Clinical trial · Observational
Precision of Optical Diagnosis in Polyps Between 5-15 mm and Its Implications on Surveillance. A Prospective, Multicenter Study.
NCT04232176CI-TRIAL-00058536POPScompletedClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study evaluates the ability of endoscopists to perform a complete optical diagnosis of colorectal polyps between 5 and 15 mm, and the impact of the only endoscopic diagnosis on the follow-up program for those patients. This is a prospective study in which we compare the diagnosis regarding size and histology made by the endoscopist versus de pathologic diagnosis.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colonic Polyps | — | UNRESOLVED | — |
| Colon Neoplasms | Colon Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Serrated Adenoma | Traditional Serrated Adenoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Concordance of optical diagnosis with pathologic diagnosis
- timeFrame
- Immediate after the polyps detection
- description
- Optical diagnosis accuracy (endoscopist) when compared to the Pathologic report
- measure
- Precision in polyps sizing the pathologist
- timeFrame
- Immediate after resection and within 10 days after polyp resection to allow pathologic diagnosis
- description
- Comparison of sizes after resection and after formaline and pathologic diagnosis
Secondary outcomes (1)
- measure
- Rate of polyps' recurrence at the end of the follow-up.
- timeFrame
- 5 years after the index resection
- description
- Polyps recurrence after long-term follow up for advanced adenoma (Rate)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18-80 years * Colorectal polyps with an estimated size (endoscopist estimation) between 5 and 15 mm. * Consent to be included in the protocol. Exclusion Criteria: * Polyps sized \<5 mm or \>15 mm * Polyps that cannot be resected. * Polys that cannot be sent for pathologic study. * Peacemeal resection. * Polyposis syndromes with a previous histologic diagnosis. * Patients do not consent to participate in the study.
References
Publications (11)
- BACKGROUNDHeitman SJ, Ronksley PE, Hilsden RJ, Manns BJ, Rostom A, Hemmelgarn BR. Prevalence of adenomas and colorectal cancer in average risk individuals: a systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2009 Dec;7(12):1272-8. doi: 10.1016/j.cgh.2009.05.032. Epub 2009 Jun 10. PMID 19523536
- BACKGROUNDButterly LF, Chase MP, Pohl H, Fiarman GS. Prevalence of clinically important histology in small adenomas. Clin Gastroenterol Hepatol. 2006 Mar;4(3):343-8. doi: 10.1016/j.cgh.2005.12.021. PMID 16527698
- BACKGROUNDMason SE, Poynter L, Takats Z, Darzi A, Kinross JM. Optical Technologies for Endoscopic Real-Time Histologic Assessment of Colorectal Polyps: A Meta-Analysis. Am J Gastroenterol. 2019 Aug;114(8):1219-1230. doi: 10.14309/ajg.0000000000000156. PMID 30848728
- BACKGROUNDRex DK, Kahi C, O'Brien M, Levin TR, Pohl H, Rastogi A, Burgart L, Imperiale T, Ladabaum U, Cohen J, Lieberman DA. The American Society for Gastrointestinal Endoscopy PIVI (Preservation and Incorporation of Valuable Endoscopic Innovations) on real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2011 Mar;73(3):419-22. doi: 10.1016/j.gie.2011.01.023. PMID 21353837
- BACKGROUNDKaminski MF, Hassan C, Bisschops R, Pohl J, Pellise M, Dekker E, Ignjatovic-Wilson A, Hoffman A, Longcroft-Wheaton G, Heresbach D, Dumonceau JM, East JE. Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2014 May;46(5):435-49. doi: 10.1055/s-0034-1365348. Epub 2014 Mar 17. PMID 24639382
- BACKGROUNDMcGill SK, Evangelou E, Ioannidis JP, Soetikno RM, Kaltenbach T. Narrow band imaging to differentiate neoplastic and non-neoplastic colorectal polyps in real time: a meta-analysis of diagnostic operating characteristics. Gut. 2013 Dec;62(12):1704-13. doi: 10.1136/gutjnl-2012-303965. Epub 2013 Jan 7.