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Introduction

The American Gastroenterological Association has recommended metformin as chemopreventive agent for colorectal cancer (CRC).

Aims & Methods

We aimed to compare sodium-glucose cotransporter-2 inhibitors (SGLT-2i) (either as monotherapy or combination therapy with metformin) to metformin monotherapy on CRC risk in type 2 diabetes (T2D) patients.
Using the territory-wide electronic healthcare database in Hong Kong, we identified all adults with T2D aged >=18 years initially receiving SGLT-2i or metformin between January 2015 and June 2022. Index date was defined as the first date of study medication prescription and a 180-day lead-in period was used to categorize patients into SGLT-2i(+)/metformin(-), SGLT-2i(+)/metformin(+), and SGLT-2i(-)/metformin(+) groups. Primary outcome was CRC development. Secondary outcomes were (i) CRC-related mortality, (ii) colonic adenoma (any, non-advanced and advanced) development. Advanced adenoma was defined as adenoma with villous histology or high-grade dysplasia. Overlap weighting was applied to balance baseline characteristics, including age, sex, body mass index, smoking, alcohol, hemoglobin A1c, T2D duration, comorbidities (dyslipidemia, hypertension, stroke, heart failure, coronary artery disease, atrial fibrillation), prior colonoscopy, other anti-diabetic medications, aspirin, and statins. The intention-to-treat design was applied, and multivariable Cox regression models were conducted to estimate adjusted hazard ratios (aHRs) of outcomes with SGTL-2i use. Dose-response relationship was investigated according to defined daily dose (DDD), with one DDD being equivalent to daily use of dapagliflozin 10 mg, canagliflozin 200 mg, empagliflozin 17.5 mg, or ertugliflozin 10 mg. Duration-response relationship was investigated according to the proportion of SGLT-2i use, derived by dividing the treatment duration by follow-up duration.

Results

Among 436,890 T2D patients (mean [SD] age: 64.3 [11.6] years; 48.7% male), there were 8,481 (1.9%) SGLT-2i(+)/metformin(-), 48,008 (11.0%) SGLT-2i(+)/metformin(+), and 380,401 (87.1%) SGLT-2i(-)/metformin(+) users. During a median follow-up of 6.3 years [interquartile range: 3.2–7.8], there were 4,976 (1.1%) incident CRC cases and 1,311 (0.3%) CRC-related deaths. When compared with SGLT-2i(-)/metformin(+), both SGLT-2i(+)/metformin(+) and SGLT-2i(+)/metformin(-) were associated with a lower CRC risk (aHR:0.51, 95%CI:0.0.36-0.73; and aHR:0.46, 95%CI:0.25-0.86, respectively). There was no difference in CRC risk between SGLT-2i(+)/metformin(+) and SGLT-2i(+)/metformin(-) (aHR:1.11, 95%CI:0.54-2.26). When metformin was used as the reference group, a stepwise decreasing risk of CRC was observed for SGLT-2i 0.5-0.9 DDD (aHR:0.76, 95%CI:0.64-0.90) and 1 DDD or above (aHR:0.46, 95%CI:0.35-0.60) (P_trend<0.001). Similarly, a duration-response relationship existed – SGLT-2i use proportion <80% with aHR:0.73 (95%CI:0.57-0.94) and >=80% with aHR:0.62 (95%CI:0.52-0.74) (P_trend<0.001). In addition, SGLT-2i was associated with lower risk of CRC-related mortality (aHR:0.45, 95%CI:0.29-0.68), any adenoma (aHR:0.81, 95%CI:0.75-0.88), non-advanced adenoma (aHR:0.84, 95% CI:0.77-0.91) and advanced adenoma (aHR:0.59, 95%CI:0.48-0.72) than metformin monotherapy.

Conclusion

SGLT-2i, either as monotherapy or combination therapy with metformin, associated with lower risk of CRC than metformin monotherapy, in a dose- and duration-response manner. Randomized clinical trials investigating effect of SGLT-2i on colonic polyp are warranted to validate our study findings.

SODIUM-GLUCOSE COTRANSPORTER-2 INHIBITORS WERE ASSOCIATED WITH LOWER RISK OF COLORECTAL CANCER AND ADENOMA THAN METFORMIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS

Ka Shing Cheung 1, Xianhua Mao 2, Jing Tong Tan 2, Wai Keung Leung 2, Wai-Kay Seto 1

1 The University of Hong Kong, Hong Kong, Hong Kong|||The University of Hong Kong-Shenzhen Hospital, Shenzhen, China

2 The University of Hong Kong, Hong Kong, Hong Kong

Conference

UEG Week Vienna 2024

Topics

Colorectal

Submission format

Abstract

Session

Towards the cure of CRC (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Management of IBD following a cancer diagnosis

Lulia Al-Hillawi 1

1 John Radcliffe Hospital, Oxford, United Kingdom

Event

UEG Postgraduate Teaching Programme Berlin 2025

Topics

Digestive Oncology IBD

Session

Cancer and IBD: Mitigating risk among uncertainty

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Summary: Cancer and IBD - Mitigating risk among uncertainty

Michael Schumann 1

1 Charité Berlin, Berlin, Germany

Event

UEG Postgraduate Teaching Programme Berlin 2025

Topics

Digestive Oncology IBD

Session

Cancer and IBD: Mitigating risk among uncertainty

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Introduction

Crohn's disease (CD) is a heterogeneous condition with potentially complicated course. We aimed to evaluate the rates and risk factors for complicated disease course within a real-world, prospective inception cohort of patients with newly diagnosed CD (ndCD).

Aims & Methods

This prospective, longitudinal cohort study included adults with ndCD managed at a tertiary referral center. Treatment decisions were made at the discretion of the treating physician. The key outcomes were: (1) complicated-disease course - defined as CD-related hospitalization, surgery, steroid dependency, or the use of ≥2 biologics; (2) extra-complicated disease course - defined as recurrent or prolonged hospitalization (>5 days), multiple perianal procedures, intestinal resection, steroid dependency, or the use of ≥3 biologics; and (3) phenotype progression. Kaplan-Meier survival analysis was used to assess rates of complicated course over 5 years, and multivariable Cox regression models were applied to identify baseline risk factors.

Results

A total of 192 patients with ndCD were enrolled; 70% presented with an inflammatory phenotype (B1) (see Table 1). Overall, 150 patients (78.1%) were recommended to start biologic therapy, with half receiving this recommendation within 4.1 months (95% CI: 2.1-6.3) from diagnosis. Of these, 134 patients (89.3%) initiated treatment - 50% within 6 months and 63.6% within 12 months. Cumulative outcome rates at 1, 3, and 5 years post-diagnosis were: complicated course - 24.2%, 35.9%, and 51.3%, respectively; extra-complicated course - 15.6%, 20.5%, and 29.0%, respectively; phenotype progression - 1.6%, 5.5%, and 10.6%, respectively. In a multivariable analysis, patients with a progressive phenotype (B2/B3) at diagnosis had significantly increased risk for complicated (HR 3.3, 95% CI:2.0-5.7) and extra-complicated (HR 6.7, 95% CI:3.1-14.4) disease course. Additional risk factors included elevated inflammatory markers and disease extent at diagnosis. We further analysed the subgroup of 33 patients with a B1 phenotype (~25% of those with a B1 phenotype) who were not recommended biologic therapy by their treating physician. In this subgroup, the complicated course was markedly low, 3.0%, 6.3%, and 11.5% at 1, 3, and 5 years, respectively, and none developed an extra-complicated course. Notably, this subgroup exhibited significantly lower inflammatory indices (CDAI, HBI, CRP, and fecal calprotectin) at diagnosis compared to patients for whom biologics were recommended (all p<0.001).

Table 1:

Sex, Female, n (%)	88 (45.8)
Age, median (IQR)	26 (21-36)
BMI (kg/m2), median (IQR)	21.7 (19.9-25.2)
Never smokers, n (%)	139 (72.4)
Family history of IBD, n (%)	58 (30.2)
Extraintestinal manifestations, n (%)	57 (29.7)
Ileal (L1), n (%) Colonic (L2), n (%) Ileocolonic (L3), n (%)	124 (64.6) 19 (9.9) 49 (25.5)
Perianal (P), n (%)	37 (19.3)
Inflammatory phenotype (B1), n (%) Stricturing phenotype (B2), n (%) Penetrating phenotype (B3), n (%)	137 (71.4) 36 (18.8) 19 (9.9)

Conclusion

In this real-world cohort, applying a best-practice treatment approach, over half of patients with ndCD experienced a complicated course within five years, primarily those with a progressive phenotype at diagnosis. Notably, a subset of patients with an inflammatory phenotype and low inflammatory burden had favorable long-term outcomes without biologics, underscoring the importance of early risk stratification to guide individualized treatment strategies.

COMPLICATED AND EXTRA-COMPLICATED DISEASE COURSE IN NEWLY DIAGNOSED CROHN’S DISEASE: FIVE-YEAR RESULTS FROM A REAL-WORLD PROSPECTIVE INCEPTION COHORT

Tali Sharar Fischler 1, Jacob E. Ollech 1, Idan Goren 2, Hagar Banai Eran 1, Yifat Snir 1, Yelena Broitman 1, Adi Friedeberg 1, Maor Pauker 1, Irit Avni-Biron 1, Iris Dotan 1, Henit Yanai 1

1 Rabin Medical Center, Petah-Tikva, Petah Tikva, Israel|||Tel Aviv University, Tel Aviv, Israel

2 SUNY Upstate Medical University, Syracuse, United States|||Rabin Medical Center, Petah-Tikva, Petah Tikva, Israel

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Real-world evidence of Crohn's disease (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Panel discussion: Cancer and IBD - Mitigating risk among uncertainty

Event

UEG Postgraduate Teaching Programme Berlin 2025

Topics

Digestive Oncology IBD

Session

Cancer and IBD: Mitigating risk among uncertainty

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Introduction

In ulcerative colitis (UC) in clinical remission, Mayo Endoscopic Score (MES)1 results in clinical relapse compared to MES0. Recently, EndoBRAIN-UC, an Artificial Intelligence (AI)-assisted colonoscopy system with contact microscopy capability, has become commercially available. EndoBRAIN-UC predicts Geboes score (GS) ≥ 3.1 as an auxiliary diagnosis and determines the presence of histological inflammation (Active). We aim to evaluate the impact of the presence of histological inflammation (GS ≥ 3.1) on MES1 relapse in real clinical practice using EndoBRAIN-UC.

Aims & Methods

The study will include UC patients with colonoscopically confirmed MES1 during clinical remission (partial Mayo score [PMS] <2 and rectal bleeding score 0), who will undergo AI-assisted diagnosis of MES1 sites and will be compared in the AI-Active (GS≥3.1 equivalent) group and AI-Healing (GS<3.1 equivalent) group in terms of cumulative relapse rate over the following 2 years.
Biopsy was performed at the site of AI-assisted diagnostic decision and histological evaluation was also performed. Histologic remission was defined as GS <3.1, and clinical relapse was defined as PMS ≥2 or intensified treatment for UC (excluding topical treatments only).

Results

Fifty-five patients (29 male [52.7%], median disease duration 15.7 [1.5-40.8] years, median PMS 0 [0-0]) were enrolled: AI-Active group by AI judgment: 36 patients (65.4%), GS≥3.1 by biopsy pathology: 23 patients (41.8%). The AI-Active decision identified GS≥3.1 significantly superior to the AI-Healing decision, with a sensitivity of 82.6%, specificity of 46.9%, positive predictive value of 52.8%, and negative predictive value of 78.9% (p=0.04). No significant difference in cumulative relapse rate was observed in the interim analysis at 1 year between the AI-Active (3/33 patients) and AI-Healing (2/17 patients) groups (Log rank test: p=0.77). On the other hand, there was a trend toward cumulative relapse in GS≥3.1 (4/19) compared with GS<3.1 (1/31) (Log rank test: p=0.06).

Conclusion

The AI-Active decision was able to significantly determine GS≥3.1 and GS<3.1 with a sensitivity of 82.6%, but interim analysis showed that it was difficult to predict relapse in UC patients in clinical remission and with MES1. (UMIN000049858)

PREDICTION OF RELAPSE IN PATIENTS WITH ULCERATIVE COLITIS IN CLINICAL REMISSION AND MAYO ENDOSCOPIC SUB SCORE 1 USING ARTIFICIAL INTELLIGENCE (AI)-ASSISTED DIAGNOSIS OF ULTRA- MAGNIFIED ENDOSCOPY (INTERIM ANALYSIS)

TEPPEI OMORI 1, Miki Koroku 2, Ayumi Ito 2, MARIA YONEZAWA 2, Yousuke Nakai 2

1 Kyorin University Suginami Hospital, Wada, Suginami-ku, Tokyo, Japan|||Tokyo Women's Medical University, Kawada-cho, Shinjyuku-ku, Tokyo, Japan

2 Tokyo Women's Medical University, Kawada-cho, Shinjyuku-ku, Tokyo, Japan

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

IBD (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Introduction

Hyperbaric oxygen therapy (HBOT) is a treatment that delivers 100% oxygen in a pressurized chamber. HBOT enhances tissue oxygenation and neovascularization and proved clinical efficacy in chronic wounds, post-radiation proctitis and enteritis, perianal fistulizing Crohn’s disease, and acute severe ulcerative colitis. Refractory ulcerative colitis (UC) remains a major therapeutic challenge.

Aims & Methods

We evaluated the tolerability, preliminary efficacy, and mechanistic effects including perfusion kinetics measured with intestinal ultrasound (IUS) of 10 and 20 sessions of HBOT in patients with UC. PARADOX was an investigator-initiated, prospective, open label, uncontrolled, dose-finding pilot trial (phase 2a) in biologic-experienced patients with moderate-to-severe, highly refractory UC with a follow-up of 26 weeks (Mayo score >5, MES ≥2, failed ≥2 classes advanced therapies). Patients (n=16; 8 per arm) continued optimized, stable dose background therapy and received 10 or 20 sessions HBOT (2.4 ATA, 120 minutes per day with two 5-minute air breaks). The primary efficacy outcome was predefined composite clinical and endoscopic response (3-point and 30% decrease in Mayo score, RB = 0 and 1-point decrease in MES) at week (W) 12. Other outcomes included tolerability; clinical, symptomatic, endoscopic, and biochemical response, and transmural response assessed by IUS including contrast-enhanced ultrasound (CEUS) to evaluate bowel wall thickness (BWT), vascularity and perfusion kinetics. Endoscopy and IUS were centrally read and adjudicated.

Results

Baseline characteristics were comparable in both cohorts with median age: 48 vs 64 years; disease duration: 12 vs 9 years; ≥4 prior advanced therapies: 3/8 in both; Mayo score: 10.5 vs 9.
At W12, the predefined composite clinical and endoscopic response rate was met in 2/8 patients with 10 sessions and 4/8 patients with 20 sessions. Clinical, endoscopic, symptomatic, biochemical, and IUS parameters all improved over time in both HBOT cohorts with a trend towards larger improvement after 20 compared to 10 sessions (See Table).
At W12, clinical responders demonstrated a significant increase in peak enhancement on CEUS compared to baseline (12.1 dB, 95% CI: 0.8 to 34.3), while non-responders showed a numerical decrease (–5.4 dB, 95% CI: –20.9 to 4.0). This divergent trajectory was consistent across perfusion parameters related to both wash-in and wash-out (e.g., time to peak, wash-in and wash-out rate, area under the curve), suggesting a treatment-related vascular response. In contrast, early gains in non-responders had waned by W12. This effect was numerically larger after 20 sessions, supporting a potential dose–response effect.
HBOT was well tolerated with no dose-limiting toxicities.

Week-12 efficacy results	10 sessions HBOT N = 8	20 sessions HBOT N = 8	(adjusted) Risk Ratio (95% CI)	P-value
Composite clinical and endoscopic response (W12), n (%)	2 (25)	4 (50)	1.7 (0.4 - 4.2)	.31
Clinical remission (W12), n (%)	0	3 (38)	5.2 (0.6 - 49)	.2
Clinical response (W12), n (%)	3 (38)	6 (75)	1.7 (0.4 - 4.2)	.31
Endoscopic improvement (W12), n (%)	0	3 (38)	5.2 (0.6 - 50)	.2
Symptomatic remission (W12), n (%)	4 (50)	4 (50)	0.8 (0.2 - 4.2)	.68
Symptomatic response (W12), n (%)	4 (50)	6 (75)	1.3 (0.4 - 3.9)	.45
Fecal calprotectin at BL, µg/g, mean (95% CI) change from BL-W12, EMM (95 % CI)	1020 (312 - 3370) –631 (–2086 to –194)	735 (223 - 2444) –542 (–1809 to –164)	-	.76
Bowel Wall Thickness of sigmoid (mm) at BL, mean (95% CI) change from BL-W12, EMM (95% CI)	4.2 (2.8 - 5.6) –0.44 (–1.15 to 0.28)	3.9 (2.8 - 5.1) –0.25 (–0.93 to 0.43)	-	.69
Color Doppler Signal of sigmoid, mLimberg ≥2, n (%) at least 1-point improvement from BL-W12, n (%)	2 (25) 3 (38)	4 (50) 3 (38)	1.1 (0.6 – 2.0)	.66

Conclusion

HBOT is a feasible adjunctive therapy in treatment-refractory moderate-severe UC. CEUS showed improved intestinal perfusion in HBOT responders, which offers promising non-invasive tools for response assessment. These findings provide a rationale for a randomized dose-optimized phase 2 trial with potentially longer duration of treatment.