Precision of Optical Diagnosis in Polyps Between 5-15 mm and Its Implications on Surveillance. A Prospective, Multicenter Study.

NCT04232176 | Completed

• 1 other identifier: POPS.HUVN.19
• Study Type: observational
• Target: 545
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colonic Polyps; Colon Neoplasms; Colon Cancer; Serrated Adenoma

Keywords

Endoscopic optical diagnosis

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Rate of polyps' recurrence at the end of the follow-up.

  5 years after the index resection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Virgen de las Nieves: lead
• Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental: collaborator

Study Sites (1)

"Virgen de las Nieves" University Hospital

Granada, 18014, Spain

Location

Related Publications (11)

• 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.

  PMID: 19523536 BACKGROUND

• 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.

  PMID: 16527698 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.

  PMID: 30848728 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.

  PMID: 21353837 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.

  PMID: 24639382 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.

  PMID: 23300139 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.

  PMID: 25753029 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.

  PMID: 29571175 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.

  PMID: 26191348 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.

  PMID: 27196576 BACKGROUND

• 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.

  PMID: 34988735 DERIVED

MeSH Terms

Conditions

Colonic Polyps; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Clara Heredia-Carrasco, MD

  'Virgen de las Nieves' University Hospital. Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastroenterology

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: December 22, 2019
• Primary Completion: December 1, 2021
• Study Completion: January 31, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)