Endoscopic submucosal dissection: Italian national survey on current practices, training and outcomes.

BACKGROUND AND AIMS: Most of the evidence supporting endoscopic submucosal dissection (ESD) comes from Asia. European data are primarily reported by specialized referral centers and thus may not be representative of common European ESD practice. The aim of this study is to understand the current state of ESD practice across Italian endoscopy centers. METHODS: All Italian endoscopists who were known to perform ESD were invited to complete a structured questionnaire including: operator features and competencies, ESD training details and clinical outcomes over a 2-year period. RESULTS: Twenty-nine operators from 23 centers (69% response rate) completed the questionnaire: 18 (62%) were <50 years old; 7 (24%) were female; 16 (70%) were located in Northern Italy. Overall ESD volume was <40 cases in 9 (31%) operators, 40-80 in 8 (27.5%), 80-150 in 4 (13.8%) and >150 in 8 (27.5%). Colorectal ESD was predominant for operators with an experience >80 cases. En-bloc resection rates ranged from 77.2 to 97.2% depending on the anatomic location with an R0 resection rate range of 75.3-93.6%. ESD perforation rates in the colon and rectum were significantly lower when experience was >150 compared to 80-150 cases (p < 0.0001 and p = 0.006 for colon and rectum, respectively). CONCLUSION: ESD in Italy is performed by a significant number of operators. Overall, Italian endoscopists performing ESD have achieved a good competence level. However, there is much variability in training protocols, initial supervision of procedures, practice settings, case mix and procedural volume/year that are likely responsible for some of the suboptimal resectional outcomes and increased perforation risk, mainly in the colon. Standardized training programs, practice parameters and auditing of outcomes are required.

The Clinical Value of Fluorescent Lymphography with Indocyanine Green During Robotic Surgery for Gastric Cancer: a Matched Cohort Study.

BACKGROUND: Near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) has been recently introduced for lymphatic mapping in several tumors. We aimed at investigating whether this technology may improve the intraoperative visualization of lymph nodes during robotic gastrectomy for gastric cancer. METHODS: Between June 2014 and June 2018, a total of 94 patients underwent robotic gastrectomy with D2 lymph node dissection for gastric cancer. In 37 patients, ICG was injected endoscopically into the submucosal layer around the tumor the day before surgery. After propensity score matching, the results of these 37 patients were compared with the results of 37 control patients who had undergone robotic gastrectomy without ICG injection. RESULTS: Among the 37 patients within the ICG group, no adverse events related to ICG injection or intraoperative NIR imaging occurred. After completion of D2 lymph node dissection, no residual fluorescent lymph nodes were left in the surgical field. A mean of 19.4 ± 14.7 fluorescent lymph nodes was identified per patient. The mean total number of harvested lymph nodes was significantly higher in the ICG group than in the control group (50.8 vs 40.1, P = 0.03). In the ICG group, 23 patients had metastatic lymph nodes. The accuracy, sensitivity, and specificity of ICG fluorescence for metastatic lymph nodes were 62.2%, 52.6%, and 63.0%, respectively. CONCLUSION: Our study indicates that NIR imaging with ICG may provide additional node detection during robotic surgery for gastric cancer. Unfortunately, this technique failed to show good selectivity for metastatic lymph nodes.

Intra-procedural and delayed bleeding after resection of large colorectal lesions: The SCALP study.

Background and aim: The safety of endoscopic resection of large colorectal lesions (LCLs) (≥20 mm) is clinically relevant. The aim of the present study was to assess the rate of post-resection adverse events (AEs) in a real-life setting. Patients and methods: In a prospective, multicentre, observational study, data from consecutive resections of LCLs over a 6-month period were collected in 24 centres. Patients were followed up at 15 days from resection for AEs. The primary endpoint was intra-procedural bleeding according to lesion morphology. Secondary endpoints were delayed bleeding and perforation. Patient and polyp characteristics, and polypectomy techniques were analysed with respect to the bleeding events. Results: In total, 1504 patients (female/male: 633/871, mean age, 66.1) with 1648 LCLs (29.1% pedunculated and 70.9% non-pedunculated lesions) were included. Overall, 168 (11.2%) patients had post-resection bleeding (8.5 and 2.0% immediate and delayed, respectively), while 15 (1.0%) cases of perforation occurred. Independent predictors of immediate bleeding for pedunculated lesions were bleeding prophylaxis (odds ratio (OR) 0.28, 95% confidence interval (CI) 0.13-0.62), simple polypectomy (versus endoscopic mucosal resection, OR 0.38, 95% CI 0.17-0.88) and inpatient setting (OR 2.21, 95% CI 1.07-5.08), while bleeding prophylaxis (OR 0.37, 95% CI 0.30-0.98), academic setting (OR 0.27, 95% CI 0.12-0.54) and size (OR 1.03, 95% CI 1.00-1.05) were predictors for those non-pedunculated. Indication for colonoscopy (screening versus diagnostic (OR 0.33, 95% CI 0.12-0.86)), antithrombotic therapy (OR 3.12, 95% CI 1.54-6.39) and size (OR 2.34, 95% CI 1.12-4.87) independently predicted delayed bleeding. Conclusions: A low rate of post-resection AEs was observed in a real-life setting, reassuring as to the safety of endoscopic resection of ≥2 cm colorectal lesions. Bleeding prophylaxis reduced the intra-procedural bleeding risk, while antithrombotic therapy increased delayed bleeding.CLINICALTRIAL: (NCT02694120).

IMPlementing split Regimen OVEr Single dose using a Plan-Do-Study-Act approach (IMPROVES study).

Background and aims A split-dose regimen for colonoscopy is recommended by international guidelines, but its adoption is still suboptimal. Our aim was to assess whether a Plan-Do-Study-Act approach (PDSA), a scientific method promoting quality improvement, would be able to improve adherence to a split-dose regimen, and to identify factors influencing its adoption. Methods This study consisted of three phases: Cycle 1: a cross-sectional assessment of split-dose adherence in consecutive outpatients/inpatients undergoing colonoscopies in 74 Italian centers; Educational intervention: regional meetings with literature review, analysis of Cycle 1 data, and discussion on corrective measures; local diffusion of educational material and tools for improvement; Cycle 2: reassessment of split-dose adherence after spontaneous local interventions. Demographic, clinical, and procedural variables were systematically collected. Multivariate logistic regression was used to identify predictors of split-dose adoption. Results In total, 8213 patients (mean age = 60.29 years (SD = 13.58), men = 54 %, outpatients = 88.4 %) were enrolled between 2013 and 2016 (Cycle 1 = 4189 patients and Cycle 2 = 4024 patients). Split-dose adoption rose from 29.1 % in Cycle 1 to 51.1 % in Cycle 2 ( P  < 0.0001), and being enrolled in Cycle 2 independently predicted split-dose adherence (OR = 2.9; 95 %CI 2.6 - 3.3). The adoption improved in all time slots, including colonoscopies scheduled before 0930. The main corrective measures were: rescheduling of colonoscopies after 0930 (between 0930 and 1130: OR = 2.6; 95 %CI 2.3 - 3.1; after 1130: OR = 7; 95 %CI 5.9 - 8.4); the cleansing regimen communicated by the Endoscopy unit (via form: OR = 1.6; 95 %CI 1.3 - 1.9; via visit: OR = 2.1; 95 %CI 1.7 - 2.5); a decrease in the use of deep sedation (OR = 2; 95 %CI 1.7 - 2.5). Conclusions An educational intervention with observation-driven corrections through a PDSA approach was able to substantially increase the adoption of a split-dose regimen.

Periendoscopic management of direct oral anticoagulants: a prospective cohort study.

OBJECTIVE: To assess the frequency of adverse events associated with periendoscopic management of direct oral anticoagulants (DOACs) in patients undergoing elective GI endoscopy and the efficacy and safety of the British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) recommendations (NCT02734316). DESIGN: Consecutive patients on DOACs scheduled for elective GI endoscopy were prospectively included. The timing of DOAC interruption and resumption before and after the procedures were recorded, along with clinical and procedural data. Procedures were stratified into low-risk and high-risk for GI-related bleeding, and patients into low-risk and high-risk for thromboembolic events. Patients were followed-up for 30 days for major and clinically relevant non-major bleeding events (CRNMB), arterial and venous thromboembolism and death. RESULTS: Of 529 patients, 38% and 62% underwent high-risk and low-risk procedures, respectively. There were 45 (8.5%; 95% CI 6.3% to 11.2%) major or CRNMB events and 2 (0.4%; 95% CI 0% to 1.4%) thromboembolic events (transient ischaemic attacks). Overall, the incidence of bleeding events was 1.8% (95% CI 0.7% to 4%) and 19.3% (95% CI 14.1% to 25.4%) in low-risk and high-risk procedures, respectively. For high-risk procedures, the incidence of intraprocedural bleeding was similar in patients who interrupted anticoagulation according to BSG/ESGE guidelines or earlier (10.3%vs10.8%, p=0.99), with a trend for a lower risk as compared with those who stopped anticoagulation later (10.3%vs25%, p=0.07). The incidence of delayed bleeding appeared similar in patients who resumed anticoagulation according to BSG/ESGE guidelines or later (6.6%vs7.7%, p=0.76), but it tended to increase when DOAC was resumed earlier (14.4%vs6.6%, p=0.27). The risk of delayed major bleeding was significantly higher in patients receiving heparin bridging than in non-bridged ones (26.6%vs5.9%, p=0.017). CONCLUSION: High-risk procedures in patients on DOACs are associated with a substantial risk of bleeding, further increased by heparin bridging. Adoption of the BSG/ESGE guidelines in periendoscopic management of DOACs seems to result in a favourable benefit/risk ratio. TRIAL REGISTRATION NUMBER: NCT02734316; Pre-results.

Taeniasis: A possible cause of ileal bleeding.

Taenia spp. are flatworms of the class Cestoda, whose definitive hosts are humans and primates. Human infestation (taeniasis) results from the ingestion of raw meat contaminated with encysted larval tapeworms and is considered relatively harmless and mostly asymptomatic. Anemia is not recognized as a possible sign of taeniasis and taeniasis-induced hemorrhage is not described in medical books. Its therapy is based on anthelmintics such praziquantel, niclosamide or albendazole. Here we describe a case of acute ileal bleeding in an Italian man affected with both Taenia spp. infestation resistant to albendazole and Helicobacter pylori-associated duodenal ulcers.

Synergistic inhibitory effect of cyclosporin A and vitamin D derivatives on T-lymphocyte proliferation in active ulcerative colitis.

OBJECTIVE: 1,25-Dihydroxyvitamin D3 [1,25(OH)2D3], the hormonal active form of vitamin D3, could represent a potentially therapeutic agent in autoimmune diseases. Cyclosporin A (CsA) shows immunoregulatory properties, which, in many respects, seem to be similar to those of 1,25(OH)2D3. Our aim was to investigate the possible synergistic effect exerted by CsA in combination with 1,25(OH)2D3 or its nonhypercalcemic analogues, EB 1089 and KH 1060, on the proliferative response of T lymphocytes obtained from active ulcerative colitis patients. METHODS: The T lymphocyte-enriched population was treated with phytohemagglutinin and CsA (doses from 1 ng to 1000 ng/ml) alone or in association with 1,25(OH)2D3 or EB 1089 or KH 1060 (0.1, 1, 10 nM final concentration). Cell proliferation was determined by [3H]thymidine incorporation and analyzed on day 5 of culture. RESULTS: After incubation with CsA, T lymphocyte proliferation was significantly inhibited in comparison with the vehicle-treated cultures. However, T lymphocytes from ulcerative colitis patients were significantly more sensitive to CsA than those from healthy controls. The inhibition in T lymphocyte proliferation, after treatment of the cultures with CsA associated with either 1,25(OH)2D3 or EB 1089 or KH 1060, was synergistic at well-defined concentrations. CONCLUSIONS: Taking into account the lowest CsA dose (1 ng/ml), the highest synergistic inhibition in the proliferation of T lymphocytes prepared from ulcerative colitis patients was found combining CsA and 10 nM of 1,25(OH)2D3 or 10 nM of EB 1089 or KH 1060 at the three concentrations. The results obtained, associating the lowest CsA dose and the lowest KH 1060 concentration, may suggest an alternative therapeutic approach in these patients, reducing the dose, and consequently the toxicity, of CsA.