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Trials in upper GI oncology: From efficacy to effectiveness

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Trials in upper GI oncology: From efficacy to effectiveness

Bianca Mostert 1

1 None, None, Netherlands

Event

UEG Week Vienna 2024

Topics

Digestive Oncology Endoscopy Surgery

Session

Quality in upper GI: The good, the bad and the ugly

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Do I need cholangloscopy?

Torsten Beyna 1, Katarzyna Pawlak 2

1 Evangel. Krankenhaus Düsseldorf, Düsseldorf, Germany

2 Hospital of the Ministry of Interior and Administration, Szczecin, Poland

Event

UEG Week Berlin 2025

Session

Crash course: Tough endoscopists for tough stones

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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ESGE Live Endoscopy III (Complete Session)

Event

UEG Week Berlin 2025

Topics

Endoscopy Nurses

Session

ESGE Live Endoscopy III

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Poster

Audio / Video Poster

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Introduction

Placebo and treatment response rates in randomized ulcerative colitis (UC) trials impact clinical trial design and patients required to demonstrate efficacy. Prior efforts to predict endoscopic healing (EH) in UC trial patients using clinical measures have failed to produce meaningful predictive power. Using AI analysis of baseline endoscopy videos from the ustekinumab UNIFI registration Phase 3 trial in moderate to severe UC, we demonstrate robust accuracy to predict 8 week endoscopic healing in ulcerative colitis patients treated with placebo or drug.

Aims & Methods

300 screening endoscopy videos were obtained from UC patients receiving placebo, and 606 screening endoscopy videos were obtained from UC patients receiving ustekinumab (130mg or 6mg/kg) in the UNIFI induction trial. For all videos, visual features were extracted using EndoDINO, an AI foundation model pre-trained on the largest reported endoscopy video dataset. For each patient, 21 baseline clinical measures were also obtained as predictors. These included fecal calprotectin, albumin, C-reactive protein, lactoferrin, Geboes grading, prior biologics failure, prior steroids failure, UCEIS scores, and Mayo scores.
For each of the placebo and drug arms, we trained two binary classification models: one using the AI visual features and the other using the baseline clinical measures as predictors. Each model was trained to predict 8 week EH, defined as an endoscopy subscore of the Mayo score equal to 0 or 1. We performed 5-fold cross validation and reported the average Area Under the Receiver Operating Curve (AUROC).
This study, carried out under YODA Project # 2024-0668, used data obtained from the Yale University Open Data Access Project, which has an agreement with JANSSEN RESEARCH & DEVELOPMENT, L.L.C.. The interpretation and reporting of research using this data are solely the responsibility of the authors and does not necessarily represent the official views of the Yale University Open Data Access Project or JANSSEN RESEARCH & DEVELOPMENT, L.L.C.. The original proposal can be found: https://yoda.yale.edu/data-request/2024-0668/.

Results

For the placebo arm, our best performing model using AI visual features predicted 8 week endoscopic healing with an AUROC of 0.78, compared to 0.70 for our best performing model using the combination of 21 baseline clinical measures.
For the drug arm, our best performing model using AI visual features predicted 8 week endoscopic healing with an AUROC of 0.75, compared to 0.72 for our best performing model using the combination of 21 baseline clinical measures.
For models using baseline clinical measures, table 1 shows the importance factor for select measures across arms, calculated using XGBoost built in feature importance.

Clinical Measure	Placebo EH Model	Drug EH Model
Mayo endoscopic subscore	0.00	0.13
C-reactive protein	0.22	0.17
Fecal calprotectin	0.12	0.06
Screening erosion	0.32	0.02
Prior biologics failure	0.00	0.01

Conclusion

Our results demonstrate AI analysis of baseline colonoscopy videos with the EndoDINO AI foundation model provides robust accuracy for predicting 8 week EH in ulcerative colitis patients in both placebo and drug arms. AI placebo response prediction could be used in future trial design as covariate analysis to increase statistical power or reduce necessary sample size.
In future work, we aim to improve predictive power by combining our AI visual features with the most important baseline clinical measures through different modeling techniques.

References

Sands BE, Sandborn WJ, Panaccione R, et al. Ustekinumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2019;381(13):1201–1214. doi:10.1056/NEJMoa1900750

Disclosure

AK, PD, MC, and MS are employees of Virgo Surgical Video Solutions, Inc., which developed technology used in this work.

PREDICTION OF 8 WEEK ENDOSCOPIC HEALING IN ULCERATIVE COLITIS SUBJECTS FROM THE USTEKINUMAB UNIFI TRIAL USING ARTIFICIAL INTELLIGENCE (AI) ANALYSIS OF BASELINE COLONOSCOPY VIDEOS

Angad Kalra 1, Patrick Dermyer 1, Manisha Cole 1, Bram Verstockt 2, Matt Schwartz 1, Florian Rieder 3

1 Virgo Surgical Video Solutions, Inc., Carlsbad, United States

2 University Hospitals Leuven and KU Leuven, Translational Research in Gastrointestinal Disorders - IB, Leuven, Belgium

3 Cleveland Clinic Foundation, Cleveland Heights, United States

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Using AI to tackle IBD (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Introduction

UC-SCALE[1] is an AI algorithm designed to assess endoscopic severity in ulcerative colitis (UC). It was trained on a large subset of Phase III Etrolizumab (ETRO) clinical trial data from 471 sites. In our previous work, UC-SCALE previously demonstrated excellent agreement (quadratic-weighted kappa >0.80) with centrally read Mayo Clinic Endoscopic Subscores (MCES) on an ETRO test set spanning 83 sites. While clinical trial data is highly controlled, its generalizability to real-world settings remained untested. Here, we assess UC-SCALE on a retrospective cohort from the Paris IBD Center, which we refer to as the Real World Dataset (RWD).

Aims & Methods

The RWD contained 276 unique UC patients (mean 1.17 visits/patient) from the Paris IBD center. For each colonoscopy video, two or three local gastroenterologists reviewed the recordings and reached a consensus MCES (0–3) per colonic segment (descending, sigmoid, rectum). Using the same, unmodified UC-SCALE model trained on ETRO, we evaluated both the RWD and ETRO test sets with the identical assessment protocol detailed in [1]. Quadratic-Weighted Kappa (QWK) quantified the agreement between ordinal predictions made by UC-SCALE and human scoring. Area Under the Receiver Operating Characteristic Curve (AUC) was used to measure the discriminative ability for each MCES class.

Results

On these real-world data, UC-SCALE’s section-level predictions closely mirrored local expert scoring. QWK reached ~0.804 - virtually identical to ETRO (~0.802). For class-specific discrimination (MCES 0–3), AUC values exceeded 0.85 in all classes and in several cases surpassed ETRO’s results. The average AUC across all classes approached 0.90 in the RWD, aligning well with performance in trial conditions. As in ETRO, performance was strongest for Mayo 0 and 3, but notably, predictions for intermediate scores (Mayo 1 and 2) were even more accurate in RWD. These results highlight UC-SCALE’s robust generalizability to routine clinical practice.

Metric	RWD	ETRO	Difference
Quadratic Weighted Kappa	0.80 (0.77, 0.84)	0.80 (0.78, 0.82)	0.00
AUC Mayo 0	0.94 (0.93, 0.96)	0.94 (0.93, 0.95)	-0.00
AUC Mayo 1	0.85 (0.81, 0.88)	0.81 (0.78, 0.83)	0.04
AUC Mayo 2	0.90 (0.88, 0.92)	0.82 (0.80, 0.84)	0.08
AUC Mayo 3	0.92 (0.89, 0.94)	0.91 (0.90, 0.93)	0.01
AUC Mean	0.90 (0.89, 0.92)	0.87 (0.86, 0.88)	0.03

Table 1: Performance metrics for UC-SCALE on Real-World Data (RWD) versus the Etrolizumab (ETRO) trial dataset. The performance values are presented with 95% confidence intervals, which were derived through bootstrapping using 10,000 resamples.

Conclusion

Applying the original ETRO-trained UC-SCALE model to a real-world UC cohort confirmed its high accuracy and reliability for objective MCES scoring outside of clinical trials. To date, our analysis has focused on predictions at the level of anatomical segments. Future work will expand toward full video-level scoring (closer to clinical workflows) and artificial segments, which offer a more granular topological severity map. Additionally, upcoming analyses will explore correlations between UC-SCALE and key IBD biomarkers, as well as direct comparisons with human scoring.

References

[1] Gutierrez-Becker, Benjamin, et al. "Ulcerative Colitis Severity Classification and Localized Extent (UC-SCALE): An Artificial Intelligence Scoring System for a Spatial Assessment of Disease Severity in Ulcerative Colitis." Journal of Crohn's and Colitis 19.1 (2025): jjae187.

Disclosure

Alvaro Gomariz, Bernhard Stimpel, Benjamin Gutierrez-Becker, Stefan Frässle, Emily Fisher, Steven Levitte and Teresa Karrer are employees of F. Hoffmann-La Roche Ltd.

REAL-WORLD EVIDENCE VALIDATES AI-BASED ENDOSCOPIC SCORING FOR ULCERATIVE COLITIS

Alvaro Gomariz 1, Bernhard Stimpel 1, Carmen Stefanescu 2, Benjamin Gutierrez Becker 1, Stefan Frässle 1, Rafal Girycki 1, Emily Fisher 1, Yoram Bouhnik 2, Steven Levitte 3, Teresa Karrer 1

1 Roche, Basel, Switzerland

2 Institut des MICI, Neuilly-sur-Seine, France

3 Genentech, South San Francisco, United States

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Using AI to tackle IBD (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

UEG Poster

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Introduction

The lack of reliable intestinal fibrosis imaging modalities hampers anti-fibrotic therapy development. Gallium-68 Fibroblast Activation Protein inhibitor (⁶⁸GaFAPi) PET/CT offers promising in vivo fibrosis visualization via Fibroblast Activation Protein (FAP) targeting. Despite reported overexpression of FAP in chronic inflammatory and fibrotic diseases, data in inflammatory bowel disease (IBD) and the potential use of ⁶⁸Ga-FAPi PET/CT as a non-invasive fibrosis biomarker remains sparse. We performed the first in-human study to investigate ⁶⁸Ga-FAPi PET/CT to detect and quantify fibrosis in IBD patients using pharmacokinetic modelling.

Aims & Methods

Symptomatic patients with active Crohn’s disease (CD) or ulcerative colitis (UC) waiting for surgical resection were invited to the study and consented. Patients underwent a 60-minute dynamic ⁶⁸Ga-FAPi PET/CT scan, followed by 12 minutes of static imaging within 12 weeks before surgery. Arterial and peripheral blood samples were obtained during the first 10 scans to validate image- versus plasma-derived input function. Two blinded readers independently assessed the PET/CT images, wherein bowel segments showing increased uptake against local background were delineated and validated by a non-blinded third reader. Bowel segment uptake, time-activity-curves (TAC) and input functions were analyzed using irreversible (2T3k), reversible two-tissue compartment models (2T4k), reference tissue models, and standardized uptake values acquired on static images 50-60 minutes post-injection (SUV_50-60). Surgical resection specimens were selected based on ⁶⁸Ga-FAPi PET/CT with focus on segments with high FAPi uptake. In the tissue samples, gene expression and protein levels of FAP were determined using quantitative polymerase chain reaction (qPCR) and immunohistochemistry. To allocate samples to a fibrotic, inflamed or combined phenotype, hematoxylin and eosin and Masson’s trichrome staining were performed for inflammatory activity and fibrosis scoring by a blinded pathologist (GH) using previously described histological inflammation and fibrosis scores.¹

Results

In total, 15 CD and 4 UC patients (mean age 39 years, median disease duration 12 years) underwent FAPi PET/CT prior to surgery. On these 19 scans, 50 bowel regions of interest were identified and 52 transmural surgical samples were acquired. FAPi tracer uptake was markedly increased in inflamed and fibrotic regions of all participants compared to reference, non-pathologic bowel segments (SUV_50-60ranging 1.0 to 11 versus 0.3 to 1.1). Although a higher tracer activity was seen in all patients, the inflammatory bowel segments showed the highest peak in tracer activity, followed by a decline in uptake, indicating increased blood flow, vascular permeability and reversible, potentially non-specific or low-binding affinity, uptake. Contrarily, the TAC of patients with a more fibrotic phenotype, showed a low peak uptake followed by a relatively stable plateau, suggesting a more irreversible or higher binding affinity uptake component.

Conclusion

⁶⁸Ga-FAPi PET/CT shows significant promise for IBD assessment as uptake aligns with histological fibrosis scoring, enhanced FAP gene and protein expression in resected inflammatory and stenotic specimens in CD and UC patients. Pharmacokinetic analyses suggests more frequent irreversible uptake kinetics, indicating higher FAP binding affinity, in predominantly fibrotic segments compared to inflamed regions, thus underscoring its potential to differentiate fibrosis from inflammation.

References

1. Ke BJ, Abdurahiman S, Biscu F, Zanella G, et al. Intercellular interaction between FAP+ fibroblasts and CD150+ inflammatory monocytes mediates fibrostenosis in Crohn's disease. J Clin Invest. 2024 Jul 23;134(16):e173835. doi: 10.1172/JCI173835. PMID: 39042469; PMCID: PMC11324301.

Disclosure

M.L.: Consultancy/lecture fees from Abbvie, Bristol Myers Squibb, Eli Lilly, Galapagos, Janssen-Cilag, Johnson & Johnson, Medtronic, Pfizer, Takeda, Tillotts. Central reader for Alimentiv. Grants received from ZonMW, Galapagos, NFU transformation deal, and TKI (unrelated)
G.R.A.M.D.: research grants from Abbvie, Alimentiv, BMS, J&J, Pfizer, Takeda; consulting fees from Abbvie, Agomab, Alimentiv, AstraZeneca, AMT, Bristol Meiers Squibb, Boehringer Ingelheim, Celltrion, Eli Lilly, Exeliom Biosciences, Galapagos, Index Pharmaceuticals, Glaxo Smith Kline, Pfizer, Johnson and Johnson, Polpharma, Procise Diagnostics, Prometheus laboratories, Prometheus Biosciences, Protagonist, and Ventyx; speaker’s fees from Abbvie, Celltrion, Galapagos, Pfizer, and Takeda; data monitoring board: Galapagos, AstraZeneca, Seres Health (unrelated)

DETECTION OF FIBROSIS AND DIFFERENTIATION FROM INFLAMMATION IN IBD PATIENTS USING FAPI PET/CT IMAGING: THE PIMAFI STUDY

Dalia Alexia Lartey 1, Kelly van Wijnbergen 1, Bo Jun Ke 2, Christianne Johanna Buskens 1, Jarmila van Der Bilt 3, Gianluca Matteoli 2, Gert De Hertogh 4, Joep Grootjans 1, Manon E. Wildenberg 5, Sanne E. Wiegers 1, Maqsood M. Yaqub 1, Geert R. D'Haens 1, Gerben J. C. Zwezerijnen 1, Mark Lowenberg 1

1 Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands

2 KU Leuven, Leuven, Belgium

3 Flevoziekenhuis, Almere, Netherlands

4 University Hospital Leuven, Leuven, Belgium

5 AMC Amsterdam, Amsterdam, Netherlands

Conference

UEG Week Berlin 2025

Topics

IBD

Submission format

Abstract

Session

Advances in fibrosis research in Crohn's disease (Posters)

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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10 YEARS OF EUS-GUIDED ENTERO-ENTERAL ENDOSCOPIC BYPASS (EEEB) AND SUBSEQUENT ERC TO TREAT HEPATICO-JEJUNOSTOMY'S ANASTOMOTIC STRICTURES

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Introduction

Since re-do surgery and interventional radiology are considered the first-line treatment for bilio-digestive anastomotic stricture, endoscopic treatment has been used as a minimally invasive alternative for the management of these adverse event considering both EUS-guided and retrograde approaches. We proposed a totally endoscopic approach to improve the endotherapy of bilio-digestive anastomotic stricture. [1-2]

Aims & Methods

From January 2014 to December 2023, 87 consecutive patients affected by bilio- digestive anastomotic stricture treated by endoscopic enteral-enteral bypass (EEEB) and subsequent endoscopic retrograde cholangiography (ERC) were included in the present study. 77 patients underwent hepaticojejunostomy on Roux-en-Y loop; 10 patients underwent Whipple-Child procedure.

Results

87 consecutive patients (mean age= 66 y.o.; 53 M, 34 F) underwent EEEB which was successful in all but two patients because of a perforation secondary to bypass stent misplacement during the stent’s release and an intraprocedural bleeding (technical success rate in 85/87, 97.5%). When EEEB was successfully performed in all the cases with the effective treatment of the anastomotic biliary stricture using large bore fully-covered self-expandable metal stents (SEMS). During a mean follow-up of 66 months (range: 12-120 months), we reported a 100% clinical success (defined as clinical complete resolution of the stricture). In seven cases, recurrent biliary stricture occurred, successfully re-treated through the EEEB (biliary strictures’ recurrence rate: 8.2%). Five cases of buried flair of the lumen-apposing metal stent used for the EEEB into the gastric wall were reported; four treated by pneumatic dilation and stent-in-stent treatment and one by redo EEEB. No other long-term adverse events were experienced.

Conclusion

EEEB-guided ERC is safe, feasible, and effective in tertiary referral centers with high-level experience in both ERCP and EUS. It lets the use of endoscopes with large operative channel to treat the stenosis with large-bore SEMS to manage complex and multiple-ducts biliary anastomosis’ strictures, to guarantee a long-lasting gradual dilation and to re-treat the patients in case of recurrence. [3]

References

[1] Mutignani M, et al. Endoscopic entero-enteral bypass: an effective new approach to the treatment of postsurgical complications of hepaticojejunostomy. Endoscopy 2019; 51: 1146-1150.

[2] Mutignani M, et al. Endoscopic entero-enteral bypass to treat postsurgical benign complications of hepatico-jejunostomy: Update of a 7-year single-center experience. Endosc Int Open. 2023 Apr 24;11(4):E394-E400. doi: 10.1055/a-2032-3077. PMID:37102184; PMCID: PMC10125775.

[3] Mutignani M, et al. Letter to Editor on “Comparison between endoscopic biliary stenting combined with balloon dilation and balloon dilation alone for treatment of benign hepaticojejunostomy anastomotic stricture.”. J Gastrointest Surg 2019;doi.org/10.1007/s11605-019-04450-3.

10 YEARS OF EUS-GUIDED ENTERO-ENTERAL ENDOSCOPIC BYPASS (EEEB) AND SUBSEQUENT ERC TO TREAT HEPATICO-JEJUNOSTOMY'S ANASTOMOTIC STRICTURES

Marta Pagliaro 1, Lorenzo Dioscoridi 1, Camilla Gallo 1, Giulia Bonato 1, Francesco Pugliese 1, Andrea Palermo 1, Marianna Bravo 1, Marcello Cintolo 1, Edoardo Forti 1, Massimiliano Mutignani 1

1 ASST Great Metropolitan Hospital Niguarda, Milano, Italy, Milano, Italy

Event

UEG Week Berlin 2025

Topics

Endoscopy Hepatobiliary

Submission format

Abstract

Session

Textbook knowledge and limits of HPB endoscopy

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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