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
Not provided
| Name | Class |
|---|---|
| Fundación Pública Andaluza para la Investigación Biomédica AndalucÃa Oriental | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Background: Optical diagnosis of colonic polyps is an attractive possibility and a common practice. However, recommendations and the main decision concerning patients' management still rely on histological diagnosis, with controversial results in previous studies, usually designed to analyze the accuracy of this diagnosis in the setting of a 'resect and discard' or 'diagnose and leave' strategy. However, little has been studied on this diagnosis on polyps of about 10 mm, the threshold for the consideration as a high risk adenoma, that need a 3 year colonoscopy, or, in case of a smaller adenoma, with a recommended revision in 5 years. Some studies have addressed the accuracy when estimating the polyp size, and others the histology by means of virtual or optical chromoendoscopy, but no one has studied both parameters, that are the two pillars in which a revision program for the patient is decided.
Hypothesis: Our main purpose is to determine the accuracy of the complete optical diagnosis as made by the endoscopist in the endoscopy room, in order to give recommendations immediately after the colonoscopy, with no need of further histological analyses.
Aims:
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Concordance of optical diagnosis with pathologic diagnosis | Optical diagnosis accuracy (endoscopist) when compared to the Pathologic report | Immediate after the polyps detection |
| Precision in polyps sizing the pathologist | Comparison of sizes after resection and after formaline and pathologic diagnosis | Immediate after resection and within 10 days after polyp resection to allow pathologic diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of polyps' recurrence at the end of the follow-up. | Polyps recurrence after long-term follow up for advanced adenoma (Rate) | 5 years after the index resection |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients that come to the endoscopy unit for colorectal cancer screening or with a specific clinical indication during the study period, in any of the participating hospitals.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clara Heredia-Carrasco, MD | 'Virgen de las Nieves' University Hospital. Granada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Virgen de las Nieves" University Hospital | Granada | 18014 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19523536 | Background | Heitman 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. | |
| 16527698 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Butterly 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. |
| 30848728 | Background | Mason 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. |
| 21353837 | Background | Rex 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. |
| 24639382 | Background | Kaminski 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. |
| 23300139 | Background | McGill 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. |
| 25753029 | Background | IJspeert 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. |
| 29571175 | Background | Iacucci M, Trovato C, Daperno M, Akinola O, Greenwald D, Gross SA, Hoffman A, Lee J, Lethebe BC, Lowerison M, Nayor J, Neumann H, Rath T, Sanduleanu S, Sharma P, Kiesslich R, Ghosh S, Saltzman JR; SIMPLE classification investigator team. Development and validation of the SIMPLE endoscopic classification of diminutive and small colorectal polyps. Endoscopy. 2018 Aug;50(8):779-789. doi: 10.1055/s-0044-100791. Epub 2018 Mar 23. |
| 26191348 | Background | Izzy M, Virk MA, Saund A, Tejada J, Kargoli F, Anand S. Accuracy of endoscopists' estimate of polyp size: A continuous dilemma. World J Gastrointest Endosc. 2015 Jul 10;7(8):824-9. doi: 10.4253/wjge.v7.i8.824. |
| 27196576 | Background | Rees 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. |
| 34988735 | Derived | Redondo-Cerezo E, Heredia-Carrasco C, Alegria-Motte C, Caballero-Mateos A, Vadillo-Calles F, Ortega-Suazo EJ, Martos-Ruiz V, Ariza-Fernandez JL, Lopez-Gonzalez E, Martinez-Cara JG, Valverde-Lopez F, de Hierro ML, Sanchez-Capilla D, Lopez-Hidalgo JL, Jimenez-Rosales R. Accuracy in optical diagnosis for polyps between 5 and 15 mm and its implications on surveillance. A prospective, multicenter study. (POPS study). Surg Endosc. 2022 Jul;36(7):5356-5365. doi: 10.1007/s00464-021-08917-w. Epub 2022 Jan 6. |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |