Long-term outcomes after endoscopic removal of malignant colorectal polyps: Results from a 10-year cohort.

BACKGROUND: Choosing an optimal post-polypectomy management strategy of malignant colorectal polyps is challenging, and evidence regarding a surveillance-only strategy is limited. AIM: To evaluate long-term outcomes after endoscopic removal of malignant colorectal polyps. METHODS: A single-center retrospective cohort study was conducted to evaluate outcomes after endoscopic removal of malignant colorectal polyps between 2010 and 2020. Residual disease rate and nodal metastases after secondary surgery and local and distant recurrence rate for those with at least 1 year of follow-up were investigated. Event rates for categorical variables and means for continuous variables with 95% confidence intervals were calculated, and Fisher's exact test and Mann-Whitney test were performed. Potential risk factors of adverse outcomes were determined with univariate and multivariate logistic regression models. RESULTS: In total, 135 lesions (mean size: 22.1 mm; location: 42% rectal) from 129 patients (mean age: 67.7 years; 56% male) were enrolled. The proportion of pedunculated and non-pedunculated lesions was similar, with en bloc resection in 82% and 47% of lesions, respectively. Tumor differentiation, distance from resection margins, depth of submucosal invasion, lymphovascular invasion, and budding were reported at 89.6%, 45.2%, 58.5%, 31.9%, and 25.2%, respectively. Residual tumor was found in 10 patients, and nodal metastasis was found in 4 of 41 patients who underwent secondary surgical resection. Univariate analysis identified piecemeal resection as a risk factor for residual malignancy (odds ratio: 1.74; P = 0.042). At least 1 year of follow-up was available for 117 lesions from 111 patients (mean follow-up period: 5.59 years). Overall, 54%, 30%, 30%, 11%, and 16% of patients presented at the 1-year, 3-year, 5-year, 7-year, and 9-10-year surveillance examinations. Adverse outcomes occurred in 9.0% (local recurrence and dissemination in 4 patients and 9 patients, respectively), with no difference between patients undergoing secondary surgery and surveillance only. CONCLUSION: Reporting of histological features and adherence to surveillance colonoscopy needs improvement. Long-term adverse outcome rates might be higher than previously reported, irrespective of whether secondary surgery was performed.

Accuracy of the Pancolonic Modified Mayo Score in predicting the long-term outcomes of ulcerative colitis: a promising scoring system.

Background: Different endoscopic scoring systems for assessing ulcerative colitis (UC) severity are available. However, most of them are not correlated with disease extent. Objectives: Our study aimed to compare the predictive value of the PanMay score versus the endoscopic Mayo (MES), Ulcerative Colitis Endoscopic Index of Severity (UCEIS), and Dublin score in predicting long-term outcomes of UC. Design: This retrospective study enrolled consecutive UC patients who underwent colonoscopy before at least a 3-year follow-up. Methods: The PanMayo, MES, UCEIS, and Dublin scores and the baseline clinical and demographic characteristics of the participants were assessed. Endpoints were disease flare that required novel biological therapy, colectomy, and hospitalization. Patients were stratified using baseline clinical activity. Results: Approximately 62.8% of the 250 enrolled patients were in clinical remission. In these patients, the PanMayo, MES, and Dublin scores were positively associated with the risk of clinical flare. The MES score increased with clinical flare. The PanMayo score (>12 points), but not the MES score, was associated with the need for novel biological initiation and biological escalation. Furthermore, the Dublin and UCEIS scores of patients in remission who need novel biological treatment had a similar trend. Colectomy risk was associated with PanMayo and Dublin scores. Conclusion: The combined endoscopic assessment of disease extent and severity can be more accurate in predicting outcomes among patients with UC. PanMayo score can be utilized in addition to the existing scoring systems, thereby leading to a more accurate examination. Summary: UC endoscopic scores do not assess extension. Our study aimed to analyze the predictive value of the PanMayo score. Based on 250 patients, results showed that the long-term disease outcomes of UC could be predicted with the PanMayo score more accurately.

Co-Administration of Proton Pump Inhibitors May Negatively Affect the Outcome in Inflammatory Bowel Disease Treated with Vedolizumab.

Concomitant medications may alter the effect of biological therapy in inflammatory bowel disease. The aim was to investigate the effect of proton pump inhibitors on remission rates in patients with inflammatory bowel disease treated with the gut-selective vedolizumab. Patients from the Hungarian nationwide, multicenter vedolizumab cohort were selected for post hoc analysis. Primary outcomes were the assessment of clinical response and endoscopic and clinical remission at weeks 14 and 54. Secondary outcomes were the evaluation of the combined effect of concomitant steroid therapy and other factors, such as smoking, on remission. A total of 108 patients were identified with proton pump inhibitor data from 240 patients in the original cohort. Patients on steroids without proton pump inhibitors were more likely to have a clinical response at week 14 than patients on concomitant PPI (95% vs. 67%, p = 0.005). Non-smokers with IBD treated with VDZ were more likely to develop a clinical response at week 14 than smokers, particularly those not receiving PPI compared with patients on co-administered PPI therapy (81% vs. 53%, p = 0.041, and 92% vs. 74%, p = 0.029, respectively). We found that the use of PPIs in patients treated with VDZ may impair the achievement of response in certain subgroups. Unnecessary PPI prescriptions should be avoided.

Risk Factors and Interpretation of Inconclusive Endoscopic Ultrasound-Guided Fine Needle Aspiration Cytology in the Diagnosis of Solid Pancreatic Lesions.

BACKGROUND: The inconclusive cytological findings of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) remain a major clinical challenge and often lead to treatment delays. METHODS: Patients who had undergone EUS-FNA sampling for solid pancreas lesions between 2014 and 2021 were retrospectively enrolled. The "atypical" and "non-diagnostic" categories of the Papanicolaou Society of Cytopathology System were considered inconclusive and the "negative for malignancy" category of malignancy was suspected clinically. We determined the frequency and predictors of inconclusive cytological finding. RESULTS: A total of 473 first EUS-FNA samples were included, of which 108 cases (22.83%) were inconclusive. Significant increases in the odds of inconclusive cytological findings were observed for lesions with a benign final diagnosis (OR 11.20; 95% CI 6.56-19.54, p < 0.001) as well as with the use of 25 G FNA needles (OR 2.12; 95% CI 1.09-4.01, p = 0.023) compared to 22 G needles. Furthermore, the use of a single EUS-FNA technique compared to the combined use of slow-pull and standard suction techniques (OR 1.70; 95% CI 1.06-2.70, p = 0.027) and less than three punctures per procedure led to an elevation in the risk of inconclusive cytology (OR 2.49; 95% CI 1.49-4.14, p < 0.001). Risk reduction in inconclusive cytology findings was observed in lesions between 2-4 cm (OR 0.40; 95% CI 0.23-0.68, p = 0.001) and >4 cm (OR 0.16; 95% CI 0.08-0.31, p < 0.001) compared to lesions ≤2 cm. CONCLUSIONS: The more than two punctures per EUS-FNA sampling with larger-diameter needle (19 G or 22 G) using the slow-pull and standard suction techniques in combination may decrease the probability of inconclusive cytological findings.

Real-Life Efficacy of Tofacitinib in Various Situations in Ulcerative Colitis: A Retrospective Worldwide Multicenter Collaborative Study.

BACKGROUND AND AIMS: Tofacitinib (TFB) appears to be effective in the treatment of ulcerative colitis (UC); however, available real-world studies are limited by cohort size. TFB could be an option in the treatment of acute severe ulcerative colitis (ASUC). We aimed to investigate efficacy and safety of TFB in moderate-to-severe colitis and ASUC. METHODS: This retrospective, international cohort study enrolling UC patients with ≥6-week follow-up period was conducted from February 1 to July 31, 2022. Indications were categorized as ASUC and chronic activity (CA). Baseline demographic and clinical data were obtained. Steroid-free remission (SFR), colectomy, and safety data were analyzed. RESULTS: A total of 391 UC patients (median age 38 [interquartile range, 28-47] years; follow-up period 26 [interquartile range, 14-52] weeks) were included. A total of 27.1% received TFB in ASUC. SFR rates were 23.7% (ASUC: 26.0%, CA: 22.8%) at week 12 and 41.1% (ASUC: 34.2%, CA: 43.5%) at week 52. The baseline partial Mayo score (odds ratio [OR], 0.850; P = .006) was negatively associated with week 12 SFR, while biologic-naïve patients (OR, 2.078; P = .04) more likely achieved week 52 SFR. The colectomy rate at week 52 was higher in ASUC group (17.6% vs 5.7%; P < .001) and decreased with age (OR, 0.94; P = .013). A total of 67 adverse events were reported, and 17.9% resulted in cessation of TFB. One case of thromboembolic event was reported. CONCLUSIONS: TFB is effective in both studied indications. TFB treatment resulted in high rates of SFR in the short and long terms. Higher baseline disease activity and previous biological therapies decreased efficacy. No new adverse event signals were found.

[Endoscopic ultrasound in the lower gastrointestinal tract]. / Az alsó tápcsatornai endoszkópos ultrahangvizsgálat.

Endoscopic ultrasound is a minimally invasive modality that combines endoscopy with ultrasound, providing a possibility to visualize the wall of the gastrointestinal tract and adjacent tissues and organs. Since the development of the modality in the 1980s, advancements in endoscopic ultrasound technology have led to increasingly broadening indications: besides diagnostic indications, therapeutic indications have also expanded greatly. According to recent guidelines regarding rectal cancer staging, rectal ultrasonography is mainly considered to be a secondary imaging modality compared to magnetic resonance imaging. With the use of forward-viewing echoendoscopes and ultrasound miniprobes that can be inserted through the working channel of the endoscope, endoscopic ultrasound technology can be expanded to proximal, colonic areas as well. Rectal ultrasonography can also play an important role in the differential diagnosis of subepithelial lesions, in the detection of rectal varices, in the diagnosis of inflammatory bowel diseases as well as perianal complications. Diagnostic accuracy can further be improved with the addition of ultrasound-guided sampling in certain cases. Currently, therapeutic indications are more like promising possibilities, than part of everyday clinical practice, but this might change in the near future. The purpose of this review is to summarize the current indications of rectal ultrasound in the clinical practice, including diagnostic and therapeutic ones as well. Orv Hetil. 2023; 164(30): 1176-1186.

Nationwide experiences with trough levels, durability, and disease activity among inflammatory bowel disease patients following COVID-19 vaccination.

Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic has complicated the management of inflammatory bowel diseases (IBD). Objectives: This study aimed to assess the efficacy of different anti-SARS-CoV-2 vaccines under different treatments in IBD patients and identify predictive factors associated with lower serological response, including anti-tumor necrosis factor (anti-TNF) drug levels. Design: A prospective, double-center study of IBD patients was conducted following messenger ribonucleotide acid (mRNA) and non-mRNA anti-SARS-CoV-2 vaccination. Methods: Healthy control (HC) patients were enrolled to reduce bias. Baseline and control samples were obtained 14 days after the second dose to assess the impact of conventional and biological treatments. Clinical and biochemical activity, serological response level, and anti-TNF drug levels were measured. Results: This study included 199 IBD (mean age, 40.9 ± 12.72 years) and 77 HC participants (mean age, 50.3 ± 12.36 years). Most patients (76.9%) and all HCs received mRNA vaccines. Half of the IBD patients were on biological treatment (anti-TNF 68.7%). Biological and thiopurine combined immunomodulation and biological treatment were associated with lower serological response (p < 0.001), and mRNA vaccination promoted better antibody levels (p < 0.001). Higher adalimumab levels caused lower serological response (p = 0.006). W8 persistence of anti-SARS-CoV-2 level was equal in IBD and HC groups. Vaccination did not aggravate clinical disease activity (p = 0.65). Conclusion: Anti-SARS-CoV-2 vaccination is considerably efficacious in IBD patients, with mRNA vaccines promoting better antibody levels. The negative impact of combined biological treatment, especially with high adalimumab drug levels, on serological response to vaccination should be considered. Although midterm durability of vaccination is encouraging, more data are needed to expand the existing understanding on this issue.

Adjustment of COVID-19 vaccination to adalimumab trough level is considerable due to the reduced serological response. mRNA vaccination should be preferred in case of IBD patients with an equal durability of anti-SARS-CoV-2 level of subjects and healthy control participants.

Effects of bowel cleansing on the composition of the gut microbiota in inflammatory bowel disease patients and healthy controls.

Background: In patients with inflammatory bowel disease (IBD), Crohn's disease (CD), and ulcerative colitis (UC), numerous cases of exacerbations could be observed after colonoscopy, raising the possible pathogenetic effect of colonic microbiota alterations in IBD flare. Objectives: We aimed to investigate the changes in the fecal microbiota composition in IBD patients influenced by the bowel preparation with sodium picosulfate. Design: We enrolled patients with IBD undergoing bowel preparation for colonoscopy in the prospective cohort study. The control group (Con) comprised non-IBD patients who underwent colonoscopy. Clinical data, blood, and stool samples were collected before colonoscopy (timepoint A), 3 days later (timepoint B), and 4 weeks later (timepoint C). Methods: Disease activity and gut microbiota changes were assessed at each timepoint. Fecal microbiota structure - at family level - was determined by sequencing the V4 region of the 16S rRNA gene. Statistical analysis included differential abundance analysis and Mann-Whitney tests. Results: Forty-one patients (9 CD, 13 UC, and 19 Con) were included. After bowel preparation, alpha diversity was lower in the CD group than in the UC (p = 0.01) and Con (p = 0.02) groups at timepoint B. Alpha diversity was significantly higher in the UC group than in the CD and Con (p = 0.03) groups at timepoint C. Beta diversity difference differed between the IBD and Con (p = 0.001) groups. Based on the differential abundance analysis, the Clostridiales family was increased, whereas the Bifidobacteriaceae family was decreased in CD patients compared to the Con at timepoint B. Conclusions: Bowel preparation may change the fecal microbial composition in IBD patients, which may have a potential role in disease exacerbation after bowel cleansing.

Self-reported efficacy and safety of infliximab and adalimumab biosimilars after non-medical switch in patients with inflammatory bowel disease: results of a multicenter survey.

BACKGROUND: Few data are available on subjective disease control and perception of adverse events (AEs) during switching from original anti-TNF agents to biosimilars. RESEARCH DESIGN AND METHODS: Hungarian patients with inflammatory bowel disease were interviewed after a mandatory non-medical switch from an infliximab (IFX) originator to a biosimilar GP1111 or from an adalimumab (ADA) originator to a biosimilar GP2017. Drug choice was based on patient's and physician's decision. Subjective efficacy was measured using a 10-point scale, and AEs were assessed. Difference in efficacy before and after the switch was compared within and between the drugs. RESULTS: Seventy-three ADA and 106 IFX switching patients were interviewed. Subjective efficacy of IFX biosimilar was rated lower compared to IFX originator (8.72 ± 1.68 vs. 7.77 ± 2.34; p = 0.001). The ADA biosimilar was rated higher than its originator (9.02 ± 1.61 vs. 8.42 ± 1.93; p = 0.017). Patients receiving ADA biosimilar were more satisfied with the new treatment compared to IFX (p = 0.032). The incidence of new AEs was 85% in the ADA and 55% in the IFX group (1.79 vs. 0.93 AEs per patient, respectively, p < 0.001). CONCLUSION: Subjective efficacy of switching to a biosimilar was proven in case of ADA, while reduced efficacy was experienced with IFX biosimilar. Perception of AEs was high and varied between biosimilars.

[Cholangitis and cholecystitis: diagnostic criteria and management]. / Epeút- és epehólyag-gyulladás: diagnosztikus kritériumok és terápia.

In developed countries, diseases of the gallbladder and the biliary tract count as some of the most frequent gastrointestinal disorders. The inflammation of the gallbladder/biliary tree is a potentially severe, even lethal condition that requires rapid diagnosis and early multidisciplinary approach to be treated. Although the frequency of these diseases is high, the treatment is not unified in Hungary yet. The aim of the evidence-based recommendation is to clarify the diagnostic criteria and severity grading of these diseases and to highlight the indications and rules of proper application of the numerous available therapeutic interventions. The recent guideline is based on the consensus of the Board members of the Endoscopic Section of the Hungarian Gastroenterology Society in contribution with renown experts of surgery, infectology as well as interventional radiology and it counts as a clear and easy applicable guide during the all-day healthcare practice. Our guidelines are based on Tokyo guidelines established on the basis of the consensus reached in the International Consensus Meeting held in Tokyo which were revised in 2013 (TG13) and in 2018 (TG18). Orv Hetil. 2023; 164(20): 770-787.

Impact of neoadjuvant FLOT treatment of advanced gastric and gastroesophageal junction cancer following surgical therapy.

Introduction: Therapeutic treatment for advanced-stage (T2-T4) gastroesophageal junction (GEJ) and gastric cancer involves neoadjuvant chemotherapy with subsequent surgical intervention. Method: Neoadjuvant oncological treatment for GEJ and gastric cancer previously consisted of the intravenous administration of epirubicin, cisplatin and fluorouracil (ECF) or epirubicin, cisplatin and capecitabine (ECX) combination (Group 1). The new protocol (FLOT, F: 5-FU, L: leucovorin, O: oxaliplatin, T: docetaxel), included patients with resectable GEJ and gastric cancer who had a clinical stage cT2 or higher nodal positive cN+ disease (Group 2). Between 31 December 2008 and 31 October 2022, the effect of different oncological protocols in terms of surgical outcomes in cases of T2-T4 tumours were retrospectively evaluated. Results of randomly assigned patients from the earlier ECF/ECX protocol (n = 36) (Group 1) and the new FLOT protocol (n = 52) (Group 2) were compared. Effect of different neoadjuvant therapies on tumour regression, types of possible side effects, type of surgery, and oncological radicality of surgical procedures were analysed. Results: When comparing the two groups, we found that in case of the FLOT neoadjuvant chemotherapy (Group 2, n = 52), complete regression was achieved in 13.95% of patients, whereas in the case of ECF/ECX (Group 1, n = 36), complete regression occurred in only 9.10% of patients. Furthermore, in the FLOT group, the mean number of lymph nodes removed was slightly higher (24.69 vs. 20.13 in the ECF/ECX group). In terms of the safety resection margin (proximal), no significant difference was found between the two treatment groups. Nausea and vomiting were the most common side effects. The occurrence of diarrhea was significantly higher in the FLOT group (p = 0.006). Leukopenia and nausea occurred more commonly with the old protocol (Group 1). The rate of neutropenia was lower following FLOT treatment (p = 0.294), with the lack of grade II and III cases. Anaemia occured at a significantly higher rate (p = 0.036) after the ECF/ECX protocol. Conclusions: As a result of the FLOT neoadjuvant oncological protocol for advanced gastro-esophageal junction and gastric cancer, the rate of complete tumour regression increased significantly. The rate of side effects was also appreciably lower following the FLOT protocol. These results strongly suggest a significant advantage of the FLOT neoadjuvant treatment used before surgery.

Comparison of therapeutic efficacy and treatment costs of self-expandable metal stents and plastic stents for management of malignant biliary obstruction.

BACKGROUND: According to the European Society of Gastrointestinal Endoscopy guidelines, self-expandable metal stents (SEMSs) are preferable to plastic stents (PSs) in the management of pancreatic cancer, regardless of cancer stage. The aim of this study was to compare the therapeutic efficacy and treatment costs of SEMS and PS in the management of malignant biliary obstruction. METHODS: One hundred and thirty-five patients who underwent endoscopic stent placement were retrospectively enrolled and divided into PS (41 patients), primary SEMS (39 patients) and secondary SEMS (55 patients) groups. We determined the technical and functional success rate, stent patency, and cumulative treatment cost. RESULTS: A total of 111 SEMSs and 153 PSs were placed with similar technical (100% vs. 98.69%) and functional success rate (90.10% vs. 86.27%) but with different stent patency (10.28 vs. 22.16 weeks; p < 0.001). Multiple PS implantations and larger stent diameter increased the length of stent patency compared to 7-Fr PSs (10.88 vs. 10.55 vs. 7.63 weeks, respectively). The cumulative treatment cost of patients with different survival times did not differ significantly between groups, however, among patients surviving 2-4 months it was higher in PS group than primary SEMS and secondary SEMS groups (2888€ vs. 2258€ vs. 2144€, respectively, p = 0.3369) due to increased number of biliary reintervention (2.08 ± 1.04 vs. 1.20 ± 0.42 vs. 1.50 ± 0.53; p < 0.0274) and longer hospital stay (15.77 ± 10.14 vs. 8.70 ± 7.70 vs. 8.50 ± 6.17 days, p = 0.0527). CONCLUSIONS: In view of treatment costs, the consequences of illness, and the processes of the health care system, SEMS implantation is recommended regardless of patients' life expectancy.

Possible genetical predictors of efficacy and safety of budesonide-MMX in patients with mild-to-moderate ulcerative colitis, and safety comparison with methylprednisolone.

BACKGROUND: Budesonide-MMX is a topically active corticosteroid degraded by cytochrome-P450 enzymes, resulting in favorable side-effect profile. We aimed to assess the effect of CYP genotypes on safety and efficacy, and make a direct comparison with systemic corticosteroids. RESEARCH DESIGN AND METHODS: We enrolled UC patients receiving budesonide-MMX and IBD patients on methylprednisolone in our prospective, observational-cohort study. Before and after treatment regimen clinical activity indexes, laboratory parameters (electrolytes, CRP, cholesterol, triglyceride, dehydroepiandrosterone, cortisol, beta-crosslaps, osteocalcin), and body composition measurements were assessed. CYP3A4 and CYP3A5 genotypes were determined in the budesonide-MMX group. RESULTS: 71 participants were enrolled (budesonide-MMX: 52; methylprednisolone: 19). CAI decreased (p<0.05) in both groups. Cortisol decreased (p<0.001), and the level of cholesterol was elevated in both groups (p<0.001). Body composition altered only following methylprednisolone. Bone homeostasis (osteocalcin; p<0.05) and DHEA (p<0.001) changed more prominently after methylprednisolone. Glucocorticoid-related adverse events were more common following methylprednisolone treatment (47.4% compared to 1.9%). CYP3A5(*1/*3) genotype positively influenced efficacy, but not safety. Only one patient's CYP3A4 genotype differed. CONCLUSIONS: CYP genotypes can affect the efficacy of budesonide-MMX; however, further studies would be needed with analyses of gene expression. Although budesonide-MMX is safer than methylprednisolone, due to glucocorticoid-related side effects, admission should require greater precaution.

The use of ultrasound in colonic and perianal diseases.

PURPOSE OF REVIEW: To revise recent literature findings regarding the use of ultrasound in colonic and perianal diseases by focusing particularly on its feasibility in inflammatory bowel diseases (IBD), colorectal neoplastic lesions, and perineal diseases, with further highlight on interventional capabilities. RECENT FINDINGS: Treat-to-target approach in IBD raised an interest in intestinal ultrasound (IUS) for monitoring bowel activity considering its noninvasive nature, low costs, and well tolerability. New IUS indices have been developed with ever better methodologies and are at various stage of validation. A standardized over-the-wire technique for colonic US using a flexible overtube enables endoscopic ultrasound (EUS)-guided tissue sampling beyond the rectum, and forward-viewing radial-array echoendoscopes can assist identification of early neoplastic lesions in proximal colon. Intraoperative ultrasound and contrast-enhanced ultrasound carry an additional diagnostic value compared to conventional preoperative imaging modalities in detecting colorectal cancer liver metastases (CRLM). SUMMARY: The feasibility of IUS in monitoring IBD activity is supported by growing evidence, but uniform IUS indices are still lacking. Recent advancements in EUS are expanding capabilities for determining depth of invasion of colorectal neoplasms, tissue sampling, and EUS-guided interventions to the entire colon. Ultrasonography can be a valuable tool in CRLM diagnostics as well.

Conception and reality: Outcome of SARS-CoV-2 infection and vaccination among Hungarian IBD patients on biologic treatments.

Introduction: Inflammatory bowel disease potentially elevates the risk of infections, independently from age, while the disease activity and medical treatment(s) can also increase the risks. Nevertheless, it is necessary to clarify these preconceptions as well during the COVID-19 pandemic. Methods: An observational, questionnaire based study was conducted in Hungary between February and August 2021. 2 questionnaires were completed. The first questionnaire surveyed the impact of the pandemic on patients with biologic treatments and assessed the severity and outcome of the infection, whereas the second one assessed vaccination rate and adverse events. Results: 472 patients participated in the study. 16.9 % of them acquired the infection and 6.3 % needed hospitalization. None of them required ICU care. Male sex elevated the risk of infection (p = 0.008), while glove (p = 0.02) and mask wearing (p = 0.005) was the most effective prevention strategy. Nevertheless, abstaining from community visits or workplace did not have an impact on the infection rate. Smoking, age, and disease type did not elevate the risk. UC patients had poorer condition during the infection (p = 0.003); furthermore, the disease activity could potentially worsen the course of infection (p = 0.072). The different biological treatments were equally safe; no difference was observed in the infection rate, course of COVID-19. Azathioprine and corticosteroids did not elevate the infection rate. 28 patients (35.0 %) suspended the ongoing biologic treatment, but it had no impact on the disease course. However, it resulted in changing the current treatment (p = 0.004). 9.8 % of the respondents were sceptic about being vaccinated, and 90 % got vaccinated. In one case, a serious flare-up occurred. Discussion: Most patients acquired the infection at workplace. Biologic therapies had no effect on the COVID-19 infection, whereas male sex, an active disease, and UC could be larger threat than treatments. Vaccination was proved to be safe, and patient education is important to achieve mass vaccination of the population.

Clinical benefits of oral capecitabine over intravenous 5-fluorouracyl regimen in case of neoadjuvant chemoradiotherapy followed by surgery for locally advanced rectal cancer.

Background: During the last decade, one of the most important treatment options for locally advanced, potencially resectable rectal tumours was neoadjuvant chemoradiotherapy (CRT) followed by surgery. Methods: Effects of the neoadjuvant treatment on surgical outcomes were retrospectively analysed in 185 patients with stage T2-T4 and N0-2, resectable rectal tumour among two patient groups defined by radiosensitizer agents. Group 1 (n = 94) involved radiotherapy (RT) with 50.4 Gy total dose (25 × 1.8 Gy + 3 × 1.8 Gy tumour bed boost), and intravenous 5-fluorouracil (5-FU) (350 mg/m2) with leucovorin (20 mg/m2) on the 1-5 and 21-25 days, while Group 2 (n = 91) RT and orally administrated capecitabine (daily 2 × 825 mg/m2) on RT days. Surgery was carried out after 8-10 weeks. Side effects, perioperative complications, type of surgery, number of removed regional lymph nodes, resection margins and tumour regression grade (TRG) were analysed. Results: More favourable side effects were observed in Group 2. Despite the same rate of diarrhoea (Group 1 vs. Group 2: 54.3% vs. 56.0%), Grade 2-3 diarrhoea ratio was lower (p = 0.0352) after capecitabine (Group 2). Weight loss occurred in 17.0% and 2.2% (p = 0.00067), while nausea and vomiting was described in 38.3% and 15.4% (p = 0.00045) with 5-FU treatment and capecitabine respectively. Anaemia was observed in 33.0% and 22.0% (p = 0.0941). Complete tumour regression occurred in 25.3% after oral- and 13.8% after intravenous treatment (p = 0.049). Ratio of sphincter preservation was higher with laparoscopy than open surgery (72.3% vs. 39.7%) (p = 0.00001). Conclusion: The study confirms advantages of neoadjuvant chemoradiotherapy with oral capecitabine for rectal tumours, such as more favourable side effect profile and overall clinical outcome, with increased rate of complete tumour regression.

Infection risk related to gastrointestinal endoscopic procedures during the SARS-CoV-2 pandemic / Tápcsatornai endoszkópos eljárásokkal összefüggo infekciós kockázat a SARS-CoV-2-járvány idején

Introduction: COVID­19 significantly affects endoscopic labs' workflow. Endoscopic examinations are considered high-risk for virus transmission. Objectives: To determine impact of COVID­19 pandemic on Hungarian endoscopic labs' workflow and on infection risk of endoscopic staff. Method: A nation-wide, cross-sectional online questionnaire was sent to heads of endoscopic labs in Hungary. The average number (with 95% confidence intervals) of upper and lower gastrointestinal endoscopies performed in 2020 was compared to that in 2019. The number of SARS-CoV-2-infected endoscopic staff members and the source of infection was also investigated. Results: Completion rate was 30% (33/111). Neither the number of upper (1.593 [743­1.514] vs. 1.129 [1.020­2.166], p = 0.053), nor that of lower gastrointestinal endoscopies (1.181 [823­1.538] vs. 871 [591­1.150], p = 0.072) decreased in 2020, but both upper and lower gastrointestinal endoscopies' number decreased by 80% during peak phases. Separate examination room was available in 12% of institutes. Appropriate quality personal protective equipment (PPE) was available during the first and second peak phase in 70% and 82%, respectively. Infection risk stratification by questionnaire and PCR testing was routinely performed in 85% and 42%, respectively. Employee number decreased by 33% and 26% for physicians, and by 19% and 21% for assistants during peak phases, mainly due to age restrictions and COVID care assignments. 32% of assistants and 41% of physicians were infected (associated with inappropriate PPE use in 16% and 18%, respectively). Conclusion: Peak phases' restrictions increase endoscopic workload afterwards. Despite PPE availability, 15% of employees' COVID infection resulted from inappropriate PPE use in pre-vaccination era.

Short term results of the FLOT neoadjuvant therapy on the surgical management of advanced gastro-oesophageal junction adenocarcinoma / A neoadjuvans FLOT-terápia hatása az elorehaladott gyomor-cardia tumorok rövid távú onkológiai és sebészi kezelés eredményeire

Introduction. Recently the therapeutic treatment for advanced, stage T2-T4 gastro-oesophageal junction cancer and those adjacent to the regional lymph nodes involves neoadjuvant chemotherapy with subsequent surgical intervention. Method. Neoadjuvant oncological treatment for gastro-oesophageal junction cancer previously consisted of the intravenous administration of epirubicin, cisplatin and fluorouracil (ECF) or epirubicin, cisplatin and capecitabine (ECX) combination (Group I). In the course of the new protocol (FLOT-, F: 5-FU, L: leucovorin, O: oxaliplatin, T: docetaxel), patients were included with resectable gastro-oesophageal junction cancer who had a clinical-stage cT2 or higher nodal positive cN+ disease (Group II). Between 31st of December 2013 and 1st of June 2021 we retrospectively analyzed the effect of these FLOT oncological protocols in terms of surgical outcomes in cases of T2-T4 tumors (n = 9). We compared the results of the randomly assigned nine patients from earlier ECF/ECX protocol (Group I). We analyzed the effect of the different neoadjuvant therapy on tumor regression, and evaluated the types of possible side effects, type of surgery, and the oncological radicality of surgical procedures (number of removed regional lymph nodes, resection margins). Results. Comparing the two groups we found that in cases of FLOT neoadjuvant chemotherapy complete regression was achieved significantly a higher number like in earlier ECX/ECF therapy. Furthermore, the average number of removed lymph nodes, and the safety resection margins (distal, circumferential) no significant difference was found between the two groups. Neutropenia was the most frequently encountered side effect. Leukopenia, neutropenia and nausea occurred more frequently in cases of the old protocol (Group I). Conclusions. As a result of the FLOT neoadjuvant oncological protocol for advanced gastro-oesophageal junction cancer, the number of cases with complete tumor regression has significantly increased. The present results strongly suggest a significant advantage in favor of FLOT neoadjuvant treatment following surgery. The prevalence of side effects was also appreciably lower in cases of the FLOT protocol.

Ustekinumab is associated with superior treatment persistence but not with higher remission rates versus vedolizumab in patients with refractory Crohn's disease: results from a multicentre cohort study.

Background: Treatment with antitumor necrosis factor alpha (anti-TNF-α) is safe and effective as first-line therapy; however, its efficacy is limited due to primary nonresponse (PNR) and secondary loss of response (LOR), resulting in treatment discontinuation in approximately 40%-50% of cases. Vedolizumab (VDZ) and ustekinumab (UST) therapies could be good alternatives in patient with anti-TNF failure; however, no head-to-head randomized comparison of these drugs as second- or third-line treatments has been made. Objectives: This study aimed to assess the treatment persistence and comparative effectiveness of UST and VDZ in patients with refractory Crohn's disease (CD). Design: In this nationwide retrospective study, patients with CD on UST or VDZ maintenance therapy were enrolled. Clinical data at baseline, after induction, and at week 52 were obtained. Methods: Clinical and biochemical activities as well as corticosteroid-free remission (SFR) rates were assessed, while concomitant medications, comorbidities, hospitalizations, and surgeries were recorded during the follow-up to detect any predictors. Results: A total of 161 UST- and 65 VDZ-treated patients completed the follow-up. No significant difference in clinical or biochemical remission rates was observed after induction between the two treatment groups; however, clinical remission rate at week 52 was higher in UST group. UST showed superior drug persistence than VDZ (86.5%, 57.9%, p < 0.0001). The drug type was predictive of clinical SFR at week 52 [p = 0.011, odds ratio (OR) = 2.39 with UST]. Drug failure rates were higher for VDZ than those for UST (PNR rates: 21.54% and 4.97%, respectively, p < 0.001, OR = 8.267, p = 0.001). LOR and escalations were more common during UST treatment (61.5% versus 36.9%, p < 0.001; 64.2% versus 23.1%, p < 0.001). Hospital and surgical admission rates did not differ significantly. Only one adverse event occurred with VDZ at week 20, which led to drug cessation. Conclusions: VDZ and UST were safe and effective for treating patients with CD in whom anti-TNF therapy failed. UST showed superior drug persistence than VDZ, but dose escalation was more frequent. Biologicals used in lower treatment lines resulted in better drug persistence.