Clinical trial · Observational
AI in Predicting Polyp Pathology and Endoscopic Classification
Artificial Intelligence Predicts the Pathology and Endoscopic Classification of Colorectal Polyps During Colonoscopy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: Colonoscopy with optical diagnosis based on the appearance of polyps can guide the selection of endoscopic treatment methods, reduce unnecessary polypectomy procedures and the need for tissue pathological diagnosis, and formulate follow-up strategies in a timely manner \[1\]. This approach significantly alleviates the economic burden on patients and the healthcare system and can effectively ease the tension on clinical resources \[2\]. Various endoscopic polyp classification methods, including Pit Pattern \[3\], NICE \[4\], WASP \[5\], and MS \[6\], are used to determine pathological types. However, mastering these classification methods requires endoscopists to undergo extensive training, and due to the inherent flaws in each method, no single endoscopic classification method can accurately diagnose all types of polyps to meet the requirements of optical diagnosis. This limitation has hindered the widespread application of optical diagnosis in clinical practice \[7\]. The application of artificial intelligence technology in this field, known as computer-aided diagnosis (CADx), has seen rapid development in recent years. Numerous large-scale, prospective studies have demonstrated that the accuracy of CADx technology for optical diagnosis of minute lesions (\<5mm) has essentially met the threshold set by European and American endoscopy societies for optical diagnosis \[8,9\]. However, the diagnostic efficacy of CADx for polyps ≥5mm remains unclear. Moreover, current research is mostly limited to distinguishing between common adenomas and hyperplastic polyps, with little attention given to serrated lesions, which are also precancerous lesions and progress even more rapidly, and are more challenging for endoscopists to assess. These reasons prevent CADx from being widely applied in clinical practice for real-time accurate judgment of polyp pathological types.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Polyps | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Real-time Artificial Intelligence Model for Diagnosing Colorectal Polyp Pathology and Endoscopic Classification | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients aged 18 years or older undergoing routine colonoscopy screening
- interventionNames
- Diagnostic Test: Real-time Artificial Intelligence Model for Diagnosing Colorectal Polyp Pathology and Endoscopic Classification
Primary outcomes (1)
- measure
- Accuracy of Optical Diagnosis for Colorectal Polyps
- timeFrame
- 2 years
- description
- The accuracy of the AI model's optical diagnosis is compared with that of endoscopists, with pathological diagnosis serving as the gold standard.
Secondary outcomes (3)
- measure
- Other Assessment Parameters of Optical Diagnosis
- timeFrame
- 2 years
- description
- Including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of Optical Diagnosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Outpatients or inpatients undergoing routine colonoscopy screening at the endoscopy centers of multicenter hospitals; 2. Aged 18 years or older; 3. Have understanding of the study content and have signed the informed consent form. Exclusion Criteria: 1. Gastroparesis or gastric outlet obstruction; 2. Known or suspected intestinal obstruction or perforation; 3. Severe chronic renal failure (creatinine clearance less than 30 mL/minute); 4. Severe congestive heart failure (New York Heart Association Class III or IV); 5. Currently pregnant or breastfeeding; 6. Toxic colitis or megacolon; 7. Poorly controlled hypertension (systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 100 mmHg); 8. Moderate or massive active gastrointestinal bleeding (\>100 mL/day); 9. Significant psychiatric or psychological illness; 10. Allergy to medications used for bowel preparation; 11. Patients who have undergone colorectal surgery.
References
Publications (9)
- BACKGROUNDvan der Zander QEW, Schreuder RM, Fonolla R, Scheeve T, van der Sommen F, Winkens B, Aepli P, Hayee B, Pischel AB, Stefanovic M, Subramaniam S, Bhandari P, de With PHN, Masclee AAM, Schoon EJ. Optical diagnosis of colorectal polyp images using a newly developed computer-aided diagnosis system (CADx) compared with intuitive optical diagnosis. Endoscopy. 2021 Dec;53(12):1219-1226. doi: 10.1055/a-1343-1597. Epub 2021 Mar 10. PMID 33368056
- BACKGROUNDZachariah R, Samarasena J, Luba D, Duh E, Dao T, Requa J, Ninh A, Karnes W. Prediction of Polyp Pathology Using Convolutional Neural Networks Achieves "Resect and Discard" Thresholds. Am J Gastroenterol. 2020 Jan;115(1):138-144. doi: 10.14309/ajg.0000000000000429. PMID 31651444
- BACKGROUNDRees CJ, Rajasekhar PT, Wilson A, Close H, Rutter MD, Saunders BP, East JE, Maier R, Moorghen M, Muhammad U, Hancock H, Jayaprakash A, MacDonald C, Ramadas A, Dhar A, Mason JM. Narrow band imaging optical diagnosis of small colorectal polyps in routine clinical practice: the Detect Inspect Characterise Resect and Discard 2 (DISCARD 2) study. Gut. 2017 May;66(5):887-895. doi: 10.1136/gutjnl-2015-310584. Epub 2016 Apr 19. PMID 27196576
- BACKGROUNDSingh R, Jayanna M, Navadgi S, Ruszkiewicz A, Saito Y, Uedo N. Narrow-band imaging with dual focus magnification in differentiating colorectal neoplasia. Dig Endosc. 2013 May;25 Suppl 2:16-20. doi: 10.1111/den.12075. PMID 23617643
- BACKGROUNDIJspeert JE, Bastiaansen BA, van Leerdam ME, Meijer GA, van Eeden S, Sanduleanu S, Schoon EJ, Bisseling TM, Spaander MC, van Lelyveld N, Bargeman M, Wang J, Dekker E; Dutch Workgroup serrAted polypS & Polyposis (WASP). Development and validation of the WASP classification system for optical diagnosis of adenomas, hyperplastic polyps and sessile serrated adenomas/polyps. Gut. 2016 Jun;65(6):963-70. doi: 10.1136/gutjnl-2014-308411. Epub 2015 Mar 9. PMID 25753029
- BACKGROUNDTanaka S, Sano Y. Aim to unify the narrow band imaging (NBI) magnifying classification for colorectal tumors: current status in Japan from a summary of the consensus symposium in the 79th Annual Meeting of the Japan Gastroenterological Endoscopy Society. Dig Endosc. 2011 May;23 Suppl 1:131-9. doi: 10.1111/j.1443-1661.2011.01106.x.