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A MULTICENTER PROSPECTIVE OBSERVATIONAL STUDY OF THE PREDICTION OF ADVANCED HISTOLOGY IN SMALL COLORECTAL POLYPS USING IMAGE-ENHANCED ENDOSCOPY: THE ADVENTURE TRIAL

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Introduction

In recent years, cold snare polypectomy (CSP) for small polyps has become popular, but it is considered inappropriate as a treatment for cancer because of the shallow depth of resection at the muscularis mucosa level and the risk of inadequate pathological evaluation. ¹² Therefore, it is important to diagnose advanced histology (AH) (high grade adenoma or adenocarcinoma) prior to treatment. Based on our retrospective review of colorectal neoplastic lesions smaller than 10 mm, the following six endoscopic findings were extracted as significant predictors of AH findings in the multivariate analysis : (1) surface redness, (2) white spots, using white light image, (3) heterogeneity in mucosal pattern, using non-magnified Narrow band imaging (NBI), (4) irregular vessel or surface pattern(equivalent to JNET Type 2B,3), using magnified NBI, (5) loss of lobulation, and (6) non-polypoid growth, using non-magnified chromoendoscopy using indigo carmine. ³

Aims & Methods

The aim of this study was to evaluate the usefulness of image-enhanced endoscopic findings in real-time prediction of AH for small colorectal polyps. Patients scheduled for colonoscopy were recruited for consent prior to the examination at 9 Japanese institutions, and the presence of the aforementioned AH-predictive endoscopic findings was noted for up to 5 lesions per patient when neoplastic polyps of 5-9 mm were detected. If one of the predictive findings was positive, endoscopic resection using the electric current method or surgical resection was applied. The primary endpoint was the negative predictive value (NPV) of the 6 AH-predicting findings using pathology as the gold standard. Secondary endpoints were NPV of AH prediction by modality combination, odds ratios of each predictors and percentage of non-CSP for T1 cancer. Taking account for practical value, the target threshold of NPV was set for 90%.

Results

A total of 1671 patients were enrolled in the study, of which 517 patients with 849 lesions (80 AH lesions) corresponding to 5-9 mm polyps were included in the analysis. The primary endpoint was 0.945 (95% confidence interval (CI): 0.923-0.961). Secondary endpoints were white light + NBI non-magnified/magnified 0.941 (95%CI: 0.920-0.958), white light + NBI non-magnified 0.934 (95%CI: 0.913-0.952), white light + chromoendoscopy 0.926 (95%CI: 0.904-0.944), and white light 0.922 (95%CI: 0.900-0.940). Odds ratio (95%CI) of each 6 findings were as followings; irregular vessel or surface pattern 5.00 (2.59-9.37), loss of lobulation 4.10(1.61-6.56), white spots 3.32(1.60-6.56), non-polypoid growth 3.24(1.13-8.22), heterogeneity 2.53(1.41-4.42), surface redness 1.41(0.56-3.14). All 6 T1 cancer had multiple predictive findings of AH, and the percentage of non-CSP performed was 100%.

Conclusion

Six predictive findings of AH combined with image-enhanced endoscopy were shown to be useful in determining the indication for CSP (UMIN 000040974).

References

1. Ito A, Suga T, Ota H, et al. Resection depth and layer of cold snare polypectomy versus endoscopic mucosal resection. J Gastroenterol 2018;53:1171-1178.
2. Uraoka T, Takizawa K, Tanaka S, et al. Guidelines for Colorectal Cold Polypectomy (supplement to "Guidelines for Colorectal Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection"). Dig Endosc 2022;34:668-675.
3. Iwai T, Imai K, Hotta K, et al. Endoscopic prediction of advanced histology in diminutive and small colorectal polyps. J Gastroenterol Hepatol 2019;34:397-403.

A MULTICENTER PROSPECTIVE OBSERVATIONAL STUDY OF THE PREDICTION OF ADVANCED HISTOLOGY IN SMALL COLORECTAL POLYPS USING IMAGE-ENHANCED ENDOSCOPY: THE ADVENTURE TRIAL

Hiroki Yamashita 1, Kinichi Hotta 2, Yoji Takeuchi 3, Tomohiro Iwai 4, Kazuya Ohno 5, Kazuya Hosotani 6, Toshihiro Kusaka 7, Takuji Kawamura 8, Shinya Sugimoto 9, Yasuhiro Tani 3, Yoshihiro Kishida 2, Shigehiko Fujii 7, Takahiro Inoue 3, Hiromu Fukuda 3, Tatsuro Murano 1, Sayo Ito 2, Kenichiro Imai 2, Hiroaki Ikematsu 1

1 National Cancer Center Hospital East, Kashiwa, Japan

2 Shizuoka Cancer Center, Sunto, Japan

3 Osaka International Cancer Institute, Osaka, Japan

4 Toyokawa City Hospital, Toyokawa, Japan

5 Shizuoka General Hospital, Shizuoka, Japan

6 Kobe City Medical Center General Hospital, Kobe, Japan

7 Kyoto Katsura Hospital, Kyoto, Japan

8 Kyoto Second Red Cross Hospital, Kyoto, Japan

9 Ise Red Cross Hospital, Ise, Japan

Event

UEG Week Copenhagen 2023

Topics

Colorectal Digestive Oncology Endoscopy Histopathology Radiology & Imaging

Submission format

Abstract

Session

Advanced imaging for advanced colorectal lesion

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

UEG Presentation

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REAL-LIFE VS CLINICAL TRIAL ACCESS TO BIOLOGICAL THERAPY: FINDINGS FROM AN ITALIAN-AMERICAN STUDY ON INFLAMMATORY BOWEL DISEASE

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Introduction

Treatment goals in inflammatory bowel disease (IBD) have evolved beyond symptom control to include mucosal healing, prevention of disease-related complications, improvement of health-related quality of life, and reduction of long-term disability, as outlined by the STRIDE II initiative¹. Despite significant progress in the development of advanced therapies (ADTs), up to 50% of IBD patients fail to respond to currently available treatments, underscoring the urgent need for new therapies, which are investigated in randomized clinical trials (RCTs). However, stringent eligibility criteria in RCTs limit the inclusion of real-world IBD patients, potentially compromising the generalizability of trial findings to daily clinical practice.

Aims & Methods

The aim of this study was to evaluate the proportion of real-life IBD patients who would be eligible for ongoing RCTs and to assess the representativeness of this population. Moreover, we aimed to identify the most frequently unmet eligibility criteria leading to patient exclusion and to characterize the clinical profiles that differentiate eligible from ineligible patients.
This prospective, observational, multicenter study was conducted between October 2023 and October 2024 at 2 tertiary IBD referral centers: the Fondazione Policlinico Universitario “A. Gemelli” in Rome, Italy, and the Crohn’s & Colitis Center at the University of Miami, USA. Consecutive patients with IBD indicated for a new ADT were enrolled. Each patient was systematically screened for inclusion and exclusion criteria across all actively recruiting phase 2b and 3 RCTs available at each center at the time of evaluation (6 RCTs in Rome: 4 UC and 2 CD; 5 RCTs in Miami: 3 UC and 2 CD).

Results

A total of 166 IBD patients (69 UC and 97 CD) were enrolled, with 129 patients from the Italian cohort and 37 from the American cohort. Among UC patients, only 16 (23.2%) met the eligibility criteria for at least 1 RCT, whereas 53 (76.8%) were deemed ineligible (p<0.001). In the CD group, just 10 patients (10.3%) were eligible for at least 1 RCT, compared to 87 (89.7%) who were not (p<0.001). The most common reasons for ineligibility among UC patients included: Modified Mayo score not within the required range of 5–9 (50.7%), absence of bowel urgency (63.8%), Mayo Endoscopic Subscore <2 (39.1%), failure to comply with ADT washout requirements (56.5%), insufficient number of prior ADT failures (39.0%), and recent use of topical 5-ASA or steroids within 4 weeks prior to screening (62.3%).
In CD patients, the most frequently unmet criterion was a CDAI between 220 and 450 (92.8%), followed by insufficiently liquid stool frequency (≥4 very soft or liquid stools/day; 75.3%), SES-CD<6 (39.2%), and the presence of CD-related complications such as strictures or fistulas (13.1%).

Conclusion

The majority of real-life IBD patients, particularly those with CD, are ineligible for participation in current RCTs—primarily due to relatively mild disease activity or ongoing need for concomitant therapies that are not permitted by trial protocols. Importantly, many real-world CD patients initiate new ADTs based on radiologic signs of disease activity, the presence of disease complications, or as prophylaxis for post-surgical recurrence, rather than clinical activity scores alone. Similarly, UC patients may require ADTs even in the context of corticosteroid dependence and low-grade disease activity. These findings underscore the need to revisit and broaden eligibility criteria in future RCTs to ensure greater external validity and alignment with the heterogeneity of real-life IBD population.

References

1. Turner D, Ricciuto A, Lewis A, D'Amico F, Dhaliwal J, Griffiths AM, Bettenworth D, Sandborn WJ, Sands BE, Reinisch W, Schölmerich J, Bemelman W, Danese S, Mary JY, Rubin D, Colombel JF, Peyrin-Biroulet L, Dotan I, Abreu MT, Dignass A; International Organization for the Study of IBD. STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD. Gastroenterology. 2021 Apr;160(5):1570-1583. doi: 10.1053/j.gastro.2020.12.031. Epub 2021 Feb 19. PMID: 33359090.

REAL-LIFE VS CLINICAL TRIAL ACCESS TO BIOLOGICAL THERAPY: FINDINGS FROM AN ITALIAN-AMERICAN STUDY ON INFLAMMATORY BOWEL DISEASE

Federica Di Vincenzo 1, Stephanie Ioannou 2, Chiara Principessa 3, Ivan Capobianco 1, Antonio Gasbarrini 4, Lucrezia Laterza 4, Maria T. Abreu 5, Franco Scaldaferri 4

1 Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Università Cattolica del Sacro Cuore, Roma, Italy

2 University of Miami - Jackson Health System, Miami, United States

3 Università Cattolica del Sacro Cuore, Roma, Italy

4 Fondazione Policlinico Universitario "A. Gemelli", IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy

5 University of Miami Miller School of Medicine, Department of Medicine, Division of Gastroenterology, Miami, FL 33136; F. Widjaja Inflammatory Bowel Disease Institute, Cedars-Sinai Medical Center, Los Angeles, United States