Computer-aided Detection During Screening Colonoscopy

Colorectal Cancer Clinical Trial

Official title:

Real-time Computer-aided Polyp/Adenoma Detection During Screening Colonoscopy: a Single-center Crossover Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05734820
• Other study ID #: IECED-01062023
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2020
• Est. completion date: September 1, 2024

Study information

• Verified date: September 2023
• Source: Instituto Ecuatoriano de Enfermedades Digestivas
• Contact: Carlos Robles-Medranda, MD FASGE
• Phone: +59342109180
• Email: carlosoakm[@]yahoo.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Nowadays, colonoscopy is considered the gold standard for the detection of lesions in the colorectal mucosa. However, around 25% of polyps may be missed during the conventional colonoscopy. Based on this, new technological tools aimed to improve the quality of the procedures, diminishing the technical and operator-related factors associated with the missed lesions. These tools use artificial intelligence (AI), a computer system able to perform human tasks after a previous training process from a large dataset. The DiscoveryTM AI-assisted polyp detector (Pentax Medical, Hoya Group, Tokyo, Japan) is a newly developed detection system based on AI. It was designed to alert and direct the attention to potential mucosal lesions. According to its remarkable features, it may increase the polyp and adenoma detection rates (PDR and ADR, respectively) and decrease the adenoma miss rate (AMR).

Based on the above, the investigators aim to assess the real-world effectiveness of the DiscoveryTM AI-assisted polyp detector system in clinical practice and compare the results between expert (seniors) and non-expert (juniors) endoscopists.

Description:

Colorectal cancer (CRC) is worldwide the second and third cancer-related cause of death in men and women, respectively. For the detection of lesions in the mucosa (premalignant and malignant), colonoscopy has been considered the gold standard. However, up to 25% of lesions can be missed during conventional colonoscopy. Some technical (i.e., bowel preparation) and operator-related (i.e., expertise, and fatigue) factors are related to these missing lesions.

During the rapid-growing technological era, new tools were launched to improve the quality and performance of colonoscopies. Through the assistance of artificial intelligence (AI) an identification of a pattern can be achieved after a previous training from a large dataset of images. The DiscoveryTM AI-assisted polyp detector (Pentax Medical, Hoya Group, Tokyo, Japan), is a computer-assisted polyp/adenoma detection system based on AI. It detects classic adenomas and flat lesions, distinguished features like mucus cap or rim of debris with the advantage of a real-time and simultaneous multiple polyp detection. It was developed to minimize the missed lesions increasing as a result the polyp detection rate (PDR) and the adenoma detection rate (ADR).

Lately, published data evaluating the AI-assisted polyp detectors has demonstrate high sensitivity, specificity, and interobserver agreement. Due to the importance of CRC diagnosis and prompt treatment, and taking advantage of the newly introduced DiscoveryTM AI system, the investigators aim to assess the real-world effectiveness of this AI-assisted polyp detector system in clinical practice and compare the results between expert (seniors) and non-expert (juniors) endoscopists.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 312
• Est. completion date: September 1, 2024
• Est. primary completion date: June 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 89 Years

Eligibility

Inclusion Criteria:

• Adults =45 years old

• Patients referred for screening colonoscopy

• Adequate bowel preparation, Boston Bowel Preparation Scale (BBPS) =8

• Patients who authorized for endoscopic approach.

Exclusion Criteria:

• Pregnancy

• Any clinical condition which makes endoscopy inviable.

• Patients with history of Colorectal Carcinoma.

• Patients with history of Inflammatory Bowel Disease (IBD)

• Inability to provide informed consent

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Polyp
• Polyps

Intervention

Diagnostic Test:
• HD- colonoscopy
HD-colonoscopy performed by an expert or non-expert endoscopist. All lesions will be recorded, assessed, and removed for histological analysis.
• HD-colonoscopy assisted by AI
HD-colonoscopy with AI-assisted polyp detector. New polyps detected by AI will be recorded, removed, and studied.

Locations

Country	Name	City	State
Ecuador	Instituto Ecuatoriano de Enfermedades Digestivas (IECED)	Guayaquil	Guayas

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Ecuatoriano de Enfermedades Digestivas

Country where clinical trial is conducted

Ecuador, 

References & Publications (5)

Corley DA, Jensen CD, Marks AR, Zhao WK, Lee JK, Doubeni CA, Zauber AG, de Boer J, Fireman BH, Schottinger JE, Quinn VP, Ghai NR, Levin TR, Quesenberry CP. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med. 2014 Apr 3;370(14):1298-306. doi: 10.1056/NEJMoa1309086. — View Citation

Gong D, Wu L, Zhang J, Mu G, Shen L, Liu J, Wang Z, Zhou W, An P, Huang X, Jiang X, Li Y, Wan X, Hu S, Chen Y, Hu X, Xu Y, Zhu X, Li S, Yao L, He X, Chen D, Huang L, Wei X, Wang X, Yu H. Detection of colorectal adenomas with a real-time computer-aided system (ENDOANGEL): a randomised controlled study. Lancet Gastroenterol Hepatol. 2020 Apr;5(4):352-361. doi: 10.1016/S2468-1253(19)30413-3. Epub 2020 Jan 22. Erratum In: Lancet Gastroenterol Hepatol. 2020 Apr;5(4):e3. — View Citation

Kroner PT, Engels MM, Glicksberg BS, Johnson KW, Mzaik O, van Hooft JE, Wallace MB, El-Serag HB, Krittanawong C. Artificial intelligence in gastroenterology: A state-of-the-art review. World J Gastroenterol. 2021 Oct 28;27(40):6794-6824. doi: 10.3748/wjg.v27.i40.6794. — View Citation

Parsa N, Byrne MF. Artificial intelligence for identification and characterization of colonic polyps. Ther Adv Gastrointest Endosc. 2021 Jun 29;14:26317745211014698. doi: 10.1177/26317745211014698. eCollection 2021 Jan-Dec. — View Citation

Wang P, Berzin TM, Glissen Brown JR, Bharadwaj S, Becq A, Xiao X, Liu P, Li L, Song Y, Zhang D, Li Y, Xu G, Tu M, Liu X. Real-time automatic detection system increases colonoscopic polyp and adenoma detection rates: a prospective randomised controlled study. Gut. 2019 Oct;68(10):1813-1819. doi: 10.1136/gutjnl-2018-317500. Epub 2019 Feb 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate (ADR)	The ADR will be determined by every new colonoscopy (second intervention) with at least one adenoma, histologically proven/NBI NICE classification.; Results will be compared between experts and non-experts endoscopists.	up to one month
Primary	Polyp detection rate (PDR)	The PDR will be determined by every new colonoscopy (second intervention) with at least one polyp.; Results will be compared between experts and non-experts endoscopists.	up to two hours
Primary	Diagnostic performance of AI-assisted polyp detector	The diagnostic performance of the AI-assisted system will be assessed by sensitivity, specificity, positive and negative predictive values (PPV and NPV) and observer agreement.	up to three years
Secondary	Adenoma Miss Rate (AMR)	The AMR will be determined by the total number of missed adenomas on initial examination. The diagnosis of adenoma will be made by NBI NICE classification or biopsy.	Up to one month