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.

Outcomes of a 3-Year Prospective Surveillance in Individuals at High Risk of Pancreatic Cancer.

INTRODUCTION: Pancreatic cancer (PC) surveillance of high-risk individuals (HRI) is becoming more common worldwide, aiming at anticipating PC diagnosis at a preclinical stage. In 2015, the Italian Registry of Families at Risk of Pancreatic Cancer was created. We aimed to assess the prevalence and incidence of pancreatic findings, oncological outcomes, and harms 7 years after the Italian Registry of Families at Risk of Pancreatic Cancer inception, focusing on individuals with at least a 3-year follow-up or developing events before. METHODS: HRI (subjects with a family history or mutation carriers with/without a family history were enrolled in 18 centers). They underwent annual magnetic resonance with cholangiopancreatography or endoscopic ultrasound (NCT04095195). RESULTS: During the study period (June 2015-September 2022), 679 individuals were enrolled. Of these, 524 (77.2%) underwent at least baseline imaging, and 156 (29.8%) with at least a 3-year follow-up or pancreatic malignancy/premalignancy-related events, and represented the study population. The median age was 51 (interquartile range 16) years. Familial PC cases accounted for 81.4% of HRI and individuals with pathogenic variant for 18.6%. Malignant (n = 8) and premalignant (1 PanIN3) lesions were found in 9 individuals. Five of these 8 cases occurred in pathogenic variant carriers, 4 in familial PC cases (2 tested negative at germline testing and 2 others were not tested). Three of the 8 PC were stage I. Five of the 8 PC were resectable, 3 Stage I, all advanced cases being prevalent. The 1-, 2-, and 3-year cumulative hazard of PC was 1.7%, 2.5%, and 3%, respectively. Median overall and disease-free survival of patients with resected PC were 18 and 12 months (95% CI not computable). Considering HRI who underwent baseline imaging, 6 pancreatic neuroendocrine neoplasms (1 resected) and 1 low-yield surgery (low-grade mixed-intraductal papillary mucinous neoplasm) were also reported. DISCUSSION: PC surveillance in a fully public health care system is feasible and safe, and leads to early PC or premalignant lesions diagnoses, mostly at baseline but also over time.

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.

Technical failure during colorectal endoscopic full-thickness resection: the "through thick and thin" study.

BACKGROUND: Endoscopic full-thickness resection (EFTR) is an effective and safe technique for nonlifting colorectal lesions. Technical issues or failures with the full-thickness resection device (FTRD) system are reported, but there are no detailed data. The aim of our study was to quantify and classify FTRD technical failures. METHODS: We performed a retrospective study involving 17 Italian centers with experience in advanced resection techniques and the required devices. Each center shared and classified all prospectively collected consecutive failures during colorectal EFTR using the FTRD from 2018 to 2022. The primary outcome was the technical failure rate and their classification; secondary outcomes included subsequent management, clinical success, and complications. RESULTS: Included lesions were mainly recurrent (52 %), with a mean (SD) dimension of 18.4 (7.5) mm. Among 750 EFTRs, failures occurred in 77 patients (35 women; mean [SD] age 69.4 [8.9] years). A classification was proposed: type I, snare noncutting (53 %); type II, clip misdeployment (31 %); and type III, cap misplacement (16 %). Among endoscopic treatments completed, rescue endoscopic mucosal resection was performed in 57 patients (74 %), allowing en bloc and R0 resection in 71 % and 64 %, respectively. The overall adverse event rate was 27.3 %. Pooled estimates for the rates of failure, complications, and rescue endoscopic therapy were similar for low and high volume centers (P = 0.08, P = 0.70, and P = 0.71, respectively). CONCLUSIONS: Colorectal EFTR with the FTRD is a challenging technique with a non-negligible rate of technical failure and complications. Experience in rescue resection techniques and multidisciplinary management are mandatory in this setting.

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.

Endoscopic full-thickness resection versus endoscopic submucosal dissection for challenging colorectal lesions: a randomized trial.

BACKGROUND AND AIMS: The optimal endoscopic resection method of challenging colorectal lesions (ie, adenomatous recurrences, nongranular laterally spreading tumors [LST-NGs], lesions without lifting sign <30 mm) is still under debate. The aim of this study was to directly compare endoscopic submucosal dissection (ESD) and endoscopic full-thickness resection (EFTR) for the resection of challenging colorectal lesions in a randomized trial. METHODS: A multicenter, prospective, randomized study was performed in 4 Italian referral centers. Consecutive patients referred for endoscopic resection of challenging lesions were randomly assigned to undergo EFTR or ESD. Primary outcomes were complete (R0) resection and en bloc resection of lesions. Technical success, procedure time, procedure speed, area of the resected specimen, adverse event rate, and local recurrence rate at 6 months were also compared. RESULTS: Overall, 90 patients were included in the study, equally representing the 3 challenging lesion types. Age and sex were comparable in the 2 groups. En bloc resection was obtained in 95.5% of the EFTR group and in 93.3% of the ESD group. R0 resection rate was comparable in the 2 groups (EFTR vs ESD, 42 [93.3%] vs 36 [80%]; P = .06). The EFTR group exhibited a significantly shorter total procedure time (25.6 ± 10.6 minutes vs 76.7 ± 26.4 minutes, P ≤ .01), as well as overall procedure speed (16.8 ± 11.8 mm2/min vs 11.9 ± 9.2 mm2/min, P = .03). The EFTR group had a significantly smaller mean lesion size (21.6 ± 8.3 mm vs 28.7 ± 7.7 mm, P ≤ .01). Adverse events were reported less frequently in patients in the EFTR group (4.44% vs 15.5%, P = .04). CONCLUSIONS: EFTR is comparable to ESD in the treatment of challenging colorectal lesions in terms of safety and efficacy. EFTR is considerably faster than ESD in the treatment of nonlifting lesions and adenoma recurrences. (Clinical trial registration number: NCT05502276.).

Artificial intelligence-assisted optical diagnosis for the resect-and-discard strategy in clinical practice: the Artificial intelligence BLI Characterization (ABC) study.

BACKGROUND: Optical diagnosis of colonic polyps is poorly reproducible outside of high volume referral centers. The present study aimed to assess whether real-time artificial intelligence (AI)-assisted optical diagnosis is accurate enough to implement the leave-in-situ strategy for diminutive (≤ 5 mm) rectosigmoid polyps (DRSPs). METHODS: Consecutive colonoscopy outpatients with ≥ 1 DRSP were included. DRSPs were categorized as adenomas or nonadenomas by the endoscopists, who had differing expertise in optical diagnosis, with the assistance of a real-time AI system (CAD-EYE). The primary end point was ≥ 90 % negative predictive value (NPV) for adenomatous histology in high confidence AI-assisted optical diagnosis of DRSPs (Preservation and Incorporation of Valuable endoscopic Innovations [PIVI-1] threshold), with histopathology as the reference standard. The agreement between optical- and histology-based post-polypectomy surveillance intervals (≥ 90 %; PIVI-2 threshold) was also calculated according to European Society of Gastrointestinal Endoscopy (ESGE) and United States Multi-Society Task Force (USMSTF) guidelines. RESULTS: Overall 596 DRSPs were retrieved for histology in 389 patients; an AI-assisted high confidence optical diagnosis was made in 92.3 %. The NPV of AI-assisted optical diagnosis for DRSPs (PIVI-1) was 91.0 % (95 %CI 87.1 %-93.9 %). The PIVI-2 threshold was met with 97.4 % (95 %CI 95.7 %-98.9 %) and 92.6 % (95 %CI 90.0 %-95.2 %) of patients according to ESGE and USMSTF, respectively. AI-assisted optical diagnosis accuracy was significantly lower for nonexperts (82.3 %, 95 %CI 76.4 %-87.3 %) than for experts (91.9 %, 95 %CI 88.5 %-94.5 %); however, nonexperts quickly approached the performance levels of experts over time. CONCLUSION: AI-assisted optical diagnosis matches the required PIVI thresholds. This does not however offset the need for endoscopists' high level confidence and expertise. The AI system seems to be useful, especially for nonexperts.

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.

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.

Predictors of adverse events after endoscopic ultrasound-guided through-the-needle biopsy of pancreatic cysts: a recursive partitioning analysis.

BACKGROUND AND STUDY AIMS : Endoscopic ultrasound-guided through-the-needle biopsy (TTNB) of pancreatic cystic lesions (PCLs) is associated with a non-negligible risk for adverse events (AEs). We aimed to identify the hierarchic interaction among independent predictors for TTNB-related AEs and to generate a prognostic model using recursive partitioning analysis (RPA). PATIENTS AND METHODS : Multicenter retrospective analysis of 506 patients with PCLs who underwent TTNB. RPA of predictors for AEs was performed and the model was validated by means of bootstrap resampling. RESULTS : Mean cysts size was 36.7 mm. Most common diagnoses were intraductal papillary mucinous neoplasm (IPMN, 45 %), serous cystadenoma (18.8 %), and mucinous cystadenoma (12.8 %). Fifty-eight (11.5 %) AEs were observed. At multivariate analysis, age (odds ratio [OR] 1.32, 1.09-2.14; p = 0.05), number of TTNB passes (OR from 2.17, 1.32-4.34 to OR 3.16, 2.03-6.34 with the increase of the number of passes), complete aspiration of the cyst (OR 0.56, 0.31-0.95; p = 0.02), and diagnosis of IPMN (OR 4.16, 2.27-7.69; p < 0.001) were found to be independent predictors of AEs, as confirmed by logistic regression and random forest analyses. RPA identified three risk classes: high-risk (IPMN sampled with multiple microforceps passes, 28 % AEs rate), low-risk (1.4 % AE rate, including patients < 64 years with other-than-IPMN diagnosis sampled with ≤ 2 microforceps passes and with complete aspiration of the cyst) and middle-risk class (6.1 % AEs rate, including the remaining patients). CONCLUSION : TTNB should be selectively used in the evaluation of patients with IPMN. The present model could be applied during patient selection as to optimize the benefit/risk of TTNB.

Endoscopic full-thickness resection of polyps involving the appendiceal orifice: a multicenter international experience.

BACKGROUND: Endoscopic resection of lesions involving the appendiceal orifice remains a challenge. We aimed to report outcomes with the full-thickness resection device (FTRD) for the resection of appendiceal lesions and identify factors associated with the occurrence of appendicitis. METHODS: This was a retrospective study at 18 tertiary-care centers (USA 12, Canada 1, Europe 5) between November 2016 and August 2020. Consecutive patients who underwent resection of an appendiceal orifice lesion using the FTRD were included. The primary outcome was the rate of R0 resection in neoplastic lesions, defined as negative lateral and deep margins on post-resection histologic evaluation. Secondary outcomes included the rates of: technical success (en bloc resection), clinical success (technical success without need for further surgical intervention), post-resection appendicitis, and polyp recurrence. RESULTS: 66 patients (32 women; mean age 64) underwent resection of colonic lesions involving the appendiceal orifice (mean [standard deviation] size, 14.5 (6.2) mm), with 40 (61 %) being deep, extending into the appendiceal lumen. Technical success was achieved in 59/66 patients (89 %), of which, 56 were found to be neoplastic lesions on post-resection pathology. Clinical success was achieved in 53/66 (80 %). R0 resection was achieved in 52/56 (93 %). Of the 58 patients in whom EFTR was completed who had no prior history of appendectomy, appendicitis was reported in 10 (17 %), with six (60 %) requiring surgical appendectomy. Follow-up colonoscopy was completed in 41 patients, with evidence of recurrence in five (12 %). CONCLUSIONS: The FTRD is a promising non-surgical alternative for resecting appendiceal lesions, but appendicitis occurs in 1/6 cases.

Accuracy of visual on-site evaluation (Vose) In predicting the adequacy of Eus-guided fine needle biopsy: A single center prospective study.

OBJECTIVE: Endoscopic ultrasound is the standard procedure for the diagnosis of pancreatic lesions and new needles have been developed to improve tissue acquisition (FNB). Rapid onset evaluation (ROSE) decreases the number of needle passes but is not always available. We introduced an easy and rapid method of direct classification of EUS-FNB sample namely Visual on-site evaluation (VOSE). AIMS: To assess the accuracy of VOSE in predicting the histological adequacy of specimens. To evaluate the diagnostic power of FNB and the rate of core tissue obtained. METHODS: Prospective single center study on patients with pancreatic lesions that underwent EUS-FNB. VOSE parameters were presence of blood, macroscopic visible core (MVC), number, color and length of specimen. The association between VOSE tool and histological adequacy was assessed. Fisher's exact test and Student's t-test used to compare categorical and continuous variables. Logistic regression analysis was used to assess association between variables. RESULTS: 99 patients (58.6% male; mean age 68.4 ± 10) enrolled, including 102 lesions. Total number of passes was 358 with median number of 4 (range, 2-4). The 92.7% of samples were adequate and it was higher with the 22-G needle than with 25G (96.5% vs 89.2% p 0.01). VOSE "red-mixed specimen" was associated with a higher probability of histological adequacy (OR 2.39 95% CI 1.03-5.42 p = 0.04). CONCLUSIONS: The VOSE tool "red-mixed specimen" can be used to predict the histological adequacy and guide the number of needle passes. Overall, FNB provides a high rate of adequate and diagnostic specimen and high rate of core tissue especially with the 22G needle.

Role of fluorescence confocal microscopy for rapid evaluation of EUS fine-needle biopsy sampling in pancreatic solid lesions.

BACKGROUND AND AIMS: EUS fine-needle biopsy (EUS-FNB) sampling is the standard procedure for diagnosis of pancreatic lesions. Fluorescence confocal microscopy (FCM) allows imaging of tissues in the fresh state, requiring minimal preparation without damage or loss of tissue. Until now, no data exist on FCM in the field of microhistologic specimens. We aimed to assess the diagnostic performance of FCM in predicting histologic adequacy of EUS-FNB samples in pancreatic solid lesions and to assess the agreement between FCM evaluation and final histology. METHODS: In this single-center prospective study on consecutive patients with pancreatic lesions receiving EUS-FNB, the obtained samples have been evaluated at FCM and classified as "inadequate" or "adequate" (benign, suspicious, or malignant). The kappa test was used to quantify agreement. The diagnostic accuracy of FCM was assessed. A P < .05 was considered to be statistically significant. RESULTS: From April 2020 to September 2020, 81 patients were enrolled. In all cases FCM showed the macro image of the sample and created a digital image. Of the samples, 92.6% was defined as adequate at the FCM evaluation and confirmed at histopathology. Histologic diagnoses were 8% benign, 17.3% atypical/suspicious, and 74.7% malignant with satisfactory agreement with the FCM evaluation (Cohen's κ coefficient, .95; 95% confidence interval [CI], .89-1.01; P = .001). The sensitivity of the FCM evaluation was 100% (95% CI, 95%-100%), specificity 66.7% (95% CI, 22.3%-95.7%), accuracy 97% (95% CI, 90.7%-99.7%), positive predictive value 97% (95% CI, 91.8%-99%), and negative predictive value 100%. CONCLUSIONS: FCM represents a new technique successfully applicable to microhistologic specimens. It provides fast information about sample adequacy in small specimens with good agreement in the final histology.

Linked-color imaging versus white-light colonoscopy in an organized colorectal cancer screening program.

BACKGROUND AND AIMS: Linked-color imaging (LCI), a new image-enhancing technology emphasizing contrast in mucosal color, has been demonstrated to substantially reduce polyp miss rate as compared with standard white-light imaging (WLI) in tandem colonoscopy studies. Whether LCI increases adenoma detection rate (ADR) remains unclear. METHODS: Consecutive subjects undergoing screening colonoscopy after fecal immunochemical test (FIT) positivity were 1:1 randomized to undergo colonoscopy with LCI or WLI, both in high-definition systems. Insertion and withdrawal phases of each colonoscopy were carried out using the same assigned light. Experienced endoscopists from 7 Italian centers participated in the study. Randomization was stratified by gender, age, and screening round. The primary outcome measure was represented by ADR. RESULTS: Of 704 eligible subjects, 649 were included (48.9% men, mean age ± standard deviation, 60.8 ± 7.3 years) and randomized to LCI (n = 326) or WLI (n = 323) colonoscopy. The ADR was higher in the LCI group (51.8%) than in the WLI group (43.7%) (relative risk, 1.19; 95% confidence interval, 1.01-1.40). The proportions of patients with advanced adenomas and sessile serrated lesions were, respectively, 21.2% and 8.6% in the LCI arm and 18.9% and 5.9% in the WLI arm (not significant for both comparisons). At multivariate analysis, LCI was independently associated with ADR, along with male gender, increasing age, and adequate (Boston Bowel Preparation Scale score ≥6) bowel preparation. At per-polyp analysis, the mean ± standard deviation number of adenomas per colonoscopy was comparable in the LCI and WLI arms, whereas the corresponding figures for proximal adenomas was significantly higher in the LCI group (.72 ± 1.2 vs .55 ± 1.07, P = .05) CONCLUSIONS: In FIT-positive patients undergoing screening colonoscopy, the routine use of LCI significantly increased the ADR. (Clinical trial registration number: NCT03690297.).

Rectal neoplasia extending to the dentate line: clinical outcomes of endoscopic submucosal dissection.

BACKGROUND: The European Society of Gastrointestinal Endoscopy (ESGE) and the Japan Gastroenterological Endoscopy Society (JGES) give no specific recommendations on the best treatment for colorectal neoplasia involving the dental line (DLCN). OBJECTIVE: Aim of this study was to analyse efficacy and safety of Endoscopic Submucosal Dissection in the treatment of colorectal neoplasia involving the dentate line (DLCN) compared to non-DLCN. DESIGN: Retrospective study. PATIENTS: We retrospectively evaluated all consecutive patients undergoing ESD for rectal neoplasia at two endoscopical tertiary referral centers (Italy and Japan) from January 2008 to December 2019. MAIN OUTCOME MEASURES: Anthropometric, clinical, procedural, and follow-up data was collected, analysed, and compared between patients with DLCN and patients with non-DLCN. RESULTS: Overall, 314 patients were enrolled (163 female, 51.9%). Mean age was 68 years (range, 32-92 years). En-bloc resection was achieved in 311/314 (99%) patients. Lesion size was higher in DLCN group than in the non-DLCN group (46.1 vs 38.9 mm; p = .03). Submucosal invasion rate was also higher in the DLCN group (29.6 vs 18.4%, p = .04). Procedure time was significantly longer in the DLCN group, (89.6 vs. 73.1 min; p = .002). Hospitalization length following ESD was similar in both groups. LIMITATIONS: Retrospective study design. CONCLUSIONS: ESD seems to be safe and effective in the treatment of colorectal neoplasia involving the dentate line and can be considered the best therapeutic strategy.

Endoscopic full-thickness resection of duodenal lesions (with video).

BACKGROUND AND AIM: The endoscopic treatment of non-lifting or submucosal duodenal lesions is associated with a high risk of incomplete resection and adverse events. Clip-assisted endoscopic full-thickness resection (EFTR) is a new approach for en bloc removal of neoplastic lesions in the GI tract. The aim of this study was to investigate its efficacy and safety in the duodenum. MATERIALS AND METHODS: We retrospectively collected all consecutive patients with duodenal lesions who underwent EFTR with OTSC (Ovesco Endoscopy, Tübingen, Germany) or the new full-thickness resection device (FTRD; Ovesco Endoscopy, Tübingen, Germany). Complete resection rate was defined as histologically-verified R0 resection. Main endoscopic and clinical outcomes (technical success, rate of EFTR, adverse events) were systematically assessed at 3 and 6 months. RESULTS: Between May 2017 and January 2019, 10 patients with duodenal lesions underwent EFTR (5 non-lifting adenomas, 2 adenomas recurrence/relapse and 3 subepithelial tumours). Technical success was overall achieved in 8/10 cases (80%). The two FTRD failed cases were completed with snare resection. The complete full-thickness resection rate was achieved in 8/10 (80%), while in two cases it was limited to mucosal or submucosal layer. R0 resection rate was achieved in 8/10 (80%) patients. The mean procedure time was 75 min (range 53-120 min). There were no major adverse events. At 3 and 6-month follow-up, no recurrence was observed. CONCLUSIONS: Clip-assisted EFTR is a feasible and effective technique for en bloc resection of "difficult" superficial neoplasia and submucosal lesions in the duodenum, representing another technique that must be part of the endoscopist's armamentarium.

EUS-guided trans-esophageal drainage of a mediastinal necrotic fluid collection using the axios electrocautery enhanced delivery system™.

Mediastinal collection secondary to necrotic acute pancreatitis, is an extremely rare event caused by the posterior rupture of the pancreatic duct into the retroperitoneal space with the penetration of the pancreatic fluid through the diaphragmatic orifices. Infection of the necrotic collection may occur with a consequent substantial increase of the mortality rate. Due to the rarity of this severe condition, no consensus is known about the management of infected mediastinal necrotic collections. We reported the case of a 61-year-old male who was critically unwell secondary to a large mediastinal necrotic collections after necrotic acute pancreatitis with no improvement after surgery. The patient was successfully treated by EUS-guided trans-esophageal drainage using the AXIOS Electrocautery Enhanced Delivery System™. This procedure proved in this case to be a safe and effective option for the management of infected necrotic mediastinal collections.

Feasibility of EUS-guided Nd:YAG laser ablation of unresectable pancreatic adenocarcinoma.

BACKGROUND AND AIMS: EUS has become an interventional technique in which a needle may be used as a vehicle to deliver therapeutic agents. Laser ablation (LA) has been used to treat many primary and secondary neoplasms. This study aimed to assess the feasibility of EUS-guided LA for unresectable (UR) pancreatic cancer. METHODS: Patients with stage IIb-III pancreatic cancer underwent EUS-guided LA. All patients were unresponsive to previous chemoradiotherapy. LA was performed by using a 300-µm flexible fiber preloaded onto a 22-gauge fine needle. A 1064-nm wavelength neodymium-yttrium aluminum garnet (Nd:YAG) laser light with different power settings of 2 W for 800 J, 1000 J, and 1200 J; 3 W for 800 J, 1000 J, and 1200 J; and 4 W for 800 J, 1000 J, and 1200 J was used. Each patient was treated with a single application of 1 of these settings. The application time of the power settings ranged from 200 to 600 seconds. RESULTS: Nine patients (median age, 74.7; range 55-85) underwent Nd:Yag LA. The mean size of the focal lesion was 35.4 mm (range, 21-45). The ablation area, demonstrated by 24-hour CT, ranged from .4 cm3 (for the lower power setting of 2 W/800 J) to a maximum of 6.4 cm3 (for 4 W/1000 J). The procedure was completed in all 9 patients without adverse events. CONCLUSION: In our human experience, EUS-guided LA was feasible and well tolerated in patients with UR pancreatic cancer.

Temporary FC-SEMS for type II ERCP-related perforations: a case series from two referral centers and review of the literature.

BACKGROUND AND AIM: Some case reports have shown that fully covered self-expandable metal stents (FC-SEMS) are effective in cases of Stapfer Type II perforation as rescue treatment. The aim of the study was to assess the efficacy and safety of temporary placement of FC-SEMS as primary treatment for Type II perforations and review the literature regarding the use of FC-SEMS in this setting. PATIENTS AND METHOD: Retrospective analysis of consecutive patients with Type II perforation treated with immediate placement of FC-SEMS. Primary outcomes were need for surgery and mortality rate. Secondary outcomes were complications, technical and clinical success, time to post-operative feeding, length of the hospitalization and time to stent removal. RESULTS: Overall, 18 consecutive patients were enrolled (median age 71.5). All patients were treated with FC-SEMS (6-10 mm, 4-8 cm long). In all patients, there were no need for surgery, and no patient died. Technical and clinical success were achieved both in 100% of cases. The median time to stent removal was 43 (2-105) days. The median hospital stay was of 10 (4-21) days. Median time to post-operative feeding was 4 days (2-15). CONCLUSION: FC-SEMS placement could be a safe and effective treatment in Type II perforations and represent a valuable development and innovation of conservative treatment.

Laser ablation of the biliary tree: in vivo proof of concept as potential treatment of unresectable cholangiocarcinoma.

OBJECTIVES: The palliative treatment of cholangiocarcinoma is based on stent placement with well-known procedure-related complications. Consequently, alternative energy-based techniques were put forward with controversial long-term results. This study aims to evaluate the safety and effectiveness of biliary tree laser ablation (LA) in terms of: (i) absence of perforation, (ii) temperature increase, (iii) induced thermal damage in in vivo models. MATERIALS AND METHODS: The common bile duct and cystic ducts of two pigs were ablated with a diode laser (circumferential irradiation pattern) for 6 and 3 min at 7 W. Laser settings were chosen from previous ex vivo experiments. Local temperature was monitored through a fibre Bragg grating (FBG) sensor embedded into the laser delivery probe. Histopathological analysis of the ablated specimen was performed through in situ endomicroscopy, haematoxylin and eosin (H&E) and nicotinamide adenine dinucleotide (NADH) stains. RESULTS: Temperature reached a plateau of 53 °C with consequent thermal damage on the application area, regardless of laser settings and application sites. No perforation was detected macroscopically or microscopically. At the H&E stain, wall integrity was always preserved. The NADH stain allowed to evaluate damage extension. It turned out that the ablation spreading width depended on application time and duct diameter. In situ endomicroscopy revealed a clear distinction between ablated and non-ablated areas. CONCLUSIONS: The temperature distribution obtained through LA proved to induce a safe and effective intraductal coagulative necrosis of biliary ducts. These results represent the basis for further experiments on tumour-bearing models for the treatment of obstructive cholangiocarcinoma.