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BACKGROUND: Endoscopic resection of colorectal nonpolypoid lesions requires adequate submucosal lifting of the lesion. OBJECTIVE: To evaluate a self-assembled hydro-jet system for tissue elevation to improve endoscopic resection of colorectal nonpolypoid lesions. DESIGN: Prospective study. SETTING: Single-center teaching hospital. MAIN OUTCOME MEASUREMENTS: Efficacy and safety of the hydro-jet system and rate of complete resection. RESULTS: The system was clinically applied in 31 patients to remove a total of 34 lesions throughout the colon. An adequate submucosal fluid cushion was achieved in all but 1 case without any lifting-associated complications. Complete endoscopic resection was possible in all 33 lifted lesions by using a snare. The size of the resected lesions ranged from 7 to 60 mm. Major intraprocedure bleeding occurred in only 1 case. No perforation or late bleeding was recorded. Histological examination showed a selective accumulation of fluid in the submucosa with edema and dissociation of submucosal structures, with no damage to the muscularis mucosa and very limited 'burn effect' hampering assessment of radial margins. LIMITATIONS: Lack of controls. CONCLUSIONS: This inexpensive system allows safe and rapid submucosal lifting of colorectal nonpolypoid lesions to assist endoscopic resection. [ABSTRACT FROM AUTHOR]

Background: Ustekinumab (UST) is an interleukin-12/interleukin-23 receptor antagonist recently approved for treating ulcerative colitis (UC) but with limited real-world data. Therefore, we evaluated the effectiveness and safety of UST in patients with UC in a real-world setting., Research Design and Methods: This is a multicenter, retrospective, observational cohort study. The primary endpoints were the clinical remission rate (partial Mayo score, PMS, ≤1) and the safety of UST. Other endpoints were corticosteroid-free remission (CSFR) rate, clinical response rate (PMS reduction of at least 2 points), and fecal calprotectin (FC) reduction at week 24., Results: We included 256 consecutive patients with UC (M/F 139/117, median age 52). The clinical remission and clinical response rates at eight weeks were 18.7% (44/235) and 53.2% (125/235), respectively, and 27.6% (42/152) and 61.8% (94/152) at 24 weeks, respectively. At 24 weeks, CSFR was 20.3% (31/152), and FC significantly dropped at week 12 ( p  = 0.0004) and 24 ( p  = 0.038). At eight weeks, patients naïve or with one previous biologic treatment showed higher remission ( p  = 0.002) and clinical >response rates ( p  = 0.018) than patients previously treated with ≥ 2. Adverse events occurred in six patients (2.3%), whereas four patients (1.6%) underwent colectomy., Conclusion: This real-world study shows that UST effectively and safely treats patients with UC.

Background: Vedolizumab (VDZ) can be used to treat refractory ulcerative colitis (UC) and Crohn's disease (CD). We assessed whether there are differences in treating UC vs CD with VDZ., Research Design and Methods: Mayo score in UC and the Harvey-Bradshaw Index (HBI) in CD scored the clinical activity. Achievement and maintenance of clinical remission during the follow-up, and safety were the primary endpoints., Results: 729 patients (475 with UC and 254 with CD), median follow-up of 18 (IQR 6-36) months, were enrolled. Clinical remission at the 6 th month of treatment was achieved in 488 (66.9%) patients (74.4% in CD vs 62.9% in UC, p<0.002) while, during the follow-up, no difference was found (81.5% in the UC group and 81.5% pts in the CD group; p=0.537). The clinical remission at the 6 th month of treatment (p=0.001) and being naïve to biologics (p<0.0001) were significantly associated with prolonged clinical remission. The clinical response was significantly higher in UC (90.1%) vs CD (84.3%) (p=0.023), and surgery occurred more frequently in CD (1.9% in UC vs 5.1% in CD, p=0.016)., Conclusion: We found differences when using VDZ in UC vs CD in real life. These parameters can help the physician predict this drug's longterm efficacy.

Background: Adalimumab (ADA) biosimilars have entered the therapeutic armamentarium of inflammatory bowel disease (IBD), allowing for the treatment of a greater number of patients for their reduced cost than the originator. However, comparative data on the efficacy and safety of the various ADA biosimilars remains scarce.We compare the efficacy and safety of ADA biosimilars SB5, ABP501, GP2017, and MSB11022 in treating IBD outpatients in a real-life Italian setting., Methods: A retrospective analysis was performed on consecutive IBD outpatients with complete clinical, laboratory, and endoscopic data. Clinical activity was measured using the Mayo score in ulcerative colitis (UC) and the Harvey-Bradshaw Index in Crohn's disease (CD). The primary endpoints were the following: (1) induction of remission in patients new to biologics and patients new to ADA but previously exposed to other anti-tumor necrosis factor agents or other biologics; (2) maintenance of remission in patients switched from the ADA originator to an ADA biosimilar; and (3) safety of various biosimilars., Results: A total of 533 patients were enrolled according to the inclusion criteria: 162 patients with UC and 371 patients with CD. Clinical remission was obtained in 79.6% of patients new to biologics and 59.2% of patients new to ADA but not to other biologics; clinical remission was maintained in 81.0% of patients switched from the originator, and adverse events were recorded in 6.7% of patients. There was no significant difference between the 4 ADA biosimilars for each predetermined endpoint., Conclusions: Adalimumab biosimilars are effective and safe in IBD treatment, both in new patients and in patients switched from the ADA originator. No difference in efficacy and safety was found between ADA biosimilars., (© The Author(s) 2022. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background and Aims: Adalimumab (ADA) biosimilars have been included into the therapeutic armamentarium of inflammatory bowel disease (IBD); however, comparative data on the efficacy and safety of the different ADA biosimilars after replacing the ADA originator for a non-medical reason remains scarce. We aimed to compare in a real-life setting the efficacy and safety of four ADA biosimilars SB5, APB501, GP2017, and MSB11022 in IBD patients after replacing the originator for a non-medical reason., Methods: A multicenter retrospective study was performed on consecutive IBD patients, analyzing clinical, laboratory, and endoscopic data. The primary endpoints of the study were maintenance of clinical remission and safety of the different biosimilars., Results: 153 patients were enrolled, 26 with UC and 127 with CD. Clinical remission was maintained in 124 out of 153 (81%) patients after a median (IQR) follow-up of 12 (6-24) months, without any significant difference between the four ADA biosimilars. ADA biosimilars dosage was optimized in five patients (3.3%). Loss of remission was significantly higher in UC patients (10/26 patients, 38.5%) than in CD patients (19/127 patients, 14.9%, p<0.025). Adverse events occurred in 12 (7.9%) patients; the large majority were mild., Conclusions: No difference in efficacy and safety was found between ADA biosimilars when used to replace the ADA originator for a non-medical reason. However, in UC patients the replacement of ADA originator for this reason should be carefully assessed.

Background: To compare the performances of Infliximab (IFX) biosimilar CT-P13 and SB2 in the treatment of Inflammatory Bowel Diseases (IBD) outpatients in Italy., Research Design and Methods: Three hundred and eighty IBD outpatients were retrospectively evaluated. The primary endpoint was to compare the two IFX biosimilars in terms of reaching and maintenance of remission at any timepoint., Results: 197 patients with Ulcerative Colitis (UC) and 183 patients with Crohn's Disease (CD) treated with CT-P13 or SB2 and having a median (IQR) follow-up of 12 (6-36) months were compared: 230 (60.5%) were naïve to anti-TNFα, 20 (5.26%) were switched from IFX originator or from IFX CT-P13 to IFX SB2. Clinical remission was achieved in 133 (67.5%) UC patients and in 164 (89.6%) CD patients (p < 0.000), with no differences between CT-P13 and SB2 in the rate of remission in UC (p = 0.667) and CD (p = 0.286). Clinical response, steroid-free remission, rate of surgery, mucosal healing (MH) in UC, switching from IFX originator or from other biosimilar, and safety were similar. Higher MH rate was obtained in CD patients treated with CT-P13 (p = 0.004)., Conclusion: This first comparative study found that both IFX biosimilars CT-P13 and SB2 are effective and safe in managing IBD outpatients.

Objective: Moyamoya disease (MMD) is characterized by a progressive spontaneous occlusion of distal internal carotid arteries and its main branches. It is necessary to promptly diagnose and treat this condition, especially in children, because of the high risk of stroke and consequent severe disability. In this study, we examine the role of multiple burr-hole surgery (MBHS) in the treatment of pediatric patients with MMD and quasi-MMD and the role of perfusion magnetic resonance imaging (MRI) in the surgical indication and during follow-up., Methods: We reviewed preoperative, early postoperative, and late postoperative MRI perfusion and digital subtraction angiography images together with clinical and surgical outcomes in 10 children with MMD treated by MBHS., Results: Fourteen MBHS procedures (6 unilateral, 2 bilateral, and 2 single-setting bilateral) were performed in 10 children. Clinical and radiologic follow-up for all patients ranges from 16 months to 7 years. No ischemic events (transient ischemic attacks or stroke) occurred during the follow-up period. Postoperative digital subtraction angiography showed good revascularization around the burr-hole sites in all patients. The functional efficacy of the surgery was confirmed by dynamic susceptibility contrast perfusion MRI studies in 8 patients., Conclusions: Our data underline the good rate of success of MBHS in pediatric MMD and quasi-MMD. This technique results in good collateral revascularization, improved cerebral perfusion and excellent short and long-term symptoms control, with low perioperative risk. Postoperative changes of perfusion parameters and ivy sign MRI finding seem to show a positive correlation and mainly occur in posterior middle cerebral artery territory., (Copyright © 2019. Published by Elsevier Inc.)

Human cases of gastric anisakiasis caused by the zoonotic parasite Anisakis pegreffii are increasing in Italy. The disease is caused by ingestion of larval nematodes in lightly cooked or raw seafood. Because symptoms are vague and serodiagnosis is difficult, the disease is often misdiagnosed and cases are understimated.

Purpose: The purpose of this study is to evaluate an endoscopic trimodal imaging (ETMI) system (high resolution, autofluorescence, and NBI) in the detection and differentiation of colorectal adenomas., Methods: A prospective randomised trial of tandem colonoscopies was carried out using the Olympus XCF-FH260AZI system. Each colonic segment was examined twice for lesions, once with HRE and once with AFI, in random order per patient. All detected lesions were assessed with NBI for pit pattern and with AFI for colour. All lesions were removed and sent for histology. Any lesion identified on the second examination was considered as missed by the first examination. Outcome measures are adenoma miss rates of AFI and HRE, and diagnostic accuracy of NBI and AFI for differentiating neoplastic from non-neoplastic lesions., Results: Ninety-four patients underwent colonoscopy with ETMI (47 in each group). Among 47 patients examined with AFI first, 31 adenomas in 15 patients were detected initially [detection rate 0.66 (0.52-0.75)]. Subsequent HRE inspection identified six additional adenomas. Among 47 patients examined with HRE first, 29 adenomas in 14 patients were detected initially [detection rate 0.62 (0.53-0.79)]. Successive AFI yielded seven additional adenomas. Adenoma miss rates of AFI and HRE were 14% and 16.2%, respectively (p = 0.29). Accuracy of AFI alone for differentiation was lower than NBI (63% vs. 80%, p < 0.001). Combined use of AFI and NBI achieved improved accuracy for differentiation (84%), showing a trend for superiority compared with NBI alone (p = 0.064)., Conclusions: AFI did not significantly reduce the adenoma miss rate compared with HRE. AFI alone had a disappointing accuracy for adenoma differentiation, which could be improved by combination of AFI and NBI.

Purpose: The aim of this study is to assess the capability of endocytoscopy (ECS) in differentiating neoplastic from nonneoplastic lesions in the colorectum and to validate an ECS classification., Methods: Patients with colorectal polypoid and nonpolypoid lesions < or =10 mm were prospectively included. ECS classification subgrouped nonneoplastic (EC 0) and neoplastic (EC 1-3) lesions. Lesions were observed at super-magnified view (450x) before endoscopic resection. Blinded pathological assessment was obtained., Results: Fifty-two lesions were examined in 49 patients (17 polypoid and 35 nonpolypoid). Final pathological diagnosis was normal mucosa or hyperplastic polyp in ten cases, low-grade adenoma in 29, high-grade adenoma in 11, and submucosal invasive cancer in two cases. Positive predictive values of each EC group were 100%, 93.1%, 90.1%, and 100%, respectively. ECS diagnosis correlated completely with pathology in the differentiation between neoplastic and nonneoplastic lesions., Conclusions: ECS enabled observation of colorectal lesion at a subcellular level in vivo. The classification of ECS images had a good correlation with the final pathological diagnosis. ECS was useful to differentiate between neoplastic and nonneoplastic lesions.

Authors report the available scientific evidence on the role of proton pump inhibitors and upper gastro-intestinal endoscopy in the management of patients with gastro-oesophageal reflux disease. Relative indications, advantages and pitfalls of various diagnostic and therapeutic strategies for cost-effective management of this condition are discussed. The most recent evidence-based guidelines are outlined.

Background: Endoscopic variceal ligation is an established procedure for eradication of esophageal varices. However, varices frequently recur after endoscopic variceal ligation. Argon plasma coagulation has been used as supplemental treatment for eradication of varices and for prevention of variceal recurrence in small uncontrolled series. The aim of this study was to determine whether argon plasma coagulation is effective in reducing variceal recurrence after endoscopic variceal ligation., Methods: Thirty patients with cirrhosis, a history of acute esophageal variceal bleeding, and eradication of varices by endoscopic variceal ligation were randomized to argon plasma coagulation (16 patients) or observation (14 patients). The 2 groups were similar with respect to all background variables including age, Child-Pugh score, presence of gastric varices, and degree of portal hypertensive gastropathy. In the argon plasma coagulation group, the entire esophageal mucosa 4 to 5 cm proximal to the esophagogastric junction was thermocoagulated circumferentially with argon plasma coagulation in 1 to 3 sessions performed at weekly intervals. Endoscopy was performed every 3 months to check for recurrence of varices in both groups., Results: During the course of the study, no serious complication was noted. After argon plasma coagulation, transient fever occurred in 13 patients and 8 complained of dysphagia or retrosternal pain/discomfort. Mean follow-up for all patients was 16 months (range 9-28 months). No recurrence of varices or variceal hemorrhage was observed in the argon plasma coagulation group, whereas varices recurred in 42.8% (6/14) of the patients in the control group (p < 0.04) and bleeding recurred in 7.2% (1/14)., Conclusions: Argon plasma coagulation of the distal esophageal mucosa after eradication of esophageal varices by endoscopic variceal ligation is safe and effective for reducing the rate of variceal recurrence.

Background: Endoscopic application of hemoclips (HC) was prospectively compared with heat probe (HP) treatment in patients with bleeding ulcers., Methods: One hundred thirteen patients with major stigmata of ulcer hemorrhage were randomly assigned to receive HP (n = 57) or HC (n = 56). Clinical and endoscopic features were comparable in both groups. Recurrent bleeding was retreated with the modality previously used. Patients in whom treatment or retreatment was unsuccessful underwent emergency surgery., Results: Hemostasis, adequate treatment of visible vessel, 30-day mortality, and emergency surgery rates were similar for both groups. Recurrent bleeding was 21% for HP and 1.8% for HC (p < 0.05). Length of hospital stay and transfusion requirements were significantly lower in the HC group. There was no evidence of clip-induced tissue injury or impaired ulcer healing. Clips dislodged spontaneously in most patients within 8 weeks of treatment. No further hemorrhage occurred on a median follow-up of 11 months (range 1-23)., Conclusions: The hemoclip is safe and effective in the treatment of severe ulcer bleeding and is superior to HP in preventing early recurrent bleeding.

The capacity of filgrastim to reduce the myelotoxicity of a 16-week intensive chemotherapy regimen has been investigated in 24 operable breast cancer patients with > or = 10 metastatic axillary nodes. Five patients were treated with chemotherapy alone (control group); 19 patients were treated with chemotherapy and filgrastim, 5 microg/kg/day s.c. Six patients in the latter group were treated from day 4 to day 7 (level 1), seven from day 10 to day 13 (level 2), and six from day 4 to day 7 and day 10 to day 13 (level 3). A total of 135 courses were administered: neutropenia was the most severe toxicity, and the prophylactic use of filgrastim does not reduce its severity. Moreover, the dose intensities of antiblastic drugs actually received by the patients were not significantly different in the four study groups. Among the patients treated at level 3, there were three toxic deaths: one patient died because of febrile neutropenia and sepsis, two patients because of ischemic colitis. At a median follow-up of 15 months, 17 patients were alive, and 15 patients were disease free. The use of filgrastim does not ameliorate myelotoxicity and does not allow the administration of the planned doses of antiblastic drugs of a 16-week intensive chemotherapy regimen.

In this analysis of the data from a longitudinal study on coronary heart disease risk factors, it was found that participants screened a few weeks after a major disaster (earthquake) had a higher heart rate, serum cholesterol levels, and serum triglyceride levels than matched participants that were screened shortly before the catastrophic event. The two groups of participants did not differ with regard to their characteristics at the baseline examination carried out 5 years previously. The lack of difference in blood pressure between exposed and nonexposed participants could be explained by the lag-time between the earthquake and the blood pressure measurements. We conclude that the acute stress associated with major disasters can influence risk factors for coronary heart disease. Permanent elevation of these risk factors due to the disruption of the social environment of the individuals affected by major disasters might be responsible for the apparent long-term adverse effects on cardiovascular mortality discussed previously in the literature.