% vs. 15.0%, p = 0.03). A dedicated multidisciplinary team guided by ICG guidelines and novel diagnostic modalities improves the proportion of patients undergoing appropriate resection for PCLs at a single tertiary care center.Tabled 1Table 1. Demographics, clinical features, and histopathology of patients who underwent resection of pancreatic cystic lesionsVariablePrior-time period%Current-time period%p-valueN: 55N: 52Clinical featuresCyst size (cm), mean (SD)3.2 ± (2.03)4.1 ± (2.01)0.03Age (years), mean (SD)59.2 ± (13.2)61.0 ± (13.0)0.05Female34622650<0.01CEA ≥ 192*2054.12252.41.0Reason for surgeryHigh risk ICG 2012712.714270.09Worrisome ICG 20121323.63465.4<0.01High CEA in absence of high risk/worrisome criteria712.7--Patient decision/symptomatic814.647.60.36Abnormal or suspicious cytology in absence of high risk/worrisome criteria1832.7--DiagnosisOther benign cyst**23.659.60.26Pseudocyst35.535.81.0Cystic NET814.559.60.56IPMN-BD/Mix2545.52446.21.0MCN1120815.40.62Serous Cystadenoma59.123.80.44Other Cancer11.859.60.11Dysplasia Degree, IPMNLow-grade Dysplasia1731917.40.05High-grade Dysplasia/Adenocarcinoma8153465.40.03Total IMPN254524461.0 Open table in a new tab
Background and Aims: EUS-guided needle-based confocal laser endomicroscopy (nCLE) characteristics of common types of pancreatic cystic lesions (PCLs) have been identified; however, surgical histopathology was available in a minority of cases. We sought to assess the performance characteristics of EUS nCLE for differentiating mucinous from non-mucinous PCLs in a larger series of patients with a definitive diagnosis.Methods: Six endosonographers (nCLE experience >30 cases each) blinded to all clinical data, reviewed nCLE images of PCLs from 29 patients with surgical (n=23) or clinical (n=6) correlation. After 2 weeks, the assessors reviewed the same images in a different sequence. A tutorial on available and novel nCLE image patterns was provided before each review. The performance characteristics of nCLE and the kappa statistic for interobserver agreement (IOA, 95% confidence interval [CI]), and intraobserver reliability (IOR, mean +/- standard deviation [SD]) for identification of nCLE image patterns were calculated. Landis and Koch interpretation of kappa values was used.Results: A total of 29 (16 mucinous PCLs, 13 non-mucinous PCLs) nCLE patient videos were reviewed. The overall sensitivity, specificity, and accuracy for the diagnosis of mucinous PCLs were 95%, 94%, and 95%, respectively. The IOA and IOR (mean +/- SD) were kappa =0.81 (almost perfect); 95% CI, 0.71-0.90; and kappa =0.86 +/- 0.11 (almost perfect), respectively. The overall specificity, sensitivity, and accuracy for the diagnosis of serous cystadenomas (SCAs) were 99%, 98%, and 98%, respectively. The IOA and IOR (mean +/- SD) for recognizing the characteristic image pattern of SCA were kappa = 0.83 (almost perfect); 95% CI, 0.73-0.92; and kappa = 0.85 +/- 0.11 (almost perfect), respectively.Conclusions: EUS-guided nCLE can provide virtual histology of PCLs with a high degree of accuracy and inter- and intraobserver agreement in differentiating mucinous versus non-mucinous PCLs. These preliminary results support larger multicenter studies to evaluate EUS nCLE.
Endoscopic ultrasonography (EUS)-guided needle based confocal laser endomicroscopy (nCLE) is a novel diagnostic tool for diagnosis of pancreatic cystic lesions (PCLs). We have recently evaluated and externally validated specific EUS-nCLE patterns of PCLs. The aim of this study was to develop a decision tree analysis for diagnostic PCLs utilizing EUS-nCLE image patterns.
Background and Objectives: Endoscopic ultrasonography (EUS)-guided needle-based confocal laser endomicroscopy (nCLE) patterns for diagnosing mucinous pancreatic cystic lesions (PCLs) have been recently validated. The aim of this study was to compare the accuracy of EUS-nCLE to the standard of care for differentiating mucinous from nonmucinous PCLs. Methods: In a prospective study evaluating EUS-nCLE, fluid from 59 PCLs was analyzed by carcinoembryonic antigen (CEA), cytology, and next generation sequencing (NGS). The final diagnosis of PCLs was based on surgical histopathology (n = 36 [61%]) or clinical diagnosis based on imaging features, specific NGS results, follow-up >1 year, and/or resolution of PCL (n = 23 [39%]). Diagnostic indices and area under receiver operator curve (ROC) of different modalities were computed for all subjects. Results: Among the 59 subjects (31 females; mean age 59.4 years), 36 cysts were mucinous and 23 nonmucinous. The ROC analyses associated with the detection of patterns of “epithelial bands/papillae” for mucinous PCLs demonstrated the greatest area under the curve (96%). The sensitivity, specificity, and accuracy of nCLE were significantly greater than the accuracy of CEA, cytology, and combination of CEA/cytology (P < 0.001). When the study population was restricted to those with surgical histopathology (n = 36; mucinous 26 [72%]), diagnostic accuracy of nCLE for mucinous PCLs continued to be higher than the combination of CEA/cytology (94% vs. 67%, P = 0.006). Conclusions: Among the current diagnostic modalities, EUS-nCLE detection of “epithelial bands or papillae” is more accurate than the current “standard of care” for the differentiation of mucinous from nonmucinous PCLs. These preliminary results warrant further validation in larger, multicenter studies.
Due to suboptimal diagnostic accuracy of the current standard of care (cyst fluid CEA and cytology) in differentiating mucinous versus non-mucinous pancreatic cystic lesions (PCLs), the 2015 American Gastroenterological Association (AGA) guidelines for asymptomatic pancreatic cystic lesions (PCLs) recommend endoscopic ultrasound (EUS) when two high-risk features including size ≥ 3 cm, dilated main pancreatic duct, or presence of an associated solid component are identified. EUS-guided needle based confocal laser endomicroscopy (nCLE) is a novel technology with specific patterns for mucinous PCLs having been described and validated among independent external observers. The aim of this study was to assess the impact of EUS-nCLE on AGA guidelines in the management of PCLs.
dose aspirin (81mg) decreased the likelihood of being prescribed a PPI.These results create an opportunity to improve primary prevention of GIB through targeted education and quality improvement interventions.