Combination of Mucosa-Exposure Device and Computer-Aided Detection for Adenoma Detection During Colonoscopy: A Randomized Trial.

BACKGROUND & AIMS: Both computer-aided detection (CADe)-assisted and Endocuff-assisted colonoscopy have been found to increase adenoma detection. We investigated the performance of the combination of the 2 tools compared with CADe-assisted colonoscopy alone to detect colorectal neoplasias during colonoscopy in a multicenter randomized trial. METHODS: Men and women undergoing colonoscopy for colorectal cancer screening, polyp surveillance, or clincial indications at 6 centers in Italy and Switzerland were enrolled. Patients were assigned (1:1) to colonoscopy with the combinations of CADe (GI-Genius; Medtronic) and a mucosal exposure device (Endocuff Vision [ECV]; Olympus) or to CADe-assisted colonoscopy alone (control group). All detected lesions were removed and sent to histopathology for diagnosis. The primary outcome was adenoma detection rate (percentage of patients with at least 1 histologically proven adenoma or carcinoma). Secondary outcomes were adenomas detected per colonoscopy, advanced adenomas and serrated lesions detection rate, the rate of unnecessary polypectomies (polyp resection without histologically proven adenomas), and withdrawal time. RESULTS: From July 1, 2021 to May 31, 2022, there were 1316 subjects randomized and eligible for analysis; 660 to the ECV group, 656 to the control group). The adenoma detection rate was significantly higher in the ECV group (49.6%) than in the control group (44.0%) (relative risk, 1.12; 95% CI, 1.00-1.26; P = .04). Adenomas detected per colonoscopy were significantly higher in the ECV group (mean ± SD, 0.94 ± 0.54) than in the control group (0.74 ± 0.21) (incidence rate ratio, 1.26; 95% CI, 1.04-1.54; P = .02). The 2 groups did not differ in term of detection of advanced adenomas and serrated lesions. There was no significant difference between groups in mean ± SD withdrawal time (9.01 ± 2.48 seconds for the ECV group vs 8.96 ± 2.24 seconds for controls; P = .69) or proportion of subjects undergoing unnecessary polypectomies (relative risk, 0.89; 95% CI, 0.69-1.14; P = .38). CONCLUSIONS: The combination of CADe and ECV during colonoscopy increases adenoma detection rate and adenomas detected per colonoscopy without increasing withdrawal time compared with CADe alone. CLINICALTRIALS: gov, Number: NCT04676308.

Endoscopic ultrasound-guided entero-colostomy with lumen-apposing metal stent as a rescue treatment for malignant intestinal occlusion: a multicenter study.

BACKGROUND: Surgery is the first-choice treatment for malignant intestinal obstruction (MIO); however, many patients are deemed unfit for surgery. Endoscopic ultrasound-guided entero-colostomy (EUS-EC) with a lumen-apposing metal stent (LAMS) could represent a new treatment option. METHODS: Consecutive patients undergoing EUS-EC for MIO from November 2021 to September 2023 at four European tertiary referral centers were retrospectively enrolled. Multidisciplinary meetings determined whether patients were unsuitable for surgery or colonic stent placement, or refused surgery. The primary outcome was technical success of EUS-EC and secondary outcomes were clinical outcome, safety, and hospital stay. RESULTS: 12 patients were enrolled (median age 72.5 [range 42-85] years; 58.3% female). Colonic adenocarcinoma was the primary tumor in 75.0% of patients and 91.7% had stage IV disease. Technical success was 100%. No LAMS misdeployment or other procedural adverse events occurred; three patients (25.0%) had severe post-procedural complications. Clinical success was achieved in 10 patients (83.3%), with 5 (50.0%) resuming chemotherapy after the procedure. Median post-procedural hospital stay was 9 (1-20) days and median overall survival was 47.5 (2-270) days. CONCLUSIONS: EUS-EC was a feasible technique and could be considered a possible alternative to standard approaches for MIO in highly selected patients.

Comparative diagnostic yield of different endoscopic techniques for tissue sampling of upper gastrointestinal subepithelial lesions: a network meta-analysis.

BACKGROUND: There is limited evidence on the comparative diagnostic performance of endoscopic tissue sampling techniques for subepithelial lesions. We performed a systematic review with network meta-analysis to compare these techniques. METHODS: A systematic literature review was conducted for randomized controlled trials (RCTs) comparing the sample adequacy and diagnostic accuracy of bite-on-bite biopsy, mucosal incision-assisted biopsy (MIAB), endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), and EUS-guided fine-needle biopsy (FNB). Results were expressed as relative risk (RR) and 95%CI. RESULTS: Eight RCTs were identified. EUS-FNB was significantly superior to EUS-FNA in terms of sample adequacy (RR 1.20 [95%CI 1.05-1.45]), whereas none of the other techniques significantly outperformed EUS-FNA. Additionally, bite-on-bite biopsy was significantly inferior to EUS-FNB (RR 0.55 [95%CI 0.33-0.98]). Overall, EUS-FNB appeared to be the best technique (surface under cumulative ranking [SUCRA] score 0.90) followed by MIAB (SUCRA 0.83), whereas bite-on-bite biopsy showed the poorest performance. When considering lesions <20 mm, MIAB, but not EUS-FNB, showed significantly higher accuracy rates compared with EUS-FNA (RR 1.68 [95%CI 1.02-2.88]). Overall, MIAB ranked as the best intervention for lesions <20 mm (SUCRA score 0.86 for adequacy and 0.91 for accuracy), with EUS-FNB only slightly superior to EUS-FNA. When rapid on-site cytological evaluation (ROSE) was available, no difference between EUS-FNB, EUS-FNA, and MIAB was observed. CONCLUSION: EUS-FNB and MIAB appeared to provide better performance, whereas bite-on-bite sampling was significantly inferior to the other techniques. MIAB seemed to be the best option for smaller lesions, whereas EUS-FNA remained competitive when ROSE was available.

ENDOLUMINAL RADIOFREQUENCY ABLATION WITH STENTING VS STENTING ONLY IN PATIENTS WITH MALIGNANT BILIARY OBSTRUCTION: A META-ANALYSIS OF RANDOMISED TRIALS.

INTRODUCTION: Endoluminal radiofrequency ablation (RFA) is a palliative treatment for patients suffering from malignant biliary obstruction. We aimed to conduct a meta-analysis to evaluate the impact of RFA on stent patency, patient survival, and adverse events. METHODS: Major databases were searched through November 2023 for patients who underwent stenting with or without RFA for extra-hepatic malignant biliary obstruction. A random effects model was employed for analysis and results conveyed using relative risk ratio with 95% confidence interval. RESULTS: Nine RCTs involving 750 subjects (n=374 RFA plus stent vs. n=376 stent only) with malignant biliary obstruction were included. Meta-analysis revealed similar risks of stent patency at 3 months (RR = 1.01; 95% CI [0.92 - 1.11], I2=4% for RFA plus stenting vs. stent only). Meta-analysis showed improved survival at 6 months (RR = 0.84; 95% CI [0.73 - 0.96], I2=21%, P=0.01 for RFA plus stenting vs. stent only). Subgroup analysis comparing plastic vs uncovered metal stents showed that stent patency was unaffected at 3 months (RR = 1.06; 95% CI [0.91 - 1.23]; I2=17%). Subgroup analysis showed that patients with cholangiocarcinoma experienced an overall survival benefit with RFA plus stenting vs. stent only (P<0.001), however, stent patency remained unaffected (P=0.08). An increased incidence of cholecystitis was noted with RFA plus stent vs. stent only (5.1%; 95% CI [3.1% - 7.8%] vs 0.3%; 95% CI [0.01% - 1.5%], respectively). CONCLUSION: Combining endoluminal RFA and stenting may improve overall survival in patients with malignant biliary obstruction. RFA did not impact stent patency significantly.

Lumen-apposing metal stents for the treatment of pancreatic and peripancreatic fluid collections and bleeding risk: a propensity matched study.

INTRODUCTION: Endoscopic ultrasound (EUS)-guided drainage of symptomatic pancreatic fluid collections (PFCs) using the Hot-Axios device has recently been associated with a significant risk of bleeding. This adverse event (AE) seems to occur less frequently with the use of a different device, the Spaxus stent. The aim of the current study was to compare the rates of bleeding between the two stents. METHODS: Patients admitted for treatment of PFCs by EUS plus lumen-apposing metal stent in 18 endoscopy referral centers between 10 July 2019 and 28 February 2022 were identified and their outcomes compared using a propensity-matching analysis. RESULTS: 363 patients were evaluated. After a 1-to-1 propensity score match, 264 patients were selected (132 per group). The technical and clinical success rates were comparable between the two groups. Significantly more bleeding requiring transfusion and/or intervention occurred in the Hot-Axios group than in the Spaxus group (6.8% vs. 1.5%; P = 0.03); stent type was a significant predictor of bleeding in both univariate and multivariate regression analyses (P = 0.03 and 0.04, respectively). Bleeding necessitating arterial embolization did not however differ significantly between the two groups (3.0% vs. 0%; P = 0.12). In addition, the Hot-Axios was associated with a significantly higher rate of overall AEs compared with the Spaxus stent (9.8% vs. 3.0%; P = 0.04). CONCLUSION: Our study showed that, in patients with PFCs, bleeding requiring transfusion and/or intervention occurred significantly more frequently with use of the Hot-Axios stent than with the Spaxus stent, although this was not the case for bleeding requiring embolization.

Endoscopic ultrasound-guided gallbladder drainage as a first approach for jaundice palliation in unresectable malignant distal biliary obstruction: Prospective study.

OBJECTIVES: Endoscopic retrograde cholangiopancreatography (ERCP) represents the gold standard for jaundice palliation in patients with distal malignant biliary obstruction (DMBO). Biliary drainage using electrocautery lumen apposing metal stent (EC-LAMS) is currently a well-established procedure when ERCP fails. In a palliative setting the endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) could represent an easy and valid option. We performed a prospective study with a new EC-LAMS with the primary aim to assess the clinical success rate of EUS-GBD as a first-line approach to the palliation of DMBO. METHODS: In all, 37 consecutive patients undergoing EUS-GBD with a new EC-LAMS were prospectively enrolled. Clinical success was defined as bilirubin level decrease >15% within 24 h and >50% within 14 days after EC-LAMS placement. RESULTS: The mean age was 73.5 ± 10.8 years; there were 17 male patients (45.9%). EC-LAMS placement was technically feasible in all patients (100%) and the clinical success rate was 100%. Four patients (10.8%) experienced adverse events, one bleeding, one food impaction, and two cystic duct obstructions because of disease progression. No stent-related deaths were observed. The mean hospitalization was 7.7 ± 3.4 days. Median overall survival was 4 months (95% confidence interval 1-8). CONCLUSION: Endoscopic ultrasound-guided gallbladder drainage with the new EC-LAMS is a valid option in palliative endoscopic biliary drainage as a first-step approach in low survival patients with malignant jaundice unfit for surgery. A smaller diameter EC-LAMS should be preferred, particularly if the drainage is performed through the stomach, to avoid potential food impaction, which could result in stent dysfunction.

Comparative diagnostic performance of different techniques for EUS-guided fine-needle biopsy sampling of solid pancreatic masses: a network meta-analysis.

BACKGROUND AND AIMS: Evidence is limited on the comparative diagnostic performance of tissue sampling techniques for EUS-guided fine-needle biopsy sampling of pancreatic masses. We performed a systematic review with network meta-analysis to compare these techniques. METHODS: Rates of sample adequacy, blood contamination, and tissue integrity using fine-needle biopsy sampling needles were evaluated. Direct and indirect comparisons were performed among the slow-pull, dry-suction, modified wet-suction, or no-suction techniques. Results are expressed as risk ratio (RR) and 95% confidence interval (CI). RESULTS: Overall, 9 randomized controlled trials (756 patients) were identified. On network meta-analysis, the no-suction technique was significantly inferior to the other techniques (RR, .85 [95% CI, .78-.92] vs slow pull; RR, .85 [95% CI, .78-.92] vs dry suction; RR, .83 [95% CI, .76-.90] vs modified wet suction) in terms of sample adequacy. Consequently, modified wet suction was shown to be the best technique (surface under the cumulative ranking curve score, .90), with the no-suction technique showing poorer performance in terms of sample adequacy (surface under the cumulative ranking curve score, .14). Dry suction was associated with significantly higher rates of blood contamination as compared with the slow-pull technique (RR, 1.44; 95% CI, 1.15-1.80), whereas no suction led to less blood contamination of samples in comparison with other techniques (RR, .71 [95% CI, .52-.97] vs slow pull; RR, .49 [95% CI, .36-.66] vs dry suction; RR, .57 [95% CI, .40-.81] vs modified wet suction). The modified wet-suction technique significantly outperformed dry suction in terms of tissue integrity of the sample (RR, 1.36; 95% CI, 1.06-1.75). CONCLUSIONS: Modified wet suction seemed to provide high rates of integrity and adequate samples, albeit with high blood contamination. The no-suction technique performed significantly worse than other sampling strategies.

Diagnostic accuracy and safety of EUS-guided end-cutting fine-needle biopsy needles for tissue sampling of abdominal and mediastinal lymphadenopathies: a prospective multicenter series.

BACKGROUND AND AIMS: The role of the newer EUS fine-needle biopsy needles in lymphadenopathies (LAs) is still under evaluation. We aimed to evaluate the diagnostic accuracy and adverse event rate of EUS-guided fine-needle biopsy sampling (EUS-FNB) in diagnosing LAs. METHODS: From June 2015 to June 2022, all patients referred to 4 institutions for EUS-FNB of mediastinal and abdominal LAs were enrolled. Twenty-two-gauge Franseen tip or 25-gauge fork-tip needles were used. The criterion standard for positive results was surgery or imaging and clinical evolution over a follow-up of at least 1 year. RESULTS: One hundred consecutive patients were enrolled, consisting of those with a new diagnosis of LA (40%), presence of LA with a previous history of neoplasia (51%), or suspected lymphoproliferative disease (9%). EUS-FNB was technically feasible in all LA patients with 2 to 3 passes (mean, 2.62 ± .93). The overall sensitivity, positive predictive value, specificity, negative predictive value, and accuracy for EUS-FNB were 96.20%, 100%, 100%, 87.50%, and 97.00%, respectively. Histologic analysis was feasible in 89% of cases. Cytologic evaluation was performed in 67% of specimens. A statistical difference between the accuracy of the 22-gauge or 25-gauge needle (P = .63) was not found. A subanalysis on lymphoproliferative disease revealed a sensitivity and accuracy of 89.29% and 90.0%, respectively. No adverse events were recorded. CONCLUSIONS: EUS-FNB with new end-cutting needles is a valuable and safe method to diagnose LAs. The high quality of histologic cores and the good amount of tissue allowed a complete immunohistochemical analysis of metastatic LAs and precise subtyping of the lymphomas. (Clinical trial registration number: NCT02855151.).

EUS-guided gallbladder drainage using a lumen-apposing metal stent as rescue treatment for malignant distal biliary obstruction: a large multicenter experience.

BACKGROUND AND AIMS: EUS-guided gallbladder drainage (EUS-GBD) with lumen-apposing metal stents (LAMSs) has been reported as a rescue treatment with encouraging results for the relief of jaundice in patients with distal malignant biliary obstruction (DMBO) and after failure of both ERCP and EUS-guided choledochoduodenostomy. METHODS: This was a multicenter retrospective analysis of all cases of consecutive EUS-GBD with LAMSs used as a rescue treatment for patients with DMBO in 14 Italian centers from June 2015 to June 2020. Primary endpoints were technical and clinical success, whereas the secondary endpoint was the adverse event (AE) rate. RESULTS: Forty-eight patients (52.1% women) with a mean age of 74.3 ± 11.7 years were included in the study. Biliary stricture was related to pancreatic adenocarcinoma (85.4%), duodenal adenocarcinoma (2.1%), cholangiocarcinoma (4.2%), ampullary cancer (2.1%), colon cancer (4.2%), and metastatic breast cancer (2.1%). The mean diameter of the common bile duct was 13.3 ± 2.8 mm. LAMSs were placed transgastrically in 58.3% of cases and transduodenally in 41.7%. Technical success was 100%, whereas clinical success was 81.3%, with a mean total bilirubin reduction after 2 weeks of 66.5%. The mean procedure time was 26.4 minutes, and the mean hospital stay was 9.2 ± 8.2 days. AEs occurred in 5 patients (10.4%): 3 were classified as intraprocedural and 2 were classified as delayed because they occurred after >15 days. When the American Society for Gastrointestinal Endoscopy lexicon was used, 2 AEs were mild and 3 were moderate (2 buried LAMSs). The mean follow-up was 122 days. CONCLUSIONS: Our study shows that EUS-GBD with LAMSs used as a rescue treatment for patients affected by DMBO represents a valuable option in terms of technical and clinical success rates, with an acceptable AE rate. To the best of our knowledge, this is the largest study concerning the use of this procedure. (Clinical trial registration number: NCT03903523.).

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.

Endoscopic ultrasound-guided fine-needle biopsy with or without macroscopic on-site evaluation: a randomized controlled noninferiority trial.

BACKGROUND : The advantage of using the macroscopic on-site evaluation (MOSE) technique during endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) performed with 22G Franseen needles has not been investigated. We aimed to compare EUS-FNB with MOSE vs. EUS-FNB performed with three needle passes. METHODS : This randomized trial involved 10 Italian referral centers. Consecutive patients referred for EUS-FNB of pancreatic or nonpancreatic solid lesions were included in the study and randomized to the two groups. MOSE was performed by gross visualization of the collected material by the endoscopists and considered adequate when a white/yellowish aggregate core longer than 10 mm was retrieved. The primary outcome was diagnostic accuracy. Secondary outcomes were specimen adequacy, number of needle passes, and safety. RESULTS : 370 patients with 234 pancreatic lesions (63.2 %) and 136 nonpancreatic lesions (36.8 %) were randomized (190 EUS-FNB with MOSE and 180 with standard EUS-FNB). No statistically significant differences were found between EUS-FNB with MOSE and conventional EUS-FNB in terms of diagnostic accuracy (90.0 % [95 %CI 84.8 %-93.9 %] vs. 87.8 % [95 %CI 82.1 %-92.2 %]; P = 0.49), sample adequacy (93.1 % [95 %CI 88.6 %-96.3 %] vs. 95.5 % [95 %CI 91.4 %-98 %]; P = 0.31), and rate of adverse events (2.6 % vs. 1.1 %; P = 0.28). The median number of passes was significantly lower in the EUS-FNB with MOSE group (1 vs. 3; P < 0.001). CONCLUSIONS : The accuracy of EUS-FNB with MOSE is noninferior to that of EUS-FNB with three needle passes. MOSE reliably assesses sample adequacy and reduces the number of needle passes required to obtain the diagnosis with a 22G Franseen needle.

EUS-guided coil and glue injection versus endoscopic glue injection for gastric varices: International multicentre propensity-matched analysis.

BACKGROUND: Gastric varices (GVs) are conventionally managed with endoscopic cyanoacrylate (E-CYA) glue injection. Endoscopic ultrasound (EUS)-guided therapy using combination of coils and CYA glue (EUS-CG) is a relatively recent modality. There is limited data comparing the two techniques. METHODOLOGY: This international multicentre study included patients with GV undergoing endotherapy from two Indian and two Italian tertiary care centres. Patients undergoing EUS-CG were compared with propensity-matched E-CYA cases from a cohort of 218 patients. Procedural details such as amount of glue, number of coils used, number of sessions required for obliteration, bleeding after index procedure rates and need for re-intervention were noted. RESULTS: Of 276 patients, 58 (male 42, 72.4%; mean age-44.3 ± 12.1 years) underwent EUS-CG and were compared with 118 propensity-matched cases of E-CYA. In the EUS-CG arm, complete obliteration at 4 weeks was noted in 54 (93.1%) cases. Compared to the E-CYA cohort, EUS-CG arm showed significantly lower number of session (1.0 vs. 1.5; p < 0.0001) requirement, lower subsequent-bleeding episodes (13.8% vs. 39.1%; p < 0.0001) and lower re-intervention (12.1% vs. 50.4%; p < 0.001) rates. On multivariable regression analysis, size of the varix (aOR-1.17; CI 1.08-1.26) and technique of therapy (aOR-14.71; CI 4.32-50.0) were significant predictors of re-bleeding. A maximum GV size >17.5 mm had a 69% predictive accuracy for need for re-intervention. CONCLUSION: Endoscopic ultrasound-guided therapy of GV using coil and CYA glue is a safe technique with better efficacy and lower re-bleeding rates on follow-up compared to the conventional endoscopic CYA therapy.

Endoscopic Ultrasound Gastro-Enteroanastomosis for Benign Gastric Outlet Obstruction due to Large Duodenal Diverticula.

Gastric outlet obstruction is a condition characterized by inadequate gastric emptying due to benign or malignant conditions inducing an inadequate oral intake. In recent years, a novel therapeutic treatment for this condition is given by the use of electrocautery lumen-apposing metal stents. In this case report, we want to present an example of a benign condition treated by endoscopic ultrasound-guided gastroenterostomy with the bi-flanged SpaxusTM stent (Taewoong Medical Co.) mounted on electrocautery catheter.

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.

Diagnostic accuracy of EUS-guided fine-needle biopsy sampling by macroscopic on-site evaluation: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Assessment of EUS-guided fine-needle tissue acquisition by macroscopic on-site evaluation (MOSE) is gathering attention. Studies report good diagnostic parameters with MOSE; however, the overall data are limited. We conducted this systematic review and meta-analysis to report on the pooled diagnostic assessment parameters of EUS-guided tissue acquisition by MOSE using fine-needle biopsy sampling (FNB). METHODS: Multiple databases were searched (from inception to December 2021), and studies that reported on the diagnostic assessment of EUS-guided tissue acquisition by MOSE were selected. Pooled diagnostic accuracy, sensitivity, specificity, and positive and negative predictive values were calculated by standard meta-analysis methods following the random-effects model. Heterogeneity was assessed by I2 statistics. RESULTS: Fourteen studies were included in the analysis, and 1508 lesions were biopsy sampled in 1489 patients undergoing EUS-guided tissue acquisition. MOSE definition included a visible core of tissue with opacity and "wormlike" features of adequate size and length (≥4 mm). The pooled accuracy of FNA and/or FNB specimens in yielding a pathologic diagnosis by MOSE was 91.3% (95% confidence interval [CI], 88.6-93.3; I2 = 66%), pooled sensitivity was 91.5% (95% CI, 88.6-93.6; I2 = 66%), pooled specificity was 98.9% (95% CI, 96.6-99.7; I2 = 80%), pooled positive predictive value was 98.8% (95% CI, 97.4-99.5; I2 = 33%), and pooled negative predictive value was 55.5% (95% CI, 46.9-63.9; I2 = 95%). Subgroup analyses by newer-generation FNB needles demonstrated similar pooled rates, with minimal adverse events (2.5%; 95% CI, 1.5-3.9; I2 = 21%). CONCLUSIONS: Excellent pooled diagnostic accuracy parameters were demonstrated in EUS-guided tissue acquisition by FNB using the MOSE method.

Safety and efficacy of a novel electrocautery-enhanced lumen-apposing metal stent in interventional EUS procedures (with video).

BACKGROUND AND AIMS: Electrocautery-tip lumen-apposing metal stents (EC-LAMSs) have extended the indications of therapeutic EUS. We aimed to retrospectively evaluate safety and technical and clinical success of a newly developed EC-LAMS, the Hot-Spaxus (Taewoong Medical Co, Gimpo, Korea), for various EUS-guided procedures. METHODS: We included and retrospectively analyzed consecutive patients at 8 tertiary care referral centers who had undergone EUS interventional procedures using the Hot-Spaxus between October 2018 and February 2021. RESULTS: Of 58 included patients (male-to-female, 36:22; mean age, 63.5 ± 14.9 years), 29 had undergone pancreatic fluid collection drainage (50%), 22 (37.9%) biliary drainage for malignant distal obstruction, 3 (5.1%) gallbladder drainage for acute cholecystitis, 3 gastroenteroanastomoses, and 1 (1.7%) pelvic collection drainage. Technical success was achieved in 54 of 58 patients (93.1%) and clinical success in all 58. Adverse events occurred in 6 patients (11.1%): 2 early (3.7%), 1 late (1.8%), and 3 long term (5.6%). The outcomes were similar to those observed in a control group of patients treated with the Hot-Axios (Boston Scientific, Marlborough, Mass, USA), the other available EC-LAMS. CONCLUSIONS: Our study showed that the novel EC-LAMS has high technical and clinical success rates for various interventional EUS indications. Future multicenter prospective studies will better clarify the role of this new EC-LAMS for different indications.

A Novel Lumen-Apposing Metal Stent with an Electrocautery Tip for Different Indications: Initial Experience in a Referral Center.

BACKGROUND AND STUDY AIMS: Recently, a new electrocautery lumen-apposing metal stent (EC-LAMS) has been launched. The primary aim of our study was to assess the feasibility of the freehand placement with intra-channel release of the new EC-LAMS. The secondary aims were to assess technical and clinical outcomes and rates of adverse events. PATIENTS AND METHODS: We retrospectively evaluated 5 patients (3 F; mean age: 75.6 ± 14.6 years) who underwent new EC-LAMS placement for different indications (cholecystitis, malignant biliary obstruction, and malignant gastric outlet obstruction). We described all the procedures of EC-LAMS placement, providing also a video of one of them (see online suppl. material; for all online suppl. material, see www.karger.com/doi/10.1159/000518539). RESULTS: Technical and clinical success was achieved in all patients who underwent new EC-LAMS placement, and no AEs were experienced. All of the EC-LAMS were placed using the freehand technique with intra-channel release. CONCLUSIONS: Our initial experience with the new EC-LAMS showed a good performance of this device for different indications, especially if the stents are placed freehand and with intra-channel release. Further studies are needed to confirm our preliminary data and first impression about this new EC-LAMS.

Through-the-scope esophageal stent for the relief of malignant dysphagia: Results of a multicentric study (with video).

BACKGROUND AND AIM: In presence of malignant dysphagia, in patients unfit for surgery, the placement of a self-expandable metal stent (SEMS) represents a safe and effective palliative treatment. Esophageal stents (ES) present an over-the-wire mechanism where the stent is deployed under X-ray control. Recently a through-the-scope (TTS) ES was launched. The aim of our retrospective study is to assess the technical and clinical success of the new TTS-ES. MATERIALS AND METHODS: Patients with malignant dysphagia caused by esophageal cancer or ab-extrinsic compression, who underwent TTS esophageal stent in six Italian endoscopic referral centers, were retrospectively reviewed. RESULTS: A total of 40 patients were enrolled. TTS stent placement was successful in 39/40 patients (97.5%). 31 patients had an Ogilvie score of 4, nine an Ogilvie 3. After 2 weeks from stent placement 29 reported Ogilvie score of 0, eight a score of 1. None of the patients developed retrosternal pain requiring drugs. No patient experienced perforation, bleeding or migration. A total of seven patients (18%) developed dysphagia as late adverse event (AE). CONCLUSION: Through-the-scope ES presented less AEs, in terms of bleeding and perforation, if compared to the previous published data. An anti-migration system could be helpful, especially when the stent is placed for "ab-extrinseco" malignant dysphagia.

New biliary and pancreatic biodegradable stent placement: a single-center, prospective, pilot study (with video).

BACKGROUND AND AIMS: In recent years, the feasibility and safety of endoscopic placement of different biodegradable biliary stents have been investigated. New, helicoidally shaped, biliary and pancreatic biodegradable stents have been developed for endoscopic use. Stents are provided in different sizes and with 3 expected speeds of degradation: slow (11 weeks), medium (20 days), and fast (12 days). The aim of this study was to evaluate degradation time, technical outcomes, and safety of these stents. METHODS: This was a single-center, prospective, pilot study (August 2018 to January 2019) of consecutive patients with indication for biliary or pancreatic plastic stent positioning during ERCP. The primary outcome was the evaluation of degradation time of the stents, which was controlled by abdominal radiograph. Secondary outcomes were the evaluation of specific stent-related technical features (loadability, pushability, and fluoroscopic visibility) as compared with commonly used plastic stents and adverse events (AEs). RESULTS: Thirty-eight patients (11 women [28.9%]; median age, 68.05 ± 10.74 years) who received 53 biodegradable stents (34 [64.2%] biliary and 19 [35.8%] pancreatic stents) were enrolled in the study. Thirty-five (66%) slow-degrading stents, 6 (11.3%) medium-degrading stents, and 12 (22.6%) fast-degrading stents were used. At time 1, partial degradation of the stents was present in 48 cases (90.6%). Five stents (9.4%) prematurely migrated. At the subsequent time 2 evaluation, complete degradation occurred in 100% of cases. Stent loadability was defined as excellent in all cases. Pushability of the stent was scored as excellent in 48 cases (90.5%), good in 4 cases (7.5%), and fair in 1 case (1.9%). Fluoroscopic visualization was excellent in 11 cases (20.8%), good in 39 cases (73.6%), and fair in 3 (5.6%). Only 1 AE of mild post-ERCP pancreatitis occurred. CONCLUSIONS: The results of our study suggest that the biodegradation of the new biliary and pancreatic stents is reliable and in line with expected times and technically successful in a variety of indications. Further randomized multicenter studies are required to validate our preliminary findings. (Clinical trial registration number: NCT03767166.).