Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Olympus | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This international multicentre prospective study aims to develop a new simple score using enhanced endoscopic techniques which focus on the vascular features of the colon and reliably distinguish between a quiescent and a mild inflammation in ulcerative colitis (UC). The diagnostic performance of the new score in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes will be evaluated. The study also aims to adapt current artificial intelligence (AI) algorithms for enhanced endoscopic techniques to improve standardization in UC disease assessment and outcome prediction.
This is a multicentre prospective international study. This study aims at developing a new simple endoscopic score using white light endoscopy - high definition (WLE-HD), Texture and colour enhancement imaging (TXI), red dichromatic imaging (RDI) and narrow-band imaging (NBI) modes, focusing on vascular features to distinguish between quiescent versus patchy mild Ulcerative Colitis. It will evaluate the new score's diagnostic performance in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes. Finally, it also aims to develop and adapt existing artificial intelligence (AI) algorithms according to WLE-HD, TXI, RDI and NBI to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcomes.
The study will be divided in several phases:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulcerative Colitis patients | UC patients who have been scheduled for colonoscopy for disease assessment or surveillance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy after bowel cleansing | Procedure | Colonoscopy will be performed using HD-WLE; TXI; RDI and NBI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of the new scoring system | To evaluate the diagnostic performance of the new score in evaluating endoscopic and histological activity | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation with existing score | To evaluate the new score's diagnostic performance in defining disease activity/remission compared to existing endoscopic and histological scores and predict long-term clinical outcomes | 2 years |
| AI development |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Males and females between 18 and 75 years old with an established diagnosis of UC, who have undergone colonoscopy for disease assessment and surveillance will be consecutively recruited after obtaining written consent. The sample size in 300.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle O'Riordan | Contact | +353 (0)21 4901759 | moriordan@ucc.ie |
| Name | Affiliation | Role |
|---|---|---|
| Marietta Iacucci, MD | University College Cork | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Leuven | Not yet recruiting | Leuven | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36279923 | Background | Rath T, Atreya R, Bodenschatz J, Uter W, Geppert CE, Vitali F, Fischer S, Waldner MJ, Colombel JF, Hartmann A, Neurath MF. Intestinal Barrier Healing Is Superior to Endoscopic and Histologic Remission for Predicting Major Adverse Outcomes in Inflammatory Bowel Disease: The Prospective ERIca Trial. Gastroenterology. 2023 Feb;164(2):241-255. doi: 10.1053/j.gastro.2022.10.014. Epub 2022 Oct 21. | |
| 36228649 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Blood, Intestinal biopsies, Stool
| Intestinal biopsies | Procedure | During colonoscopy, at least 2 biopsies from each segment will be taken as standard of care to assess inflammation in UC |
|
| blood sampling | Diagnostic Test | Blood samples will be taken for standard of care by appropriately trained members of the clinical research team. The results of the standard of care blood will be used in the research. |
|
| Stool | Diagnostic Test | The stool sample will be sent to the laboratory for Faecal Calprotectin (FCP) as a marker of disease activity. |
|
| Clinical follow-up | Other | Patients will be followed-up at 6 and 12 months after index endoscopy. Patients will be evaluated in clinic or by telephone call and the disease will be reassessed. Partial Mayo Score (PMS) and occurrence of clinical outcomes will be evaluated. |
|
Develop and adapt existing AI algorithms according to WLE-HD, TXI, RDI and NBI to grade and standardize endoscopic and histological disease assessment and predict long-term clinical outcomes in UC
| 2 years |
| Klinikum Luneburg | Not yet recruiting | Lüneburg | Germany |
|
| University College Cork | Recruiting | Cork | Co Cork | Ireland |
|
| Ospedale S. Maria del Prato | Not yet recruiting | Feltre | Belluno | Italy |
|
| University of Bari | Not yet recruiting | Bari | Italy |
|
| Istituto Clinico Humanitas | Not yet recruiting | Milan | Italy |
|
| University Vita-Salute San Raffaele | Not yet recruiting | Milan | Italy |
|
| University of Naples | Recruiting | Naples | Italy |
|
| University of Pavia | Not yet recruiting | Pavia | Italy |
|
| Showa University | Not yet recruiting | Tokyo | Japan |
|
| Changi General Hospital | Not yet recruiting | Singapore | Singapore |
|
| Background |
| Iacucci M, Cannatelli R, Parigi TL, Nardone OM, Tontini GE, Labarile N, Buda A, Rimondi A, Bazarova A, Bisschops R, Del Amor R, Meseguer P, Naranjo V, Ghosh S, Grisan E; PICaSSO group. A virtual chromoendoscopy artificial intelligence system to detect endoscopic and histologic activity/remission and predict clinical outcomes in ulcerative colitis. Endoscopy. 2023 Apr;55(4):332-341. doi: 10.1055/a-1960-3645. Epub 2022 Oct 13. |
| 36627537 | Background | Hashimoto Y, Kuribayashi S, Sato K, Itoi Y, Nakata K, Kasuga K, Tanaka H, Hosaka H, Ikota H, Iacucci M, Uraoka T. Validation of red dichromatic imaging score (RDI score) to evaluate the severity of ulcerative colitis. Surg Endosc. 2023 May;37(5):3627-3633. doi: 10.1007/s00464-022-09852-0. Epub 2023 Jan 10. |
| 33347880 | Background | Iacucci M, Smith SCL, Bazarova A, Shivaji UN, Bhandari P, Cannatelli R, Daperno M, Ferraz J, Goetz M, Gui X, Hayee B, De Hertogh G, Lazarev M, Li J, Nardone OM, Parra-Blanco A, Pastorelli L, Panaccione R, Occhipinti V, Rath T, Tontini GE, Vieth M, Villanacci V, Zardo D, Bisschops R, Kiesslich R, Ghosh S. An International Multicenter Real-Life Prospective Study of Electronic Chromoendoscopy Score PICaSSO in Ulcerative Colitis. Gastroenterology. 2021 Apr;160(5):1558-1569.e8. doi: 10.1053/j.gastro.2020.12.024. Epub 2021 Feb 6. |
| 29713677 | Background | Sasanuma S, Ohtsuka K, Kudo SE, Ogata N, Maeda Y, Misawa M, Mori Y, Kudo T, Hisayuki T, Wakamura K, Hayashi T, Katagiri A, Miyachi H, Baba T, Ishida F. Narrow band imaging efficiency in evaluation of mucosal healing/relapse of ulcerative colitis. Endosc Int Open. 2018 May;6(5):E518-E523. doi: 10.1055/s-0044-102297. Epub 2018 Apr 18. |
| 35847771 | Background | He T, Zong L, Pan P, Sun S, Qu H. Predicting Histological Healing and Recurrence in Ulcerative Colitis by Assessing Mucosal Vascular Pattern Under Narrow-Band Imaging Endoscopy. Front Med (Lausanne). 2022 Jun 30;9:869981. doi: 10.3389/fmed.2022.869981. eCollection 2022. |
| 36460084 | Background | Hayashi Y, Takabayashi K, Kato M, Tojo A, Aoki Y, Hagihara Y, Yoshida K, Yoshimatsu Y, Kiyohara H, Sugimoto S, Nanki K, Mikami Y, Sujino T, Mutaguchi M, Kawaguchi T, Hosoe N, Yahagi N, Ogata H, Kanai T. Usefulness of texture and color enhancement imaging in assessing mucosal healing in patients with ulcerative colitis. Gastrointest Endosc. 2023 Apr;97(4):759-766.e1. doi: 10.1016/j.gie.2022.11.019. Epub 2022 Nov 30. |
| 23839228 | Background | Neumann H, Vieth M, Gunther C, Neufert C, Kiesslich R, Grauer M, Atreya R, Neurath MF. Virtual chromoendoscopy for prediction of severity and disease extent in patients with inflammatory bowel disease: a randomized controlled study. Inflamm Bowel Dis. 2013 Aug;19(9):1935-42. doi: 10.1097/MIB.0b013e318290550e. |
| 33121688 | Background | Pabla BS, Schwartz DA. Assessing Severity of Disease in Patients with Ulcerative Colitis. Gastroenterol Clin North Am. 2020 Dec;49(4):671-688. doi: 10.1016/j.gtc.2020.08.003. Epub 2020 Sep 23. |
| 28964677 | Background | Katsanos KH, Papamichael K, Christodoulou DK, Cheifetz AS. Histological healing beyond endoscopic healing in ulcerative colitis: Shall we target the "ultra-deep" remission? Dig Liver Dis. 2017 Dec;49(12):1332-1333. doi: 10.1016/j.dld.2017.08.043. Epub 2017 Sep 18. No abstract available. |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D003672 | Defecation |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
Not provided
Not provided