Assessing the Agreement Between Endoscopic and Histopathological Diagnosis of Colorectal Sessile Serrated Lesions.

NCT06173297 | Completed

• 1 other identifier: AVAP-NG 1415
• Study Type: observational
• Target: 772
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study was to assess the degree of agreement between the endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions in adult patients undergoing colonoscopy in Hospital Sírio-Libanes. The main questions it aimed to answer were:

• The degree of agreement between endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions by calculating the Kappa Value of agreement.
• To establish the detection rate of sessile serrated lesions and adenomas in the Endoscopy Department at Hospital Sírio-Libanês.
• To evaluate the degree of agreement between endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions based on the resection method.
• To assess the accuracy, positive predictive value, and negative predictive value of endoscopic diagnosis of serrated lesions compared to anatomopathological diagnosis. The data were prospectively collected through a form specifically designed for this project, that was completed immediately after the examination by the performing colonoscopist. All patients enrolled in this study agreed to participate in it and signed an informed consent form prior to the colonoscopy.

Conditions

Sessile Serrated Adenoma; Colorectal Polyp; Adenoma Colon; Colorectal Cancer; Colonoscopy; Adenoma Detection Rate; Quality Indicator

Outcome Measures

Primary Outcomes (1)

• To assess the degree of agreement between the endoscopic and the anatomopathological diagnosis of sessile serrated colorectal lesions

  To evaluate concordance between colonoscopy diagnosis and anatomopathological diagnosis, both overall and according to the resection method employed, Cohen's Kappa coefficients and their respective 95% confidence intervals were calculated. These coefficients were then categorized based on Landis \& Koch's criteria (1977).

  2 years

Secondary Outcomes (3)

• To establish the detection rate of sessile serrated lesions and adenomas in the Endoscopy Department at Hospital Sírio-Libanês.

  2 years

• Evaluate the degree of agreement between endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions based on the resection method.

  2 years

• Assess the accuracy, positive predictive value, and negative predictive value of endoscopic diagnosis of serrated lesions compared to anatomopathological diagnosis.

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged over 18 undergoing colonoscopy at Hospital Sírio-Libanês in the Bela-Vista unit, São Paulo, Brazil, between June and August of 2020.

You may qualify if:

• Patients undergoing elective colonoscopy at Hospital Sírio-Libanês between February 2020 and August 2020.
• Age over 18 years.

You may not qualify if:

• Patients with inflammatory bowel disease (IBD)
• Patients diagnosed with hereditary polyposis or non-polyposis syndromes.
• Patients with a history of colorectal surgery.
• Patients previously diagnosed with colorectal cancer (CRC).

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead

Study Sites (1)

Hospital Sírio-Libanes

São Paulo, 01308-050, Brazil

Location

Related Publications (11)

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  PMID: 33538338 BACKGROUND

• Pan J, Xin L, Ma YF, Hu LH, Li ZS. Colonoscopy Reduces Colorectal Cancer Incidence and Mortality in Patients With Non-Malignant Findings: A Meta-Analysis. Am J Gastroenterol. 2016 Mar;111(3):355-65. doi: 10.1038/ajg.2015.418. Epub 2016 Jan 12.

  PMID: 26753884 BACKGROUND

• Kaminski MF, Robertson DJ, Senore C, Rex DK. Optimizing the Quality of Colorectal Cancer Screening Worldwide. Gastroenterology. 2020 Jan;158(2):404-417. doi: 10.1053/j.gastro.2019.11.026. Epub 2019 Nov 20.

  PMID: 31759062 BACKGROUND

• Wolf AMD, Fontham ETH, Church TR, Flowers CR, Guerra CE, LaMonte SJ, Etzioni R, McKenna MT, Oeffinger KC, Shih YT, Walter LC, Andrews KS, Brawley OW, Brooks D, Fedewa SA, Manassaram-Baptiste D, Siegel RL, Wender RC, Smith RA. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018 Jul;68(4):250-281. doi: 10.3322/caac.21457. Epub 2018 May 30.

  PMID: 29846947 BACKGROUND

• Brenner H, Hoffmeister M, Arndt V, Stegmaier C, Altenhofen L, Haug U. Protection from right- and left-sided colorectal neoplasms after colonoscopy: population-based study. J Natl Cancer Inst. 2010 Jan 20;102(2):89-95. doi: 10.1093/jnci/djp436. Epub 2009 Dec 30.

  PMID: 20042716 BACKGROUND

• Hassan C, Antonelli G, Dumonceau JM, Regula J, Bretthauer M, Chaussade S, Dekker E, Ferlitsch M, Gimeno-Garcia A, Jover R, Kalager M, Pellise M, Pox C, Ricciardiello L, Rutter M, Helsingen LM, Bleijenberg A, Senore C, van Hooft JE, Dinis-Ribeiro M, Quintero E. Post-polypectomy colonoscopy surveillance: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2020. Endoscopy. 2020 Aug;52(8):687-700. doi: 10.1055/a-1185-3109. Epub 2020 Jun 22.

  PMID: 32572858 BACKGROUND

• O'Brien MJ, Winawer SJ, Zauber AG, Gottlieb LS, Sternberg SS, Diaz B, Dickersin GR, Ewing S, Geller S, Kasimian D, et al. The National Polyp Study. Patient and polyp characteristics associated with high-grade dysplasia in colorectal adenomas. Gastroenterology. 1990 Feb;98(2):371-9.

  PMID: 2403953 BACKGROUND

• Mareth K, Gurm H, Madhoun MF. Endoscopic Recognition and Classification of Colorectal Polyps. Gastrointest Endosc Clin N Am. 2022 Apr;32(2):227-240. doi: 10.1016/j.giec.2021.12.003. Epub 2022 Feb 22.

  PMID: 35361333 BACKGROUND

• Kim JH, Kang GH. Evolving pathologic concepts of serrated lesions of the colorectum. J Pathol Transl Med. 2020 Jul;54(4):276-289. doi: 10.4132/jptm.2020.04.15. Epub 2020 Jun 26.

  PMID: 32580537 BACKGROUND

• Vennelaganti S, Cuatrecasas M, Vennalaganti P, Kennedy KF, Srinivasan S, Patil DT, Plesec T, Lanas A, Horndler C, Andraws N, Cherian R, Mathur S, Hassan C, Repici A, Klotz D, Musulen E, Risio M, Castells A, Gupta N, Sharma P. Interobserver Agreement Among Pathologists in the Differentiation of Sessile Serrated From Hyperplastic Polyps. Gastroenterology. 2021 Jan;160(1):452-454.e1. doi: 10.1053/j.gastro.2020.09.015. Epub 2020 Sep 18. No abstract available.

  PMID: 32950521 BACKGROUND

• Ahmad A, Moorghen M, Wilson A, Saunders BP. NBI International Colorectal Endoscopic-derived high-confidence optical diagnosis of small polyps compared with histology: understanding errors to improve diagnostic accuracy. Gastrointest Endosc. 2023 Jan;97(1):78-88. doi: 10.1016/j.gie.2022.08.032. Epub 2022 Aug 24.

  PMID: 36029884 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Daniela S Oliveira, Master

  Hospital Sírio-Libanês

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 15, 2023
• Study Start: February 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)