Introduction

Endoscopic radical excision in the rectum may offer a curative, organ-preserving strategy, potentially reducing the need for surgery and its associated morbidity and mortality.¹ The muscle-retracting sign (MRS) detected using the pocket-detection method (PDM) has shown moderate to high diagnostic accuracy for real-time submucosal invasion (SMI) depth assessment in rectal lesions.² This study evaluated the technical and clinical outcomes of a structured algorithm combining PDM and MRS for real-time invasion depth assessment with endoscopic resection of rectal lesions.

Aims & Methods

We prospectively included consecutive patients with rectal lesions at risk of SMI at a tertiary care centre between September 2023 and March 2025. We excluded lesions with nodal metastases on radiological staging and subepithelial lesions. A management algorithm was applied, incorporating PDM for MRS status evaluation and invasion assessment, followed by endoscopic resection based on MRS status, lesion size, and location: endoscopic submucosal dissection (ESD; MRS-, all locations), endoscopic intermuscular dissection (EID; MRS+ or severe fibrosis, distal rectum), knife-assisted full-thickness resection (kFTR; MRS+ or severe fibrosis, any size, proximal extraperitoneal rectum), or device-assisted full-thickness resection (FTRD; MRS+ or severe fibrosis, ≤15 mm, intraperitoneal rectum). Primary outcomes were technical success, en-bloc and R0 resection and adverse events.

Results

37 rectal lesions were included (mean patient age 68.8 years [SD 10.1]; 56.8% male). The median lesion size was 30 mm (IQR 20–40), mostly located in the distal rectum (23/37; 62.2%), and distributed as anterior (n = 12), lateral (n = 11), and posterior (n = 14). 5 lesions (13.5%) were classified as JNET 2b, 15 (40.5%) as JNET 3.
Among MRS-negative lesions (23/37; 62.2%), 22 underwent ESD, and 1 underwent EID for submucosal fibrosis. In MRS-positive lesions (14/37; 37.8%), the selected treatments included EID in 7, kFTR in 6, and FTRD in 1.
Technical success of PDM and endoscopic resection was achieved in 36/37 cases (97.3%). En-bloc resection was achieved in 36/37 (97.3%) cases, and R0 resection in 34/36 (94.4 %). Pathology revealed deeply invasive (>pT1sm1) adenocarcinoma in 14/37 (37.8%), with 83.8% diagnostic accuracy of PDM + MRS. Curative resection was achieved in 26/37 cases (70.3%). Adverse events occurred in 4/37 patients (10.8%), including delayed bleeding in 3 (8.1%) and pneumonia in 1 (2.7%). No delayed perforation occurred. The median length of hospital stay was 1 day (IQR 1-1).
Rectal preservation was achieved in 34/37 patients (91.9%), with a median follow-up of 8.8 months (IQR 5.3-10.8). We observed no loco-regional recurrences, distant metastases, or deaths. Surgery was performed for technical failure in one case (kFTR aborted due to massive invasion, pT2N0 adenocarcinoma) and for non-curative resections in 2 cases (one with pT0N1 and another with pT0N0 in surgical specimens).

Conclusion

The PRIME endoscopic algorithm demonstrated high technical success, en-bloc and R0 resection rates for rectal lesions at risk of SMI. This minimally invasive approach allowed rectal preservation in the majority of patients with a low rate of complications, making it a promising alternative to surgery for such lesions.

References

1. Argenziano, M.E.*, Sorge, A.*, Hoorens, A., Montori, M., Poortmans, P.J., Smeets, S., Tornai, T., Debels, L.K., Desomer, L. and Tate, D.J. (2025), Knife-assisted full-thickness resection guided by the pocket-detection method for posterior deeply invasive rectal cancer: A novel endoscopic approach (with video). DEN Open, 5: e70116. https://doi.org/10.1002/deo2.70116
2. Argenziano, M E*; Sorge, A*; Montori, M; Poortmans, P J; Tornai, T; Smeets, S; Al-Dury, S; Debels, L; Desomer, L; Tate, D J Accuracy of the Muscle Retraction Sign for determining deep Submucosal Invasion During Endoscopic Resection of Rectal Lesions. Endoscopy 2025; 57(S02): 14 - 14 DOI: 10.1055/s-0045-1805114

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

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

Helicobacter pylori (Hp) infection is highly prevalent in Portugal, affecting over 60% of the population. Antibiotic resistance poses a significant challenge to Hp treatment; however, empirical regimens remain the standard of care over susceptibility-guided approaches. This study aims to evaluate the most recommended therapeutic options for Hp eradication and to identify risk factors associated with treatment failure.

Aims & Methods

Prospective cohort study conducted in a single centre, including all patients treated for Hp infection between 2013 and 2024. We analysed four eradication regimens: triple therapy (Tri), bismuth quadruple therapy (QuadB), concomitant quadruple therapy (QuadC) and sequential quadruple therapy (QuadS). We collected data on patient demographics and clinical characteristics and compared adherence rates, treatment effectiveness and incidence of adverse events.

Results

Included 591 patients, with a median age of 57 years (IQR 47-66) and female sex 57.2%. The main indication for Hp testing was dyspeptic symptoms (61.1%). The prescribed therapeutic regimens were QuadC in 34.0% of patients, QuadB in 32.8%, Tri in 23.2% and QuadS in 10.0%. According to the intention-to-treat analysis, QuadC (92.9%) and QuadB (90.4%) showed significantly higher eradication rates compared with Tri (73.9%, p<0.001), with no difference observed for QuadS (84.2%, p=0.30 vs QuadC; p=0.61 vs QuadB). Adverse events were significantly less frequent with Tri (0.06%) and QuadS (0.02%) compared to QuadC (0.18%, p<0.01) and QuadB (0.17%, p<0.05), but overall adherence to treatment was 97.1%, with no significant difference among regimens (p=0.19). Logistic regression identified predictive factors for treatment failure: prior eradication attempts (OR 2.31; 95% CI 0.3-1.4), poor adherence (OR 14.5; 95% CI 0.7-4.7) and absence of statin use (OR 2.33; 95% CI 0.07-1.6), with an AUC of 0.72.

Conclusion

QuadC and QuadB therapies are more effective for Hp eradication but are associated with increased rates of adverse events, without a negative impact on overall treatment adherence. Therapeutic failure is more likely in non-naive patients, those with poor adherence to treatment and without statin use.

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).

• 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.