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Completed

NCT Number: NCT05013125

ENDO-AID Assisted Tandem Colonoscopy RCT

This study hypothesizes that more adenomas will be detected using the ENDO-AID assisted Colonoscopy compared to conventional colonoscopy.

A single-centre, randomized, same-day, back-to-back tandem colonoscopy trial comparing Adenoma Missed Rate and Adenoma Detection Rate in ENDO-AID assisted colonoscopy and conventional colonoscopy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

About this study

Colorectal cancer is the third common cancer in the world and the commonest cancer in Hong Kong. Most sporadic colorectal cancers arise from benign polyps via adenoma-carcinoma sequence or the serrated polyp-carcinoma sequence. There are reports of unexpectedly high risk of interval carcinomas, as high as up to 9%, raising concerns about the effectiveness of colonoscopy in preventing colorectal cancers. Different techniques have been described to improve the area of mucosa visualised but lesions may still be missed due to failure of identification by the endoscopist.

Computer Aided diagnosis (CAD) assisted colonoscopy is becoming increasingly popular to address human error. Deep learning technology has surpassed human learning and advancement in technology now allows real-time Artificial Intelligence to assist colonoscopists in polyp detection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18years or above
  • Referred to endoscopy unit for diagnostic or surveillance colonoscopy

Exclusion criteria

  • Familial history of Familial adenomatous polyposis / Hereditary non-polyposis colorectal cancer
  • Known history of inflammatory bowel disease
  • Known colitis or suspicion of colitis (inflammatory bowel disease, diverticulitis, infective colitis)
  • Emergency endoscopy of any nature (eg gastrointestinal bleeding, colonic decompression)
  • Previous incomplete colonoscopy (not including insufficient preparation) / difficult colonoscopy
  • Patients referred for a therapeutic procedure or assessment of a known non-resected lesion
  • Patients with known palliative colorectal malignancy
  • Patient with coagulopathy
  • Patient with colostomy
  • Patient with multiple co-morbidities (American Society of Anaesthesiologist >3)
  • Inability to give informed consent

Treatment and study plan

ENDO-AID CADe assisted Colonoscopy

Diagnostic Test

ENDO-AID is a dedicated endoscopy Computer-Aided Diagnosis (CADe) system where suspicious lesions are automatically detected and highlighted on the main monitor in real-time, alerting the endoscopist during the procedure.

Primary outcomes

  1. Adenoma missed rate

    Time frame: End of study, about 1 year

    To compare the adenoma missed rate (AMR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy. AMR is defined as the number of adenomas detected in the second pass colonoscopy divided by the total number of adenomas detected in both passes for the same patients.

Secondary outcomes

  1. Polyp missed rate

    Time frame: End of study, about 1 year

    To compare the Polyp missed rate (PMR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy. PMR is defined as the number of polyps detected in the second pass colonoscopy divided by the total number of polyps detected in both passes for the same patients.

  2. Adenoma detection rate

    Time frame: End of study, about 1 year

    To compare the Adenoma detection rate (ADR) between ENDO-AID assisted Colonoscopy and conventional colonoscopy for the first pass colonoscopy. ADR is defined as the proportion of patients with at least 1 adenoma detected in the first pass colonoscopy.

  3. Patient missed rate

    Time frame: End of study, about 1 year

    To compare the patient missed rate (PMR) between ENDO-AID assisted colonoscopy and conventional white light colonoscopy. PMR is defined as the number of patients in whom adenomas were detected for the first time during second pass colonoscopy divided by the number of patients with at least 1 adenoma detected.

  4. Number of polyps removed

    Time frame: End of study, about 1 year

    To compare the number of polyps removed between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy

  5. Baseline Parameters

    Time frame: End of study, about 1 year

    Baseline Parameters will be compared, including withdrawal time and Boston Bowel Preparation Scale in the first colonoscopy procedures

  6. Serious Adverse Events

    Time frame: At 30 days

    To compare the Serious Adverse Events between ENDO-AID assisted Colonoscopy and conventional white light colonoscopy

  7. Number of CAD assisted abnormality

    Time frame: End of study, about 1 year

    Number of abnormalities highlighted on ENDO-AID and actual number of abnormalities found macroscopically and histologically

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Assessment of Efficacy of ENDO-AID Assisted Colonoscopy in Adenoma Detection: a Single Centre Randomised Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2021
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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