Clinical Case Summary

Introduction: This case describes a rare complication, triggered by SARS-CoV2 infection in a patient with Crohn’s disease (CD) and a long history of gastrointestinal and extraintestinal manifestations but otherwise stable at the infection onset.
Case Presentation: 25-year old male,non smoker, unvaccinated against COVID-19,with fistulizing and stricturing CD diagnosed at age 12 with multiple extraintestinal complications (articular,ocular, thrombotic, malnutrition). Therapeutic history is marked of various failed attempts over the years, ranging from many courses of steroids, anti-TNFalfa drugs, immunosupresives to holistic approaches until the age of 24 when he presented at our clinic and we initiated treatment with ustekinumab with a good response. During his previous visit,he presented with fever and COVID-19 infection. Radiologic image of the lung was normal but a computed tomography scan was performed to rule out a complication of CD. Both clinical and imaging evaluations confirmed a stable condition with colo-cutaneous fistula in partial remission. Four days later he presented with signs of acute abdomen, extremely distressed, hypotensive,tachycardic.
Tests revealed: leukocytosis, rised inflammatory markers, thrombocytopenia, high D-dimer. The scan suggested a perforation and was taken to surgery where the laparotomy confirmed it, at the level of the transverse colon. He suffered a cardiopulmonary arrest during the surgery and died despite resuscitative efforts.
Discussion: SARS-CoV2 virus binds to the human angiotensin-converting enzyme 2 receptors and triggers direct endothelial lesions and activation of prothrombotic factors resulting in a cascade of microvascular injury and ultimately ischemic tissue damage. Ischemia weakens the bowel wall, increasing risk of ulceration, necrosis,and perforation, especially in Crohn’s patients with fragile mucosa.
Conclusion: The case highlights the potential for fatal outcomes and the importance of close observation in CD patients during SARS CoV2 infection.

References

Images with the colo-cutaneous fistula before and after the treatment with ustekinumab
Ragiologic and computed tomography imaging from his previous visit with the first SARS-CoV2 positive test
Radiologic and computed tomography imaging from his last visit when he presented with acute abdomen

Introduction

Post endoscopy upper gastrointestinal cancers (PEUGIC) are often missed opportunities to diagnose earlier or even prevent cancer. Up to 71% of PEUGIC are potentially avoidable, but identifying and investigating them can be challenging. A national process for identifying all PEUGIC in the English National Health Service and performing root cause analysis was developed.

Aims & Methods

Potential PEUGIC between 2017 and 2023 occurring 3-36 months after an index endoscopy which did not result in a cancer diagnosis were identified from National Cancer Registration Dataset and Hospital Episode Statistics held by the National Cancer Registration and Analysis Service. Data from local root cause analysis were uploaded onto a secure portal for national analysis. PEUGIC following surveillance endoscopies were excluded from this analysis. Logistic regression analysis was used to identify associations with outcomes of interest.

Results

3151 potential PEUGIC were examined by local reviewers in 144 English hospitals. 635 (20%) were excluded on local review and data were available for 2516 PEUGIC. 1897 (75.4%) PEUGIC followed diagnostic, follow-up or screening endoscopies. PEUGIC sites were oesophagus 61%, stomach 34% and duodenum 5%.
Table 1 shows the summary PEUGIC root cause results analysis based on the World Endoscopy Organisation categorisation. Categories C and D were associated with poor outcomes with 29% and 23% of cases receiving curative treatment, respectively. Compared to categories A and B receiving curative treatment in 53% and 37% of cases, respectively. Squamous cell cancers accounted for 37.5% of oesophageal PEUGIC and were associated with no lesion being detected (category C or D) in the PEUGIC segment OR 1.71 (95% CI 1.21-2.43).
Findings on index endoscopy (category A or B) at later oesophageal PEUGIC: pre-malignant lesion 23% (e.g. Barrett’s), cancer associated lesion 20% (e.g. ulcer) and other oesophageal focal lesions 15%. Findings on index endoscopy in gastric PEUGIC: cancer associated lesion 26%, pre-malignant lesion 7% and other gastric focal lesions 18%. 45% of the index endoscopies were classified as inadequate. Patient harm and adverse treatment outcomes were associated with an inadequate index endoscopy OR 1.56 (95% CI 1.28-1.91). The most common reason for inadequate endoscopy was inadequate management of lesions identified, which were most likely to be cancer associated lesions OR 1.43 (95% CI 1.11-1.69), specifically oesophageal strictures (24%) and gastric ulcers (23%).
Gastric diagnostic PEUGIC were diagnosed with more advanced cancer (40% stage 4 at diagnosis vs 30% oesophageal PEUGIC). Treatment following cancer diagnosis was adversely affected in 42% of PEUGIC. Reviewers considered that 57% of PEUGIC were at least possibly avoidable and 9% led to premature death.

Table 1 Root causes of all diagnostic PEUGIC

PEUGIC categorisation	Completed cases
A: Lesion detected, adequate assessment and decision making but PEUGIC occurred	595 (31%)
B: Lesion detected, inadequate assessment and decision making	522 (28%)
C: Possible missed lesion, endoscopy and decision making adequate	464 (24%)
D: Possible missed lesion, endoscopy and decision making inadequate	315 (17%)

Conclusion

Abnormalities in the area of the later cancer were detected at index endoscopy in 59% of PEUGIC. Inadequate lesion assessment, endoscopy and/or decision making was noted in 45% of PEUGIC, which adversely affected treatment outcome. Oesophageal squamous cell cancer was a common cause of PEUGIC, suggesting issues with lesion recognition in this cancer. Many patients had incurable disease when diagnosed and treatment was adversely affected in 42%.

Introduction

Colorectal cancer (CRC) is the most common cancer in Spain, with an estimated 44,573 new cases in 2025. The standard CRC screening strategy involves the immunological faecal occult blood test (FIT), followed by colonoscopy in positive cases. However, the low specificity of FIT results in a significant number of unnecessary colonoscopies, placing a high burden on healthcare systems. There is a growing need to explore alternative screening strategies that offer better cost-effectiveness ratios. The gut microbiota plays a key role in CRC carcinogenesis, and several bacterial species involved in this process have been identified. A diagnostic tool based on the combination of FIT (cut-off 100 ng/mL – FIT100) and a bacterial signature has been designed to detect CRC and advanced lesions (AL, defined as ≥1 cm and/or high-grade dysplasia and/or a hairy component). This tool uses qPCR to analyse the relative abundance of specific bacteria in the same stool sample used for FIT testing. Previous studies, including a proof-of-concept (N=172), confirmatory study (N=327), and clinical performance study (N=2,481), have validated the tool.

Aims & Methods

This study aims to evaluate the diagnostic performance of the bacterial signature applied to FIT100 positive participants and its potential to reduce unnecessary colonoscopies in the CRC screening program in Catalonia.
A prospective observational study was conducted in a multicentre cohort across five hospitals, including participants from the CRC screening program with a positive FIT100. Blinding was applied to the FIT, bacterial signature, colonoscopy, and biopsy. Colonoscopy-biopsy was used as the reference standard. The study included 1,453 participants, of which 48 were excluded from the analysis mainly because of poor sample conditions, resulting in a final sample of 1,405 participants. Sensitivity was defined as the proportion of true positives detected by the FIT that the bacterial signature also identifies as positive. Specificity was defined as the proportion of false positives of FIT that the bacterial signature correctly identifies as true negatives.

Results

From the 1,405 analysed cases, 44 were CRC, 472 AL, and 889 without AL. For CRC detection, the sensitivity was 95.5%, with a specificity of 18.4%. The reduction in false positives was 18.4%. For AL and CRC combined, the sensitivity was 82.6%, with a specificity of 18.4%.

Conclusion

The bacterial signature applied to FIT100 positive participants demonstrates high sensitivity for CRC detection while reducing unnecessary colonoscopies by minimizing false positives. Its implementation in the CRC screening protocol could improve the overall efficiency of the screening process. Future studies should focus on cost minimization and assess the tool's cost-effectiveness to ensure a favourable risk-benefit ratio for broader implementation.

Introduction

Gastrointestinal (GI) hemorrhage accounts for 30% of acute decompensations in cirrhotic patients, with 60% originating from variceal bleeding. Each decompensation episode carries an in-hospital mortality rate of 13%, and a 6-week mortality rate of 20%, commonly assed using Child Pugh (CP) and MELD scores. The ALBI (Albumin-Bilirubin) score, which includes only two variables, offers a simplified evaluation of liver function. However, there is limited data on its utility in predicting short-term mortality in cirrhotic patients with GI hemorrhage.

Aims & Methods

This study aimed to evaluate the association between ALBI Score with short-term mortality in cirrhotic patients with GI hemorrhage. We conducted a prospective, cross-sectional study between January and December of 2023 at Hospital Roosevelt, Guatemala, including cirrhotic patients admitted for GI hemorrhage. Informed consent was obtained from all participants. Categorical variables were analyzed using the chi-square test, normally distributed continuous variables with Student’s t-test, and non-normally distributed variables with the Mann-Whitney U test. Logistic binary regression and AUROC analysis were used to assess associations with short-term mortality. Statistical analyses were performed using SPSS.

Results

A total of 187 patients were included: 50.8% female and 49.2% male, with a mean age of 56 among survivors and 58 among non-survivors. Of these, 52.9% had a prior diagnosis of cirrhosis, while 47.1% were newly diagnosed. Cirrhosis etiology was metabolic in 50.2%, alcoholic in 42.7%, autoimmune in 4.3%, HCV in 1.6%, and HBV in 1.1%. At admission, 80.8% had no ascites and 97.3% had no hepatic encephalopathy. he causes of GI hemorrhage were 86.1% esophageal varices, 3.2% gastric varices, 9.1% gastric ulcers, and 1.6% esophagitis.
Non-survivors had significantly lower systolic blood pressure (93.90 ± 16.3 mmHg vs. 107.92 ± 17.4 mmHg; p = 0.002) and mean arterial pressure (69.50 ± 14.5 mmHg vs. 79.67 ± 11.7 mmHg; p = 0.005) compared to survivors. Non-survivors exhibited significantly higher INR (1.79 ± 0.56 vs. 1.52 ± 0.41; p = 0.026) and total bilirubin (5.85 ± 8.73 mg/dL vs. 2.02 ± 2.82 mg/dL; p = 0.031), and lower serum albumin levels (2.40 ± 0.43 g/dL vs. 3.10 ± 0.54 g/dL; p < 0.001).

Prognostic scores were significantly higher among non-survivors: MELD (19.25 ± 10.09 vs. 13.57 ± 5.47; p = 0.002), MELD-Na (20.35 ± 9.76 vs. 14.44 ± 6.42; p = 0.002), Child-Pugh (9.15 ± 2.21 vs. 7.18 ± 1.90; p < 0.001), and ALBI score (-0.96 ± 0.51 vs. -1.76 ± 0.58; p < 0.001). Additionally, the length of hospital stay was significantly shorter among non-survivors (3.90 ± 3.82 days) compared to survivors (6.59 ± 5.58 days; p = 0.001).

Scores	Mortality In-Hospital	Mortality at 4 weeks	Mortality at 6 weeks
ALBI	AUC: 0.850 95% CI (0.780 - 0.921) p: 0.000	AUC: 0.881 95% CI (0.823 - 0.938) p: 0.000	AUC: 0.867 95% CI (0.806 - 0.927) p: 0.000
Child Pugh (CP)	AUC: 0.762 95% CI (0.668 - 0.857) p: 0.000	AUC: 0.819 95% CI (0.739 - 0.900) p: 0.000	AUC: 0.805 95% CI (0.728 - 0.881) p: 0.000
MELD	AUC: 0.714 95% CI (0.606 - 0.822) p: 0.002	AUC: 0.785 95% CI (0.693 - 0.878) p: 0.000	AUC: 0.786 95% CI (0.700 - 0.871) p: 0.000
MELD-Na	AUC: 0.711 95% CI (0.599 - 0.823) p: 0.002	AUC: 0.778 95% CI (0.683 - 0.873) p: 0.000	AUC: 0.783 95% CI (0.696 - 0.870) p: 0.000

Multivariable analysis showed that:

• Higher ALBI score was significantly associated with mortality (Risk Ratio 25.80; 95% CI: 6.75–98.67; p < 0.001),
• Hospital stay <5 days (RR 9.91; 95% CI: 2.07–47.47; p = 0.004),
• Endoscopy performed within 12 hours (RR 7.53; 95% CI: 2.01–28.15; p = 0.003).

Conclusion

The ALBI score outperforms CP and MELD scores in predicting short-term mortality (in-hospital, 4 weeks, and 6 weeks) in cirrhotic patients with GI hemorrhage. Observed mortality was 10% in-hospital, 13% at 4 weeks, and 16% at 6 weeks.

Introduction

Delayed bleeding after gastric endoscopic submucosal dissection (ESD) is a serious complication in older adults. The BEST-J score, developed by Hatta et al. (Gut, 2021), is widely used for bleeding risk stratification but does not reflect systemic factors. The Prognostic Nutritional Index (PNI), calculated as [10 × serum albumin (g/dL)] + [0.005 × total lymphocyte count (/μL)], may complement this score. This study evaluated whether combining PNI with the BEST-J score improves risk stratification.

Aims & Methods

We retrospectively analyzed 252 patients who underwent gastric ESD between April 2016 and February 2025, including 127 older (≥75 years) and 125 younger (<75 years) individuals. Patients were classified into low (<40) and high (≥40) PNI groups. The association between delayed bleeding, PNI, and BEST-J score was analyzed using receiver operating characteristic (ROC) analysis. To evaluate internal validity, we conducted 5-fold cross-validation of a logistic regression model that added 1 point for PNI < 40 to the BEST-J score. A cutoff value of PNI < 40 was used, based on previously reported clinical thresholds reflecting impaired nutritional and immune status, including its predictive value for bleeding in various clinical settings (Zhao et al., 2024; Lin et al., 2021).

Results

The delayed bleeding rate was 4.7% in the older group and 0.8% in the younger group. Mean PNI was lower in bleeding cases (44.7) than in non-bleeding cases (48.5). Among older adults, the AUCs for PNI and BEST-J alone were 0.65 and 0.72, respectively. Adding 1 point for PNI < 40 improved the AUC to 0.82. Cross-validation confirmed good model reproducibility, with a mean AUC of 0.861 and standard deviation of 0.147, indicating stable predictive performance without overfitting. The inclusion of PNI < 40 enhanced model sensitivity for identifying bleeding cases without substantially compromising specificity, improving clinical applicability. These associations were most prominent in older patients, supporting age-specific application of the combined model.

Conclusion

The combination of BEST-J and PNI provides an improved and practical approach to risk stratification for delayed bleeding after gastric ESD in older adults. Cross-validation supports the model's internal validity and suggests applicability to broader clinical populations. Given the disproportionately higher bleeding risk in the older cohort, our findings underscore the importance of incorporating host-related factors such as nutrition into stratification strategies specifically in this age group.

References

1. Hatta W, Tsuji Y, Yoshio T, et al. Prediction model of bleeding after endoscopic submucosal dissection for early gastric cancer: BEST-J score. Gut. 2021;70(3):476–484. doi:10.1136/gutjnl-2019-319926.
2. Zhao Y, Chen X, Zhang M, et al. Association of Prognostic Nutritional Index with Post-Discharge Bleeding in Acute Coronary Syndrome Patients on Dual Antiplatelet Therapy. Front Cardiovasc Med. 2024;11:11995920.
3. Lin Y, Wang J, Chen Z, et al. Preoperative Prognostic Nutritional Index Predicts Intraoperative Transfusion and Surgical Outcomes in Hepatocellular Carcinoma Patients Undergoing Hepatectomy. Cancers (Basel). 2021;13(11):2508.

Introduction

Screening programmes for gastric cancer are currently being researched in Europe as part of the TOwards GAstric Cancer Screening Implementation (TOGAS) project (1). A ‘screen & treat’ approach for Helicobacter pylori (H. pylori), is one such strategy being assessed as part of a primary preventative measure. In order for such a programme to be viable, the availability of an effective treatment is paramount. Given the rising rates of antimicrobial resistance worldwide, careful consideration must be given to prescribing first-line treatment with the highest efficacy. This interim report evaluates key performance measures in the treatment of H. pylori within the Irish arm – representing the Western European cohort - of the TOGAS pilot screening programme.

Aims & Methods

This interim data evaluates the efficacy of 10-day treatment with single capsule combination therapy: Bismuth subcitrate 140mg/Metronidazole 125mg/Tetracycline 125mg, three tablets, four times daily (PYLERA, Juvise pharmaceuticals) with a high-dose proton pump inhibitor (Esomeprazole 40mg twice daily).
Secondary outcome measures include;

1. Treatment acceptance rate
2. Side-effect profile
3. Adverse events

3030 individuals aged 30-34 years were invited to undergo screening for H. pylori through their general practitioner or workplace in the period January 24-March 25. Those who tested positive on both serology (BIOHIT H. pylori IgG antibody) and 13-C urea breath test (IR Force 200, Richen Medical) were offered treatment. Treatment consisted of 10-day combination therapy (PYLERA) and a high-dose proton pump inhibitor (PPI). Eradication confirmation with a 13-C UBT was offered a minimum of 6 weeks post-treatment. Demographics, risk factors for infection, treatment effectiveness and side effect profile were recorded. Stata was used for statistical analysis. χ² test was used for comparison of categorical variables (significance level p<0.05).

Results

464 asymptomatic individuals were enrolled. The median age was 32; 48%(n=223) were male. 11%(n=50) tested positive on both serology and 13-C UBT. Those who tested positive were more likely to be male [64%] (p < 0.02), a history of current or previous smoking was found to be nonsignificant (34%, p <0.9). 96%(n=48) of positive participants consented to treatment; 2 were excluded from receiving treatment due to pregnancy. Among those treated, 96% (44/46) reported adherence rates of >90%. In those reporting compliance rates <90 %, side effect profile was the leading cause of non-compliance. Side effects were reported by 24% (11/46) of participants. These were predominantly gastrointestinal side effects and reported as mild-moderate in severity, 6% discontinued treatment on account of them (n=3). All symptoms resolved after cessation. No serious adverse events occurred. Post-treatment, a 13-C UBT was completed in 80% (n=37) of treated individuals. Eradication rates were 97% (36/37) in the per-protocol group and 89% (33/37) in the intention-to-treat group. Treatment discontinuation due to side effects was the leading cause of treatment ‘failure’. In those requiring 2^nd line therapy (n=4), levofloxacin-based quadruple therapy was found to be successful in 66%(2/3) of those who completed eradication follow-up.

Conclusion

Single capsule combination therapy and high-dose PPI achieved eradication rates of >90% in the per-protocol group. No serious adverse events occurred secondary to treatment. These interim results indicate that 10-day combination therapy serves as an effective first-line therapy for future population-based screening programmes in a European population.

References

1. Commission E. TOGAS - Towards Gastric Cancer Screening Implementation in the European Union: European Commission; 2023 [Available from: https://health.ec.europa.eu/non-communicable-diseases/cancer/europes-beating-cancer-plan-eu4health-financed-projects/projects/togas_en.

Disclosure

Dr. Deane reports receipt of research funding support from EU4 Health grant GA number: 101101252. Juvise pharmaceuticals provided PYLERA for this branch of the study.

Introduction

No clinical trial has previously assessed the best therapeutic strategy between switching to another anti-TNF or swapping to another class of biologic class after the failure of a first anti-TNF in ulcerative colitis (UC). The aim of the EFFICACI trial was to compare the efficacy of vedolizumab to infliximab in patients who had failed a first sub-cutaneous anti-TNF (golimumab and/or adalimumab).

Aims & Methods

EFFICACI was a French double-blind multicenter randomized controlled trial (1:1) comparing intravenous vedolizumab 300 mg at weeks 0-2-6 to intravenous infliximab 5 mg/kg at weeks 0-2-6. Eligible patients had moderate-to-severe UC, defined by a total Mayo score ≥ 6 with an endoscopy subscore ≥ 2, despite at least 12 weeks (W) of treatment with adalimumab or golimumab as first line of advanced therapy. The primary endpoint was steroid free clinical remission at W14 (total Mayo score ≤2 without subscore >1 including an endoscopic subscore ≤ 1). Clinical response was defined as a decrease in partial Mayo score ≥3 points and ≥30% from inclusion and a decrease in rectal bleeding score ≥1. The number of patients (N=150) was estimated for a 20% difference in favor of vedolizumab with a type 1 risk of 5% and a power of 80%. Patients were subsequently followed in an open-label fashion until week 54. The analysis was performed on an intention-to-treat basis. Only results at W14 will be presented. (CPP: 2018-002673-21; ClinicalTrial: 35RC17_8841_EFFICACI)

Results

From January 2018 to December 2023, 151 patients were randomized among 19 centers: 78 in the vedolizumab arm and 73 in the infliximab arm. One patient randomized to the infliximab arm did not receive treatment and considered as failure regarding the ITT analysis. Characteristics and demographics at inclusion were similar between groups, with 102/151 (67.5%) patients failing adalimumab and 49/151 (32.5%) failing golimumab. Concomitant immunosuppressive treatment with thiopurine or methotrexate was associated with infliximab and vedolizumab for 37/72 (51.4%) patients and 43/78 (55.1%) patients, respectively. At W14, proportions of patients in clinical remission (primary endpoint) were 34.6% (27/78) with vedolizumab and 19.2% (14/73) with infliximab (p=0.033). The clinical response rates were 46/78 (59.0%) with vedolizumab and 36/72 (50.0%) with infliximab (p=0.27). Proportions of patients in clinical response at W2, W6 and W14 are shown in Figure 1. At W14, endoscopic improvement (Mayo endoscopic subscore 0 or 1) was observed in 36/77 (46.8%) patients in the vedolizumab arm and 21/72 (29.2%) in the infliximab arm (p=0.027). No factor at inclusion was predictive of remission at week 14, including pharmacokinetic data for the first-line anti-TNF. Adverse event rates were similar in both groups - 46 (63.9%) infliximab arm, 55/78 (70.51%) vedolizumab arm. Before week 14, a colectomy was indicated in one patient in the vedolizumab arm; eight patients were hospitalized for a severe flare (5 in the infliximab arm and 3 in the vedolizumab arm). At W54, proportions of patients in clinical remission and still treated with the treatment allocated after randomization were 34 (46.6%) with vedolizumab and 25 (36.2%) with infliximab (p=0.21). Data at W54 are still under investigation at the time of abstract submission.

Conclusion

After failure of a first subcutaneous anti-TNF, induction therapy with vedolizumab was superior to infliximab in achieving steroid free clinical remission at week 14 in patients with UC.

Disclosure

National grant by the French PHRC, grant from takeda