EUS-guided entero-colostomy with Lumen Apposing Metal Stent as a rescue treatment for malignant intestinal occlusion: a multicentre study.

BACKGROUND AND STUDY AIMS: Surgery is the first-choice treatment for malignant intestinal obstruction (MIO), however many patients are deemed unfit for surgery. Endoscopic ultrasound guided enterocolostomy (EUS-EC) with lumen apposing metal stents (LAMS) could represent a new treatment option. Primary aim was technical success of EUS-EC. Secondary aims: clinical outcome, safety, hospital stay. PATIENTS AND METHODS: Consecutive patients undergoing EUS-EC for MIO from November 2021 to September 2023 were retrospectively enrolled at four tertiary referral European centres. All cases were discussed in multidisciplinary meetings, patients declared unfit for surgery, colonic stent placement or refused surgery. RESULTS: Twelve patients were enrolled (58.3% female, median age 72.5 [42-85]). Colonic adenocarcinoma was the primary tumor in 75% of cases and 91.7% of patients had a Stage IV disease. Technical success was achieved in all procedures (100%). No LAMS misdeployment or other procedural adverse events and 3 (25%) severe post-procedural complications were observed. Clinical success was achieved in 10 (83.3%) patients, 5 (50%) resuming chemotherapy after procedure. Median post-procedural hospital stay was 9[1-20] days and overall median survival was 47.5[2-270] days. CONCLUSIONS: EUS-EC is a feasible technique and could be considered as a possible alternative to standard approaches for MIO in highly selected patients.

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.

Safety and efficacy of endoscopic ultrasound-guided radiofrequency ablation for pancreatic neuroendocrine neoplasms: Systematic review and meta-analysis.

OBJECTIVE: Endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) has been constantly increasing, particularly in the treatment of pancreatic neuroendocrine neoplasms (pNENs). While emerging data in this field are accumulating, we aimed to assess the pooled efficacy and safety of EUS-RFA for pNENs. METHODS: The PubMed/Medline, Embase, and Cochrane Library databases search was conducted to identify studies reporting EUS-RFA of pNENs with outcomes of interest (efficacy and safety). The primary outcome was radiological response. Efficacy was assessed by the pooled clinical response rate, whereas safety was assessed by the pooled adverse events (AEs) rate. Heterogeneity was assessed using I2. Pooled estimates and the 95% confidence interval (CI) were calculated using a random-effect model. RESULTS: Eleven studies involving 292 patients were included. The pooled technical success rate was 99.2% (95% CI 97.9-99.9%), with no heterogeneity. The pooled complete radiological response was 87.1% (95% CI 80.1-92.8%). The pooled partial response was 11.4% (95% CI 6.2-18.1%). The pooled clinical response rate for functional pNENs was 94.9% (95% CI 90.7-97.9%), with no heterogeneity. The pooled incidence of AEs was 20.0% (95% CI 14.0-26.7%); most AEs were mild to moderate in grade, while the pooled incidence of severe AEs was 0.9% (95% CI 0.2-2.3%). The most common AEs were transient mild abdominal pain in 19 patients (6.5%), and mild to moderate pancreatitis in 23 patients (7.9%). No cases of mortality were reported. CONCLUSION: Endoscopic ultrasound-guided radiofrequency ablation resulted on a feasible approach for pNENs treatment, with excellent technical success, high radiological and clinical response, and acceptable AE rate.

Risk factors for EUS-guided radiofrequency ablation adverse events in patients with pancreatic neoplasms: a large national French study (RAFPAN study).

BACKGROUND AND AIMS: EUS-guided radiofrequency ablation (EUS-RFA) has been described as a potentially curative option for solid and cystic pancreatic neoplasms. We aimed to assess the safety and efficacy of pancreatic EUS-RFA in a large study population. METHODS: A retrospective study retrieving all consecutive patients who underwent pancreatic EUS-RFA during 2019 and 2020 in France was conducted. Indication, procedural characteristics, early and late adverse events (AEs), and clinical outcomes were recorded. Risk factors for AEs and factors related to complete tumor ablation were assessed on univariate and multivariate analyses. RESULTS: One hundred patients (54% men, 64.8 ± 17.6 years old) affected by 104 neoplasms were included. Sixty-four neoplasms were neuroendocrine neoplasms (NENs), 23 were metastases, and 10 were intraductal papillary mucinous neoplasms with mural nodules. No procedure-related mortality was observed, and 22 AEs were reported. Proximity of pancreatic neoplasms (≤1 mm) to the main pancreatic duct was the only independent risk factor for AEs (odds ratio [OR), 4.10; 95% confidence interval [CI), 1.02-15.22; P = .04). Fifty-nine patients (60.2%) achieved a complete tumor response, 31 (31.6%) a partial response, and 9 (9.2%) achieved no response. On multivariate analysis, NENs (OR, 7.95; 95% CI, 1.66-51.79; P < .001) and neoplasm size <20 mm (OR, 5.26; 95% CI, 2.17-14.29; P < .001) were independently related to complete tumor ablation. CONCLUSIONS: The results of this large study confirm an overall acceptable safety profile for pancreatic EUS-RFA. Close proximity (≤1 mm) to the main pancreatic duct represents an independent risk factor for AEs. Good clinical outcomes in terms of tumor ablation were observed, especially for small NENs.

Wet-suction versus slow-pull technique for endoscopic ultrasound-guided fine-needle biopsy: a multicenter, randomized, crossover trial.

BACKGROUND : It is unknown whether there is an advantage to using the wet-suction or slow-pull technique during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) with new-generation needles. We aimed to compare the performance of each technique in EUS-FNB. METHODS: This was a multicenter, randomized, single-blind, crossover trial including patients with solid lesions of ≥ 1 cm. Four needle passes with 22 G fork-tip or Franseen-type needles were performed, alternating the wet-suction and slow-pull techniques in a randomized order. The primary outcome was the histological yield (samples containing an intact piece of tissue of at least 550 µm). Secondary end points were sample quality (tissue integrity and blood contamination), diagnostic accuracy, and adequate tumor fraction. RESULTS: Overall, 210 patients with 146 pancreatic and 64 nonpancreatic lesions were analyzed. A tissue core was retrieved in 150 (71.4 %) and 129 (61.4 %) cases using the wet-suction and the slow-pull techniques, respectively (P = 0.03). The mean tissue integrity score was higher using wet suction (P = 0.02), as was the blood contamination of samples (P < 0.001). In the two subgroups of pancreatic and nonpancreatic lesions, tissue core rate and tissue integrity score were not statistically different using the two techniques, but blood contamination was higher with wet suction. Diagnostic accuracy and tumor fraction did not differ between the two techniques. CONCLUSION: Overall, the wet-suction technique in EUS-FNB resulted in a higher tissue core procurement rate compared with the slow-pull method. Diagnostic accuracy and the rate of samples with adequate tumor fraction were similar between the two techniques.

Left colonic localization, non-granular morphology, and pit pattern independently predict submucosal fibrosis of naïve colorectal neoplasms before endoscopic submucosal dissection.

BACKGROUND: Endoscopic submucosal dissection (ESD) represents the method of choice for removal of large colorectal neoplasms with suspected submucosal invasion. Presence and degree of submucosal fibrosis increases ESD duration and technical complexity, reduces the rate of curative resection and reduces safety profile. The aim of the study was to identify pre-procedural predictive factors of submucosal fibrosis in naïve colorectal neoplasms and to assess the impact of fibrosis on technical and clinical ESD outcomes. METHODS: All consecutive ESD performed between 2014 and 2021 were retrieved from a prospectively collected database. For each patient, pre-procedural, procedural, and post-procedural data were recorded. Logistic regression was used to identify pre-procedural predictive factors for submucosal fibrosis. The study was approved by Institutional Reviewer Board and registered on ClinicalTrials.gov (NCT04780256). RESULTS: One hundred-74 neoplasms (46.6% rectum, 21.8% left colon, 31.6% right colon; size 34.9 ± 17.5 mm) from 169 patients (55.0% male; 69.5 ± 10.4-year-old) were included. 106 (60.9%) neoplasms were granular type laterally spreading tumor (LST-G), 42 (24.1%) non-granular (LST-NG), and 26 (14.9%) sessile; invasive pit pattern was observed in 90 (51.7%) lesions. No fibrosis (F0) mild (F1) and severe (F2) were observed in 62 (35.6%), 92 (52.9%), and 20 (11.5%), respectively. Left colonic localization [OR 3.23 (1.1-9.31)], LST-NG morphology [OR 5.84 (2.03-16.77)] and invasive pit pattern [OR 7.11 (3.11-16.23)] were independently correlated to submucosal fibrosis. Lower curative resection rate (59.8% vs. 93.5%, P < 0.001) was observed in case of fibrosis; the incidence of adverse events was higher in case of severe fibrosis (35.5%) compared to no (3.2%) and mild fibrosis (3.3%; P < 0.001). Procedure time was significantly impacted by presence and degree of fibrosis (P < 0.001). CONCLUSIONS: Left colonic localization, LST-NG morphology, and invasive pit pattern are independent predictors of fibrosis, affecting technical and clinical ESD outcomes. Pre-procedural stratification is pivotal to estimate procedure time, required operator's experience and advanced dissection techniques. Cecinato P et al. Left colonic localization, non-granular morphology, and pit pattern independently predict submucosal fibrosis of colorectal neoplasms before endoscopic submucosal dissection. Surg Endosc. 2023.

Repeated endoscopic ultrasound-guided fine-needle biopsy of solid pancreatic lesions after previous nondiagnostic or inconclusive sampling.

OBJECTIVES: Repeated endoscopic ultrasound (EUS)-guided tissue acquisition represents the standard practice for solid pancreatic lesions after previous nondiagnostic or inconclusive results. Since data are lacking, we aimed to evaluate the diagnostic performance of repeated EUS fine-needle biopsy (rEUS-FNB) in this setting. The primary outcome was diagnostic accuracy; sample adequacy, sensitivity, specificity, and safety were secondary outcomes. METHODS: Consecutive patients undergoing rEUS-FNB for solid pancreatic lesions at 23 Italian centers from 2019 to 2021 were retrieved. Pathology on the surgical specimen, malignant histology together with ≥6-month follow-up, and benign pathology together with ≥12-month follow-up were adopted as gold standards. RESULTS: Among 462 patients, 56.5% were male, with a median age of 68 (59-75) years, malignancy prevalence 77.0%. Tumor size was 26 (20-35) mm. Second-generation FNB needles were used in 89.6% cases. Diagnostic accuracy, sensitivity, and specificity of rEUS-FNB were 89.2%, 91.4%, and 81.7%, respectively (19 false-negative and 12 false-positive results). On multivariate analysis, rEUS-FNB performed at high-volume centers (odds ratio [OR] 2.12; 95% confidence interval [CI] 1.10-3.17; P = 0.03) and tumor size (OR 1.03; 95% CI 1.00-1.06; P = 0.05) were independently related to diagnostic accuracy. Sample adequacy was 94.2%. Use of second-generation FNB needles (OR 5.42; 95% CI 2.30-12.77; P < 0.001) and tumor size >23 mm (OR 3.04; 95% CI 1.31-7.06; P = 0.009) were independently related to sample adequacy. CONCLUSION: Repeated EUS-FNB allowed optimal diagnostic performance after nondiagnostic or inconclusive results. Patients' referral to high-volume centers improved diagnostic accuracy. The use of second-generation FNB needles significantly improved sample adequacy over standard EUS-FNB needles.

Comparative diagnostic performance of end-cutting fine-needle biopsy needles for EUS tissue sampling of solid pancreatic masses: a network meta-analysis.

BACKGROUND AND AIMS: Evidence is limited on the comparative diagnostic performance of newer end-cutting fine-needle biopsy (FNB) needles for tissue sampling of pancreatic masses. We performed a systematic review with network meta-analysis to compare the diagnostic accuracy of available FNB needles for sampling of solid pancreatic lesions. METHODS: A systematic literature review (Medline and Cochrane Database) was conducted for studies evaluating the accuracy of newer FNB needles in adults undergoing EUS-guided sampling of solid pancreatic masses. The primary outcome was diagnostic accuracy. Secondary outcomes were sample adequacy, diagnostic sensitivity, specificity, and adverse event rate. We performed pairwise and network meta-analyses and appraised the quality of evidence using Grading of Recommendations Assessment, Development and Evaluation methodology. RESULTS: Overall, 16 RCTs (1934 patients) were identified. On network meta-analysis, Franseen needles (Acquire; Boston Scientific, Marlborough, Mass, USA) significantly outperformed reverse-bevel needles (risk ratio [RR], 1.21 [95% confidence interval {CI}, 1.05-1.40] for accuracy and 1.31 [95% CI, 1.05-1.22] for adequacy) and FNA needles (RR, 1.21 [95% CI, 1.01-1.25] for accuracy and 1.07 [95% CI, 1.02-1.13] for adequacy). Likewise, the Fork-tip needle (SharkCore; Medtronic, Dublin, Ireland) was significantly superior to the reverse-bevel needle (RR, 1.17 [95% CI, 1.03-1.33] for accuracy and 1.09 [95% CI, 1.02-1.16] for adequacy) and to the FNA needle (RR, 1.09 [95% CI, 1.01-1.19] for accuracy and 1.03 [95% CI, 1.01-1.07] for adequacy). Other comparisons did not achieve statistical significance. As a consequence, Franseen (surface under the cumulative ranking score, .89 for accuracy and .94 for adequacy) and Fork-tip needles (surface under the cumulative ranking score, .76 for accuracy and .73 for adequacy) ranked as the 2 highest-performing FNB needles. When considering different needle sizes, 25-gauge Franseen and 25-gauge Fork-tip needles were not superior to 22-gauge reverse-bevel needles (RR, 1.18 [95% CI, .96-1.46] and 1.04 [95% CI, .62-1.52]). None of the tested needles was significantly superior to the other FNB devices or to FNA needles when rapid onsite cytologic evaluation was available. CONCLUSIONS: Franseen and Fork-tip needles, particularly 22-gauge size, showed the highest performance for tissue sampling of pancreatic masses, with low confidence in estimates.

The endoscopic ultrasound features of pancreatic fluid collections and their impact on therapeutic decisions: an interobserver agreement study.

BACKGROUND: A validated classification of endoscopic ultrasound (EUS) morphological characteristics and consequent therapeutic intervention(s) in pancreatic and peripancreatic fluid collections (PFCs) is lacking. We performed an interobserver agreement study among expert endosonographers assessing EUS-related PFC features and the therapeutic approaches used. METHODS: 50 EUS videos of PFCs were independently reviewed by 12 experts and evaluated for PFC type, percentage solid component, presence of infection, recognition of and communication with the main pancreatic duct (MPD), stent choice for drainage, and direct endoscopic necrosectomy (DEN) performance and timing. The Gwet's AC1 coefficient was used to assess interobserver agreement. RESULTS: A moderate agreement was found for lesion type (AC1, 0.59), presence of infection (AC1, 0.41), and need for DEN (AC1, 0.50), while fair or poor agreements were stated for percentage solid component (AC1, 0.15) and MPD recognition (AC1, 0.31). Substantial agreement was rated for ability to assess PFC-MPD communication (AC1, 0.69), decision between placing a plastic versus lumen-apposing metal stent (AC1, 0.62), and timing of DEN (AC1, 0.75). CONCLUSIONS: Interobserver agreement between expert endosonographers regarding morphological features of PFCs appeared suboptimal, while decisions on therapeutic approaches seemed more homogeneous. Studies to achieve standardization of the diagnostic endosonographic criteria and therapeutic approaches to PFCs are warranted.

EUS-guided gallbladder drainage in high-risk surgical patients with acute cholecystitis-procedure outcomes and evaluation of mortality predictors.

BACKGROUND: Recent evidences suggest that gallbladder drainage is the treatment of choice in elderly or high-risk surgical patients with acute cholecystitis (AC). Despite better outcomes compared to other approaches, endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) is burdened by high mortality. The aim of the study was to evaluate predictive factors for mortality in high-risk surgical patients who underwent EUS-GBD for AC. METHODS: A retrospective analysis of a prospectively maintained database was performed. Electrocautery-enhanced lumen-apposing metal stents were used; all recorded variables were evaluated as potential predictive factors for mortality. RESULTS: Thirty-four patients underwent EUS for suspected AC and 25 (44% male, age 78) were finally included. Technical, clinical success rate and adverse events rate were 92%, 88%, and 16%, respectively. 30-day and 1-year mortality were 12% and 32%. On univariate analysis, age-adjusted Charlson Comorbidity Index (CCI) (OR 20.8[4-68.2]), acute kidney injury (AKI) (OR 21.4[2.6-52.1]) and clinical success (OR 8.9[1.2-11.6]) were related to 30-day mortality. On multivariate analysis, CCI and AKI were independently related to long-term mortality. Kaplan-Meier curves showed an increased long-term mortality in patients with CCI > 6 (hazard ratio 7.6[1.7-34.6]) and AKI (hazard ratio 11.3[1.4-91.5]). CONCLUSIONS: Severe comorbidities and AKI were independent predictive factors confirming of long-term mortality after EUS-GBD. Outcomes of EUS-GBD appear more influenced by patients' conditions rather than by procedure success.

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.

Evaluation of the performances of a single-use duodenoscope: Prospective multi-center national study.

OBJECTIVES: A single-use duodenoscope (SUD) has been recently developed to overcome issues with endoscopic retrograde cholangiopancreatography (ERCP)-related cross-infections. The aim was to evaluate SUD safety and performance in a prospective multi-centre study. METHODS: All consecutive patients undergoing ERCP in six French centers were prospectively enrolled. All procedures were performed with the SUD; in case of ERCP failure, operators switched to a reusable duodenoscope. Study outcomes were the successful completion of the procedure with SUD, safety and operators' satisfaction based on a VAS 0-10 and on 22 qualitative items. The study protocol was approved by French authorities and registered (ID-RCB: 2020-A00346-33). External companies collected the database and performed statistical analysis. RESULTS: Sixty patients (34 females, median age 65.5 years old) were enrolled. Main indications were bile duct stones (41.7%) and malignant biliary obstruction (26.7%). Most ERCP were considered ASGE grade 2 (58.3%) or 3 (35.0%). Fifty-seven (95.0%) procedures were completed using the SUD. Failures were unrelated to SUD (one duodenal stricture, one ampullary infiltration, and one tight biliary stricture) and could not be completed with reusable duodenoscopes. Median operators' satisfaction was 9 (7-9). Qualitative assessments were considered clinically satisfactory in a median of 100% of items and comparable to a reusable duodenoscope in 97.9% of items. Three patients (5%) reported an adverse event. None was SUD-related. CONCLUSIONS: The use of a SUD allows ERCP to be performed with an optimal successful rate. Our data show that SUD could be used for several ERCP indications and levels of complexity.

Perceived Feasibility of Endoscopic Ultrasound-Guided Gastroenteric Anastomosis: An Italian Survey.

Background and Objectives: Endoscopic ultrasound-guided gastroenteric anastomosis (EUS-GEA) using lumen-apposing metal stents (LAMS) is emerging as a minimally invasive alternative to surgery across several indications. The aim of this survey is to investigate the perceived feasibility of this technique nationwide, within a working group skilled in interventional endosonography. Materials and Methods: Endoscopists were asked to answer to 49 items on a web-based questionnaire about expertise, peri- and intra-procedural aspects in the three main settings of EUS-GEA performance, budget/refund, and future perspectives. Statistical analysis was performed through SPSS® (IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: IBM Corp.). Results: Sixty endosonographers belonging to forty Italian centers were I-EUS app users and were all invited to participate. In total, 29 participants from 24 Italian centers completed the survey. All the participants were endosonographers with a broad range of experience both in the field of EUS (only 10.3% with more than 20 years of experience) and duodenal stenting (only 6.9% placed more than 10 stents in 2020), whereas 86.2% also performed ERCP. A total of 27.6% of participants performed EUS-GEA (3.4% more than 20 during their career); on the other hand, 79.3% of participants routinely performed drainage of peri-pancreatic fluid collections, 62.1% performed biliary drainage, and 62.1% performed gallbladder drainage with LAMS. A total of 89.7% of participants thought that EUS-GEA could be useful in their daily clinical practice, with 100% concluding that this procedure will need to be performed in referral centers in the near future; however, in 55.2% of cases, organizational obstacles may occur and affect the diffusion of the procedure. With regard to indications: 44.8% of participants performed the procedure with palliative intent for malignant indication (96.6% pancreatic adenocarcinoma), and 13.6% also for benign indication. A total of 20.7% of participants experienced adverse events (none severe or fatal, 66.6% moderate). A total of 62.1% of participants considered the procedure technically challenging, although 82.8% considered the risk of adverse events acceptable when considering the benefit. Conclusions: To our knowledge, this is the first survey assessing the perceived feasibility of EUS-guided anastomoses after its advent. There are currently wide variations in practice nationwide, which demonstrate a need to define technical, qualitative, and peri-procedural requirements to carry out this procedure. Therefore, a standardization of these requirements is needed in order to overcome the technical, economical, and organizational obstacles relative to its diffusion.

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.

Effectiveness and safety of underwater techniques in gastrointestinal endoscopy: a comprehensive review of the literature.

BACKGROUND: Conventional endoscopic resection techniques such as endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD), represent the standard of care for treatment of superficial gastrointestinal lesions. In 2012 a novel technique called underwater endoscopic mucosal resection (U-EMR) was described by Binmoeller and colleagues. This substantial variation from the standard procedure was afterwards applied at endoscopic submucosal dissection (U-ESD) and recently proposed also for peroral endoscopic myotomy (U-POEM) and endoscopic full-thickness resection (U-EFTR). METHODS: This paper aims to perform a comprehensive review of the current literature related to supporting the underwater resection techniques with the aim to evaluate their safety and efficacy. RESULTS: Based on the current literature U-EMR appears to be feasible and safe. Comparison studies showed that U-EMR is associated with higher "en-bloc" and R0 resection rates for colonic lesions, but lower "en-bloc" and R0 resection rates for duodenal non-ampullary lesions, compared to standard EMR. In contrast to U-EMR, little evidence supporting U-ESD are currently available. A single comparison study on gastric lesions showed that U-ESD had shorter procedural times and allowed a similar "en-bloc" resection rates compared to standard ESD. No comparison studies between U-ESD and ESD are available for colonic lesions. Finally, only some anecdotal experiences have been reported for U-POEM or U-EFTR, and the feasibility and effectiveness of these techniques need to be further investigated. CONCLUSIONS: Further prospective studies are necessary to better explore the advantages of underwater techniques compared to the respective standards of care, especially in the setting of U-ESD where consistent data are lacking and where standardization of the technique is needed.

EUS and ERCP in the Same Session for Biliary Stones: From Risk Stratification to Treatment Strategy in Different Clinical Conditions.

Endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy and stone extraction is the treatment of choice for choledocholithiasis, reaching a successful clearance of the common bile duct (CBD) in up to 90% of the cases. Endoscopic ultrasound (EUS) has the best diagnostic accuracy for CBD stones, its sensitivity and specificity range being 89-94% and 94-95%, respectively. Traditionally seen as two separate entities, the two worlds of EUS and ERCP have recently come together under the new discipline of bilio-pancreatic endoscopy. Nevertheless, the complexity of both EUS and ERCP led the European Society of Gastrointestinal Endoscopy to identify quality in endoscopy as a top priority in its recent EUS and ERCP curriculum recommendations. The clinical benefits of performing EUS and ERCP in the same session are several, such as benefiting from real-time information from EUS, having one single sedation for both the diagnosis and the treatment of biliary stones, reducing the risk of cholangitis/acute pancreatitis while waiting for ERCP after the EUS diagnosis, and ultimately shortening the hospital stay and costs while preserving patients' outcomes. Potential candidates for the same session approach include patients at high risk for CBD stones, symptomatic individuals with status post-cholecystectomy, pregnant women, and those unfit for surgery. This narrative review discusses the main technical aspects and evidence from the literature about EUS and ERCP in the management of choledocholithiasis.

Repeat EUS-FNA of pancreatic masses after nondiagnostic or inconclusive results: systematic review and meta-analysis.

BACKGROUND AND AIMS: EUS-guided FNA (EUS-FNA) is the criterion standard for the diagnosis of solid pancreatic lesions. Several studies assessed the role of repeat EUS-FNA (rEUS-FNA) after an inconclusive examination. Our aim was to evaluate the pooled diagnostic accuracy of rEUS-FNA after a nondiagnostic result. METHODS: We conducted systematic research on electronic databases (Medline, PubMed, EMBASE) and a meta-analysis to obtain pooled sensitivity, specificity, positive and negative likelihood ratio, and diagnostic odds ratio. A summary receiver operating characteristic curve was used to calculate area under the curve. Subgroup analysis was used to assess the role of rapid on-site evaluation (ROSE). RESULTS: Twelve studies (505 patients) were included. Sensitivity was 77% (66%-86%), specificity 98% (78%-100%), and positive and negative predictive values 99% (98%-100%) and 61 (60%-63%), respectively. At 73% of disease prevalence (pretest probability), positive rEUS-FNA increased the disease probability to 99%, whereas a negative result decreased the disease probability to 39%. The sensitivity was 83% (64%-93%) and specificity 98% (80%-100%) when ROSE was available and 65% (57%-73%) and 94% (31%-100%) when not available. The number needed to diagnose was 1.2 (1.1-2.3) and 1.7 (1.4-8.3) in ROSE-positive and ROSE-negative cases, respectively. The number of correctly diagnosed cases increased from 6 (1-7) to 8 (4-9) of 10 patients without and with ROSE, respectively. CONCLUSIONS: This study objectively substantiated the added value of rEUS-FNA for the diagnosis of solid pancreatic masses in cases of a previous nondiagnostic or inconclusive result. Moreover, our data suggested that ROSE may be beneficial in this setting, because it increased the proportion of definitive diagnoses.