Image

Longterm Effectiveness of Artificial Intelligence-assisted Colonoscopy on Adenoma Recurrence

Recruiting
18 years of age
Both
Phase N/A

Powered by AI

Overview

We hypothesize that AI-assisted colonoscopy can reduce post-colonoscopy neoplasia incidence after 3 years, over standard colonoscopy. Moreover, this protective effect may allow surveillance intervals to be lengthened, by modifying long-term outcome of high-risk subgroup.

Description

Recently, rapid development in artificial intelligence (AI) and automatic computer-aided polyp detection (CADe) systems have revolutionized the medical field. Multiple clinical trials reported significant benefits in colorectal neoplasia detection with the use of CADe over standard colonoscopy. The overall ADR and number of adenomas detected per colonoscopy were consistently higher. The performance of CADe was consistent in different levels of endoscopist experience. With the promising data, position statements from World Endoscopy Organization (WEO) and European Society of Gastrointestinal Endoscopy (ESGE) have supported the acceptance and introduction of CADe into clinical practice. However, most clinical trials only demonstrated a net benefit in the detection of small-to-medium size, non-advanced adenomas. A recent large-scale randomized trial failed to show any difference in advanced neoplasia detection rate between CADe and control groups. Furthermore, a meta-analysis of 21 randomized trials showed that CADe only improved adenoma but not advanced adenoma detection. It remains questionable whether AI can overcome all pitfalls and challenges in standard colonoscopies.

One of the major concerns before universal implementation of AI-assisted colonoscopy is the lack of real-world long-term data on the clinical efficacy of PCCRC prevention. It remains uncertain whether the detection and removal of small non-advanced adenomas could be translated into absolute clinical benefit. On one hand, patients with more non-advanced adenomas would be classified into higher risk groups according to the US Multi-Society Task Force (USMSTF) guideline, leading to more intensive surveillance colonoscopies, heavier service burden and higher healthcare costs. On the other hand, a high-quality index colonoscopy with fewer missed lesions and low PCCRC risk, could allow patients and clinicians to have higher confidence in lengthening surveillance intervals, leading to an ultimate reduction in the service demand and expenditure in the long run. Unfortunately, most current literature only focused on short-term outcomes and did not address this unsolved problem. Therefore, a prospective real-world cohort to confirm the long-term effectiveness of AI-assisted colonoscopy is urgently warranted.

Between April 2021 and July 2022, our group completed a parallel-group, randomized controlled trial in Hong Kong. [ENDOAID-TRAIN study; NCT04838951] 856 subjects undergoing colonoscopies were randomized 1:1 to receive colonoscopies with CADe (ENDO-AID, Olympus Co., Japan) or standard colonoscopies (control). Our study proved that AI-assisted colonoscopies could increase the overall ADR, especially small-to-medium size adenomas. It remains questionable whether the increased detection and removal of these non-advanced adenomas can be translated into any sustained long-term benefit. The impact of this AI-driven intensive surveillance on general population and healthcare system is also largely unknown. In this research project, we aim to assess the long-term effectiveness of AI-assisted colonoscopy on adenoma recurrence and PCCRC prevention, by conducting a real-world, prospective study with longitudinal extension from a randomized trial.

Eligibility

Inclusion Criteria:

Subjects are eligible if:

        (i) They underwent randomization to receive colonoscopy with/without CADe in ENDOAID-TRAIN
        study [NCT04838951]; (ii) They are fit and willing to undergo surveillance colonoscopy at
        year 3; (iii) Written informed consent obtained.
        Exclusion Criteria:
        Subjects will be excluded from the study if they have any of the followings:
        (i) Incomplete colonoscopy during index procedure; (ii) Known residual colorectal neoplasia
        not removed (except hyperplastic polyps); (iii) Underwent unscheduled interval colonoscopy
        before year 3; (iv) Contraindications to surveillance colonoscopy at year 3; (v) Advanced
        comorbid (American Society of Anesthesiologists grade 4 or above); (vi) History of CRC,
        hereditary polyposis syndrome or inflammatory bowel disease; (vii) History of colectomy at
        any time point.

Study details

Screening Colonscopy

NCT06251700

Chinese University of Hong Kong

15 May 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.