EUS vs. ERCP-guided primary drainage of inoperable distal malignant biliary obstruction: systematic review and meta-analysis of randomized controlled trials.

BACKGROUND AND AIMS: Several randomized controlled trials (RCTs) compared endoscopic ultrasound-guided biliary drainage (EUS-BD) to endoscopic retrograde cholangiopancreatography (ERCP) as first-line interventions in distal malignant biliary obstruction (DMBO). We assessed the efficacy and safety of these two approaches. METHODS: A PubMed/Medline, Embase and Cochrane databases bibliographic search until 01/12/2023 was performed to identify RCTs comparing EUS-BD to ERCP for primary biliary drainage in inoperable patients with DMBO. Primary outcome was technical success. Secondary outcomes were clinical success, adverse events (AEs), mean procedure time, 1-year stent patency, and overall survival. Relative risk (RR) with 95% confidence interval (CI) were calculated using random-effect model. RESULTS: Five studies (519 patients) were included. The RR for pooled technical success in EUS-BD was 1.06 ([0.96-1.17]; P=0.27) and 1.02 [0.97-1.08]; P=0.45) for clinical success. 1-year stent patency was similar among the two groups (RR 1.15; [0.94-1.42], P=0.17), with lower reintervention in the EUS-BD group (RR 0.58; [0.37-0.9]; P=0.01). The RR of AEs rate was 0.85 [0.49-1.46]; P=0.55) and severe AEs of 0.97 [0.10-0.17]; P=0.98). On subgroup analysis, EUS-lumen apposing metal stents (LAMS) outperformed ERCP in term of technical success (RR 1.17; [1.01-1.35]; P=0.03). Procedure time was lower in EUS-BD (standardized mean difference -2.36 minutes; [-2.68 to -2.05]; P<0.001). CONCLUSIONS: EUS-BD showed a statistically significant lower re-intervention rate compared to ERCP, but with similar technical success rate, stent patency, clinical success rate and safety profile, while in the subgroup of EUS-LAMS, the technical success was better than ERCP Keywords: distal; biliary obstruction; efficacy; safety.

Curriculum for diagnostic endoscopic ultrasound training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

The European Society of Gastrointestinal Endoscopy (ESGE) has recognized the need to formalize and enhance training in diagnostic endoscopic ultrasound (EUS). This manuscript represents the outcome of a formal Delphi process resulting in an official Position Statement of the ESGE and provides a framework to develop and maintain skills in diagnostic EUS. This curriculum is set out in terms of the prerequisites prior to training; the recommended steps of training to a defined syllabus; the quality of training; and how competence should be defined and evidenced before independent practice. 1: Trainees should have achieved competence in upper gastrointestinal endoscopy before training in diagnostic EUS. 2: The development of diagnostic EUS skills by methods that do not involve patients is advisable, but not mandatory, prior to commencing formal training in diagnostic EUS. 3: A trainee's principal trainer should be performing adequate volumes of diagnostic EUSs to demonstrate maintenance of their own competence. 4: Training centers for diagnostic EUS should offer expertise, as well as a high volume of procedures per year, to ensure an optimal level of quality for training. Under these conditions, training centers should be able to provide trainees with a sufficient wealth of experience in diagnostic EUS for at least 12 months. 5: Trainees should engage in formal training and supplement this with a range of learning resources for diagnostic EUS, including EUS-guided fine-needle aspiration and biopsy (FNA/FNB). 6: EUS training should follow a structured syllabus to guide the learning program. 7: A minimum procedure volume should be offered to trainees during diagnostic EUS training to ensure that they have the opportunity to achieve competence in the technique. To evaluate competence in diagnostic EUS, trainees should have completed a minimum of 250 supervised EUS procedures: 80 for luminal tumors, 20 for subepithelial lesions, and 150 for pancreaticobiliary lesions. At least 75 EUS-FNA/FNBs should be performed, including mostly pancreaticobiliary lesions. 8: Competence assessment in diagnostic EUS should take into consideration not only technical skills, but also cognitive and integrative skills. A reliable valid assessment tool should be used regularly during diagnostic EUS training to track the acquisition of competence and to support trainee feedback. 9: A period of supervised practice should follow the start of independent activity. Supervision can be delivered either on site if other colleagues are already practicing EUS or by maintaining contacts with the training center and/or other EUS experts. 10: Key performance measures including the annual number of procedures, frequency of obtaining a diagnostic sample during EUS-FNA/FNB, and adverse events should be recorded within an electronic documentation system and evaluated.

Endoscopic management of subepithelial lesions including neuroendocrine neoplasms: European Society of Gastrointestinal Endoscopy (ESGE) Guideline.

1: ESGE recommends endoscopic ultrasonography (EUS) as the best tool to characterize subepithelial lesion (SEL) features (size, location, originating layer, echogenicity, shape), but EUS alone is not able to distinguish among all types of SEL.Strong recommendation, moderate quality evidence. 2: ESGE suggests providing tissue diagnosis for all SELs with features suggestive of gastrointestinal stromal tumor (GIST) if they are of size > 20 mm, or have high risk stigmata, or require surgical resection or oncological treatment.Weak recommendation, very low quality evidence. 3: ESGE recommends EUS-guided fine-needle biopsy (EUS-FNB) or mucosal incision-assisted biopsy (MIAB) equally for tissue diagnosis of SELs ≥ 20 mm in size.Strong recommendation, moderate quality evidence. 4: ESGE recommends against surveillance of asymptomatic gastrointestinal (GI) tract leiomyomas, lipomas, heterotopic pancreas, granular cell tumors, schwannomas, and glomus tumors, if the diagnosis is clear.Strong recommendation, moderate quality evidence. 5: ESGE suggests surveillance of asymptomatic esophageal and gastric SELs without definite diagnosis, with esophagogastroduodenoscopy (EGD) at 3-6 months, and then at 2-3-year intervals for lesions < 10 mm in size, and at 1-2-year intervals for lesions 10-20 mm in size. For asymptomatic SELs > 20 mm in size that are not resected, ESGE suggests surveillance with EGD plus EUS at 6 months and then at 6-12-month intervals.Weak recommendation, very low quality evidence. 6: ESGE recommends endoscopic resection for type 1 gastric neuroendocrine neoplasms (g-NENs) if they grow larger than 10 mm. The choice of resection technique should depend on size, depth of invasion, and location in the stomach.Strong recommendation, low quality evidence. 7: ESGE suggests considering removal of histologically proven gastric GISTs smaller than 20 mm as an alternative to surveillance. The decision to resect should be discussed in a multidisciplinary meeting. The choice of technique should depend on size, location, and local expertise.Weak recommendation, very low quality evidence. 8: ESGE suggests that, to avoid unnecessary follow-up, endoscopic resection is an option for gastric SELs smaller than 20 mm and of unknown histology after failure of attempts to obtain diagnosis.Weak recommendation, very low quality evidence. 9: ESGE recommends basing the surveillance strategy on the type and completeness of resection. After curative resection of benign SELs no follow-up is advised, except for type 1 gastric NEN for which surveillance at 1-2 years is advised.Strong recommendation, low quality evidence. 10: For lower or upper GI NEN with a positive or indeterminate margin at resection, ESGE recommends repeating endoscopy at 3-6 months and another attempt at endoscopic resection in the case of residual disease.Strong recommendation, low quality evidence.

Antibioprophylaxis in endoscopic ultrasound guided fine needle aspiration in pancreatic cysts: A systematic review and meta-analysis.

Antibioprohylaxis (ABP) for pancreatic cystic lesion is still a debated clinical indication. Although professional societies guidelines still recommend ABP in endoscopic ultrasound-fine needle aspiration (EUS-FNA) for pancreatic cystic lesions (PCL), this standard of care recommendation was based on old and weakly planned studies with a small number of patients. Herein, in this work, we provide a critical review with pooled data analysis of the available literature. Overall, the studies reported are weak and limited with small number of patients, the absence of exact definition of infection and the heterogenicity of the type and the duration of the ABP used. Pooled data analysis showed that the effect of ABP on the rate of cyst infection was not significant (OR 0.56, 95% CI 0.17-1.2), with no significant heterogenicity between the results of the studies reviewed and reported (as assessed by Breslow Day test for homogeneity of OR's [P = 0.15]). The pooled infection rate without ABP was 0.89% and 0.36% in the ABP group. Moreover, according to the pooled data infection rate, sample size calculation demonstrated that 6954 patients are needed to show superiority of ABP, with a number needed to treat of 179 patients to prevent single infection. However, through the literature only six studies (1660 patients) reported the cyst infection rate among ABP versus control, making these results scarce and biased by a small number of patients. Therefore, we suggest the need to revise the guidelines, until performing well organized large international study to solve this controversy.

Oral anticoagulants but not antiplatelet agents increase the risk of delayed bleeding after endoscopic papillectomy: a large study in a tertiary referral center.

BACKGROUND: Endoscopic papillectomy (EP) is an effective curative treatment in patients with ampullary adenomas. However, EP is burdened by a not-negligible risk of bleeding. The aim of this study was to determine risk factors for delayed bleeding after EP. METHODS: A retrospective analysis of a prospectively-collected database was performed, retrieving all EP performed over a 20-year period. Anti-thrombotic treatments were managed according to guidelines. Delayed bleeding was defined as overt gastrointestinal bleeding or drop in haemoglobin level. Multivariate logistic regression was used to identify variables related to delayed bleeding. RESULTS: Three-hundred-seven patients (48.5% male, median age 68-year-old) entered the study; of them, 51 (16.6%) received anti-thrombotic treatments. Delayed bleeding occurred in 44 (14.3%) patients. No difference was observed in patients receiving antiplatelet agents. Multivariate analysis identified oral anticoagulant agents (odd Ratio 4.37 [2.86-5.95]) and procedural bleeding (OR 2.22 [1.10-4.40]) as independently related to delayed bleeding; in patients with no procedural bleeding, oral anticoagulant agents (OR 5.63 [2.25-9.83]) and ampullary tumor size (OR 1.07 [1.01-1.13]) were independently related to delayed bleeding. Patients on anticoagulant agents presented significantly higher need for blood transfusion (16.7 vs. 1.5%); no difference in intensive care unit admission, surgery or mortality was observed. CONCLUSIONS: This study demonstrates that patients on oral antiplatelet agents do not present increased risk for post-EP delayed bleeding. EP represents a valid alternative to surgery even in patients on anticoagulant agents, despite significantly increased risk of delayed bleeding. A tailored approach to those cases should be planned.

Contrast-enhanced EUS for the characterization of mural nodules within pancreatic cystic neoplasms: systematic review and meta-analysis.

BACKGROUND AND AIMS: Pancreatic cystic neoplasms (PCNs) carry a considerable malignancy risk. Along with main duct dilation, the presence of enhanced mural nodules represents a significant risk factor for malignancy. Several articles assessed the role of contrast-enhanced EUS (CE-EUS) for the identification of malignant features in mural nodules. We evaluate the pooled diagnostic performance of CE-EUS for the identification of high-grade dysplasia or invasive carcinoma among mural nodules in PCNs. METHODS: A systematic review (Medline, PubMed, EMBASE) and meta-analysis were conducted. Subgroup analysis was used to assess the usefulness of a dedicated contrast-harmonic (CH-EUS). The primary outcome was pooled sensitivity for identification of high-grade dysplasia or invasive carcinoma. RESULTS: Ten studies (532 patients) were included. Pooled sensitivity of CE-EUS was 88.2% (95% confidence interval [CI], 82.7%-92.5%), specificity 79.1% (95% CI, 74.5%-83.3%), and diagnostic accuracy 89.6% (95% CI, 83.4%-95.8%). Eight studies (320 patients) were conducted using CH-EUS: pooled sensitivity increased to 97.0% (95% CI, 92.5%-99.2%), specificity to 90.4% (95% CI, 85.2%-94.2%), and diagnostic accuracy to 95.6% (95% CI, 92.6%-98.7%). At 42% disease prevalence (pretest probability), a positive CH-EUS increased the disease probability to 88%, whereas a negative test decreased the disease probability to 2%. The number needed to diagnose was 1.5 (95% CI, 1.7-1.3) for CE-EUS and just 1.2 (95% CI, 1.3-1.1) for CH-EUS. CONCLUSIONS: This study provided robust evidence on CE-EUS value for the characterization of mural nodules within PCNs. A dedicated contrast-harmonic mode, namely CH-EUS, provided an increased diagnostic yield in the identification and characterization of malignant mural nodules.

Impact of the COVID-19 pandemic on gastrointestinal endoscopy activity in France.

BACKGROUND: The SARS-CoV-2 pandemic has majorly affected medical activity around the world. We sought to measure the impact of the COVID-19 pandemic on gastrointestinal (GI) endoscopy activity in France. METHODS: We performed a web-based survey, including 35 questions on the responders and their endoscopic practice, from 23 March to 27 March 2020, sent to the 3300 French gastroenterologists practicing endoscopy. RESULTS: 694 GI endoscopists (21 %) provided analyzable data; of these, 29.4 % (204/694) were involved in the management of COVID-19 patients outside the endoscopy department. During the study period, 98.7 % (685/694) of endoscopists had had to cancel procedures. There were 89 gastroenterologists (12.8 %) who reported symptoms compatible with COVID-19 infection, and a positive PCR test was recorded in 12/197 (6.1 %) vs. 3/497 (0.6 %) endoscopists in the high vs. low prevalence areas, respectively (P < 0.001). CONCLUSIONS: The COVID-19 pandemic led to a major reduction in the volume of GI endoscopies performed in France in March 2020. The prolonged limited access to GI endoscopy could lead to a delay in the management of patients with GI cancers.

Impact of needle-based confocal laser endomicroscopy on the therapeutic management of single pancreatic cystic lesions.

BACKGROUND AND AIM: The diagnosis and therapeutic management of large single pancreatic cystic lesions (PCLs) represent major issues for clinicians and essentially rely on endoscopic ultrasound fine-needle aspiration (EUS-FNA) findings. Needle-based confocal laser endomicroscopy (nCLE) has high diagnostic performance for PCLs. This study aimed to evaluate the impact of nCLE on the therapeutic management of patients with single PCLs. METHODS: Retrospective and comparative study. Five independent pancreatic disease experts from tertiary hospitals independently reviewed data from a prospective database of 206 patients with single PCL, larger than 2 cm and who underwent EUS-FNA and nCLE. Two evaluations were performed. The first one included the sequential review of clinical information, EUS report and FNA results. The second one included the same data + nCLE report. Participants had to propose a therapeutic management for each case. RESULTS: The addition of nCLE to EUS-FNA led to significant changes in therapeutic management for 28% of the patients (p < 0.001). nCLE significantly increased the interobserver agreement of 0.28 (p < 0.0001), from 0.36 (CI 95% 0.33-0.49) to 0.64 (CI 95% 0.61-0.67). nCLE improved the rates of full agreement among the five experts of 24% (p < 0.0001), from 30 to 54%. With nCLE, the surveillance rate of benign SCAs fell by 35%, from 40 (28/70) to 5% (4/76). CONCLUSION: The addition of nCLE to EUS-FNA significantly improves reliability of PCL diagnosis and could impact the therapeutic management of patients with single PCLs. ClinicalTrials.gov number, NCT01563133.

19 G nitinol needle versus 22 G needle for transduodenal endoscopic ultrasound-guided sampling of pancreatic solid masses: a randomized study.

BACKGROUND: The aim of this prospective multicenter study was to compare a flexible 19 G needle with nitinol shaft (19 G Flex) with a standard 22 G needle for transduodenal endoscopic ultrasound (EUS)-guided sampling of pancreatic head tumors. METHODS: Patients with pancreatic head tumors requiring tissue diagnosis were randomized into two arms: puncture with either a 19 G Flex needle or a 22 G needle. The primary end point was diagnostic accuracy for malignancy. The secondary end points were ergonomic scores, sample cytohistological quality, and complications. A 6-month follow-up was performed. RESULTS: 125 patients were randomized and 122 were analyzed: 59 patients in the 19 G Flex arm and 63 patients in the 22 G arm. The final diagnosis was malignancy in 111 patients and benign condition in 11. In intention-to-treat analysis, the diagnostic accuracy for malignancy of the 19 G Flex and 22 G needles was 69.5 % (95 % confidence interval [CI] 56.1 % - 80.8 %) vs. 87.3 % (95 %CI 76.5 % - 94.4 %), respectively (P = 0.02). In per-protocol analysis excluding eight technical failures in the 19 G Flex group, the diagnostic accuracy of the 19 G Flex and 22 G needles was not statistically different: 80.4 % (95 %CI 66.9 % - 90.2 %) vs. 87.3 % (95 %CI 76.5 % - 94.4 %; P = 0.12). Technical success was higher in the 22 G arm than in the 19 G Flex arm: 100 % (95 %CI 94.3 % - 100 %) vs. 86.4 % (95 %CI 75.0 % - 94.0 %), respectively (P = 0.003). Transduodenal EUS-guided sampling was more difficult with the 19 G Flex (odds ratio 0.68, 95 %CI 0.47 - 0.97). CONCLUSION : The 19 G Flex needle was inferior to a standard 22 G needle in diagnosing pancreatic head cancer and more difficult to use in the transduodenal approach.

Value of contrast-enhanced harmonic endoscopic ultrasonography with enhancement pattern for diagnosis of pancreatic cancer: A meta-analysis.

BACKGROUND: Current imaging modalities are limited in their ability to distinguish pancreatic cancer (PC) from non-neoplastic pancreatic lesions. The diagnostic use of contrast-enhanced endoscopic ultrasonography (CE-EUS) has increased, and its utility has been reported. Recently, contrast-enhanced harmonic EUS (CH-EUS) was reported to facilitate imaging of parenchymal perfusion and microvessels in pancreatobiliary diseases, leading to a high diagnostic accuracy for PC. The present meta-analysis aims to investigate the usefulness of CH-EUS with enhancement pattern for PC diagnosis. METHODS: A systematic meta-analysis of all potentially relevant articles identified in PubMed, the Cochrane library, and Medline was carried out. Fixed-effects or random-effects models were used to investigate pooled sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio with 95% confidence interval (CI). RESULTS: The study enrolled 887 patients from nine eligible studies. Pooled estimates of sensitivity and specificity were 93% (95% CI, 0.91-0.95) and 80% (95% CI, 0.75-0.85), respectively. Subgroup analyses were carried out on the main results after excluding two outliers. Area under summary receiver operating characteristics curve was 0.97. No publication bias was found using funnel plots. No significant relationship was found between the diagnostic odds ratios and the characteristics of the studies including continent and contrast agent. CONCLUSIONS: This meta-analysis showed that CH-EUS with qualitative analysis of enhancement pattern is useful for the diagnosis of PC, and has high sensitivity and accuracy, regardless of the type of contrast agent used. This modality may provide improved diagnostic accuracy for PC in clinical practice.

Chronic Genotype 3 Hepatitis E in Pregnant Woman Receiving Infliximab and Azathioprine.

Acute hepatitis E virus infection during pregnancy has a high fatality rate in developing countries. Little data are available on chronic infection in pregnant women. We report a case of chronic hepatitis E during treatment with infliximab and azathioprine, without adverse event during pregnancy and with spontaneous resolution after delivery.

Contrast harmonic EUS for the prediction of pancreatic neuroendocrine tumor aggressiveness (with videos).

BACKGROUND AND AIMS: Contrast harmonic EUS (CH-EUS) has the ability to depict tumor microvasculature. Decreased microvascular density has been identified as a factor associated with tumor aggressiveness. We aimed to study the accuracy of CH-EUS for the prediction of pancreatic neuroendocrine tumor (PNET) aggressiveness. METHODS: Between June 2009 and March 2015, all consecutive patients with histology-proven PNETs and CH-EUS examination were included. Nine endosonographers blindly analyzed all videos. CH-EUS tumor aggressiveness was defined as a heterogeneous enhancement at the early arterial phase. The final diagnosis of tumor aggressiveness was defined as follows: G3 tumors, morphologic and/or histologic findings of metastatic disease in G1/G2 tumors. Diagnostic values were calculated. Intratumoral microvascular density and fibrosis were assessed on pathologic specimens. RESULTS: Eighty-one tumors were included, of which 26 were aggressive (32.1%). In CH-EUS 35 tumors (43.2%) had a heterogeneous enhancement. The overall accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of CH-EUS for the diagnosis of tumor aggressiveness were 86%, 96%, 82%, 71%, and 98%, respectively. The interobserver agreement among the 9 endosonographers was good (k = .66). The intraobserver agreement was excellent for the junior (κ = .83) and senior (κ = .82) endosonographers. Heterogeneous tumors at CH-EUS corresponded to fewer vascular and more fibrotic tumors (P < .01). CONCLUSIONS: CH-EUS is accurate in the prediction of PNET aggressiveness and could be a decision-making element in their management.

Colon capsule versus computed tomography colonography for colorectal cancer screening in patients with positive fecal occult blood test who refuse colonoscopy: a randomized trial.

OBJECTIVE: Some patients (10 % - 32 %) with a positive guaiac fecal occult blood test (gFOBT) do not undergo the recommended colonoscopy. The aim of this study was to compare video capsule endoscopy (VCE) and computed tomography colonography (CTC) in terms of participation rate and detection outcomes when offered to patients with a positive gFOBT who did not undergo the recommended colonoscopy. METHODS: An invitation letter offering CTC or VCE was sent to selected patients after randomization. Acceptance of the proposed (or alternative) procedure and procedure results were recorded. Sample size was evaluated according to the hypothesis of a 13 % increase of participation with VCE. RESULTS: A total of 756 patients were targeted. Following the invitation letter, 5.0 % (19/378) of patients underwent the proposed VCE and 7.4 % (28/378) underwent CTC, (P = 0.18). Following the letter, 9.8 % (37/378) of patients in the VCE group underwent a diagnostic procedure (19 VCE, 1 CTC, 17 colonoscopy) vs. 10.8 % in the CTC group (41/378: 28 CTC, 13 colonoscopy; P = 0.55). There were more potentially neoplastic lesions diagnosed in the VCE group than in the CTC group (12/20 [60.0 %] vs. 8/28 [28.6 %]; P = 0.04). Thus, 15/20 noninvasive procedures in the VCE group (19 VCE, 1 CTC; 75.0 %) vs. 10/28 in the CTC group (35.7 %; P = 0.01) resulted in a recommendation of further colonoscopy, but only 10/25 patients actually underwent this proposed colonoscopy. CONCLUSION: Patients with a positive gFOBT result who do not undergo the recommended colonoscopy are difficult to recruit to the screening program and simply proposing an additional, less-invasive procedure, such as VCE or CTC, is not an effective strategy.ClinicalTrials.govNCT02558881TRIAL REGISTRATION: Randomized, controlled trial NCT02558881 at clinicaltrials.gov.

Can endoscopic papillectomy be curative for early ampullary adenocarcinoma of the ampulla of Vater?

BACKGROUND: The therapeutic role of endoscopic papillectomy (EP) for early ampullary cancer (AC) is still controversial. The aim of the present study was to evaluate the curative potential of EP for early AC and to identify predictors of lymph node metastases (LNMs). METHODS: We retrospectively reviewed 173 patients who were prospectively included in a database and who underwent EP between 1999 and 2013. Adenocarcinoma was present in 28 resected specimens. An additional surgery was proposed in cases of duodenal submucosal infiltration, duct ingrowth, R1 resection or lymphovascular invasion. Clinicopathological information and outcomes were collected, and predictors of LNMs were evaluated. RESULTS: Duodenal submucosal invasion was present in 16/28 cases and LNMs, in 9/28 cases. ACs of the biliopancreatic subtype were smaller (NS); 100 % had submucosal invasion, and 71 % had LNMs. Smaller tumour size, biliopancreatic subtype and submucosal invasion were significantly correlated with LNMs (p < 0.028, p < 0.028 and p < 0.014). Predictive factors of LNMs in the multivariate analysis were submucosal invasion and tumour size (OR 0.032, p < 0.023 and OR 0.711, p < 0.035). EP was curative in 100 % of cancers with R0 resection and no evidence of submucosal or lymphovascular invasion. CONCLUSION: EP may be curative for patients with AC limited to the duodenal mucosa or the sphincter of Oddi without lymphovascular invasion. Due to the presence of more invasive stages at diagnosis, EP may not be curative for ACs of the biliopancreatic subtype. The significance of tumour size is limited by other confounders, such as the histological subtype.

The clinical impact of ultrasound contrast agents in EUS: a systematic review according to the levels of evidence.

BACKGROUND AND AIMS: The use of contrast-harmonic EUS (CH-EUS) in routine clinical practice is increasing rapidly but is not yet standardized. We present the levels of evidence (LEs) found in the literature to put its clinical outcomes in the appropriate perspective. METHODS: We conducted a systematic review of the available English-language articles. The LEs were stratified according to the Oxford Centre for Evidence-Based Medicine guidelines. RESULTS: Overall, 210 articles were included and presented according to different pathologic conditions. For pancreatic solid neoplasms, the pooled sensitivity and specificity in the diagnosis of pancreatic carcinoma were very high (LE 1); quantitative analysis and guidance of FNA were reported as investigational research (LE 2-3). For pancreatic cystic lesions, the identification of neoplastic solid components as hyperenhanced lesions represented a promising application of CH-EUS (LE 2). For lymph nodes, CH-EUS increased the diagnostic yield of B-mode EUS for the detection of malignancy (LE 2). For submucosal tumors, CH-EUS seemed useful for differential diagnosis and risk stratification (LE 2-3). For other applications, differential diagnosis of gallbladder and vascular abnormalities by CH-EUS were reported (LE 2-3). CONCLUSIONS: The LEs of CH-EUS in the literature have evolved from the initial descriptive studies to multicenter and prospective trials, and even meta-analyses. The differential diagnosis between benign and malignant lesions is the main field of application of CH-EUS. With regard to pancreatic solid neoplasms, the concomitant use of both CH-EUS and EUS-FNA may have additive value in increasing the overall accuracy by overcoming the false-negative results associated with each individual technique. Other applications are promising but still investigational.

Endoscopic treatment of sporadic small duodenal and ampullary neuroendocrine tumors.

Background and study aim: As duodenal neuroendocrine tumors (NETs) are rare, their optimal management has not been clearly established. The aim of this study was to evaluate the feasibility and outcome of endoscopic treatment of duodenal NETs. Patients and methods: We reviewed the files of all patients who underwent endoscopic resection of a sporadic duodenal or ampullary NET between 1996 and 2014 at two centers. Results: A total of 29 patients with 32 uT1N0M0 NETs < 20 mm were included. Treatment consisted of endoscopic mucosal resection in 19 cases, and cap aspiration in 13 cases. Prior submucosal saline injection was used in 15 cases. Mortality was 3 % (one severe bleeding). Morbidity was 38 % (11/29). At post-resection analysis, mean tumor size was 8.9 mm (range 3 - 17 mm), 29 lesions were stage pT1, one was pT2, and 2 were pTx because of piecemeal resection. All NETs were well differentiated. A total of 27 lesions were classified as grade 1 and 5 were grade 2. The resection was R0, R1, and Rx for 16, 14, and 2 lesions, respectively. Three R1 patients underwent additional surgical treatment, with no residual tumor on the surgical specimen but with positive metastatic lymph nodes in two cases. One patient was lost to follow-up. Finally, 24 patients were included in the follow-up analysis. The median follow-up period was 56 months (range 6 - 175 months). Two patients presented a tumor recurrence during the follow-up period. Conclusions: Endoscopic treatment of small duodenal NETs was associated with significant morbidity, a difficulty in obtaining an R0 specimen, and the risk of lymph node metastasis. Nevertheless, it represents an interesting alternative in small grade 1 duodenal lesions and in patients at high surgical risk.

Prospective randomized comparison between axial- and lateral-viewing capsule endoscopy systems in patients with obscure digestive bleeding.

BACKGROUND AND STUDY AIM: Video capsule endoscopy (VCE) is recommended as the first exploration in obscure digestive bleeding. The efficiency of the PillCam SB2 (Given Imaging) has been widely reported. The CapsoCam capsule (Capsovision) has four cameras allowing the exploration of the small bowel through 360° lateral viewing. This system does not include a recording system so the capsule has to be retrieved by the patient after expulsion in order for the film to be downloaded. The aim of this study was to evaluate diagnostic concordance (kappa value) of the PillCam SB2 and CapsoCam capsules in the same patients. METHODS: This was a prospective comparative study in four French referral endoscopy units. Consecutive patients ingested the two capsules 1 hour apart and in a randomized order. RESULTS: In the 73 included patients there were 13 technical issues (11 CapsoCam, 2 PillCam SB2). Of the 60 patients with analyzable data, and following expert review of all discordant cases, a concordant positive diagnosis was obtained in 23 (38.3 %) and a negative diagnosis was obtained and 26 patients (43.3 %). Concordance was good, with a kappa value of 0.63 in analyzable patients, and 46.7 % diagnosis with CapsoCam vs. 48.3 % with PillCam SB2. CapsoCam and PillCam SB2 procedures identified 81.8 % (27 /33) and 84.8 % (28 /33) of positive patients, respectively (P = 0.791). In a per lesion analysis, the CapsoCam capsule detected significantly more lesions (108 vs. 85 lesions; P = 0.001). Reading time was longer for CapsoCam procedures (32.0 vs. 26.2 minutes; P = 0.002). CONCLUSION: This study shows comparable efficiency of the CapsoCam and PillCam SB2 capsule systems in terms of diagnostic yield and image quality.

Contrast-harmonic endoscopic ultrasound for the diagnosis of pancreatic adenocarcinoma: a prospective multicenter trial.

BACKGROUND AND STUDY AIMS: Histology is the gold standard for the diagnosis of pancreatic adenocarcinoma. However, the negative predictive value of endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) for the diagnosis remains low. The aims of this prospective multicenter study were: (1) to compare the performance of contrast-harmonic EUS (CH-EUS) with that of EUS-FNA for the diagnosis of pancreatic adenocarcinoma; (2) to assess the intra- and interobserver concordances of CH-EUS. PATIENTS AND METHODS: A total of 100 consecutive patients with a solid pancreatic mass of unknown origin were prospectively included at three centers (July 2009 - April 2010). All patients were examined by CH-EUS followed by EUS-FNA. Absence of vascular enhancement at CH-EUS was regarded as a sign for pancreatic adenocarcinoma. The final diagnosis (gold standard) was based on pathological examination (EUS-FNA, surgery) or 12-month follow-up.  RESULTS: The final diagnoses were: 69 adenocarcinoma, 10 neuroendocrine tumors, 13 chronic pancreatitis, and 8 other lesions. In diagnosing adenocarcinoma, CH-EUS and EUS-FNA had respective accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of 95 %, 96 %, 94 %, 97 %, and 91 %, and of 95 %, 93 %, 100 %, 100 %, and 86 % without significant difference. Five false-negative cases with EUS-FNA were correctly classified by CH-EUS. Interobserver agreement (seven endosonographers) was good (kappa 0.66). Intraobserver agreement was good to excellent (kappa 0.76 for junior, 0.90 for senior). CONCLUSIONS: The performance of CH-EUS for the diagnosis of pancreatic adenocarcinoma was excellent. The good intra- and interobserver concordances suggest an excellent reproducibility. CH-EUS could help to guide the choice between surgery and follow-up when EUS-FNA is inconclusive.