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NCT Number: NCT06924489

Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy

The goal of this clinical trial is to learn if 3-dimensional (3D) imaging device works to identify patients with high risk adenomas during colonoscopy to guide proper follow-up strategy. It will also learn about the safety of 3-dimensional (3D) imaging device. The main questions it aims to answer are:

Does 3-dimensional (3D) imaging device improve the identification of patients with high risk adenomas? What adverse events do participants experience during colonoscopy? Researchers will compare 3-dimensional (3D) imaging device to traditional 2-dimensional (2D) imaging device to see if 3-dimensional (3D) imaging device works to improve high risk adenoma identification.

Participants will:

Undertake colonoscopy examination using 3-dimensional (3D) imaging device or 2-dimensional (2D) imaging device. Be followed-up to 30 days to record potential colonoscopy-relevant adverse events.

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Key information

Conditions

Colorectal Adenoma Colorectal Polyps

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18-75 years;
  • Patients with indications for colonoscopy and receiving diagnostic colonoscopy, without history of inflammatory bowel disease, colorectal cancer, polypectomy or polyposis syndromes;
  • Signing the written informed consent;

Exclusion criteria

  • Patients with polyposis syndromes (e.g., Peutz-Jeghers syndrome, Cronkhite-Canada syndrome, familial adenomatous polyposis [FAP], Lynch syndrome, etc.);
  • Patients with a history of colorectal polypectomy and pathological diagnosed as adenoma;
  • Patients with a history of colorectal adenocarcinoma or alarming symptoms;
  • Patients with a history of inflammatory bowel disease;
  • Patients with mental illness or severe functional disorder who cannot cooperate with colonoscopy;
  • Patients with severe cardiopulmonary insufficiency;
  • Patients with severe coagulation disorders or high bleeding risk (platelets <50×10⁹/L, INR >1.5; discontinuation of antithrombotic drugs should follow the 2012 Japanese Guidelines for Gastroenterological Endoscopy in Patients Undergoing Antithrombotic Treatment and the2017 Appendix on Anticoagulants Including Direct Oral Anticoagulants;
  • Patients with severe electrolyte imbalances;
  • Patients with acute peritonitis or suspected intestinal perforation;
  • Patients with toxic megacolon;
  • Patients with stage 3 or higher hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
  • Patients with untreated severe abdominal hernia, intestinal obstruction;
  • Patients with intestinal strictures of any cause;
  • Pregnancy and lactation.

Treatment and study plan

Colonoscopy after bowel cleansing with 2D imaging device

Procedure

participants will undergo colonoscopy examination using 2D imaging colonoscope to detect potential adenomas or polyps. The classification of the detected lession will be determined by the edoscopic diagnosis based on the JNET classification system or by the pathological diagnosis with tissues from biopsy or polypectomy.

Colonoscopy after bowel cleansing with 3D imaging device

Procedure

participants will undergo colonoscopy examination using 3D imaging colonoscope to detect potential adenomas or polyps. The classification of the detected lession will be determined by the edoscopic diagnosis based on the JNET classification system or by the pathological diagnosis with tissues from biopsy or polypectomy.

Primary outcomes

  1. High-risk adenoma (HRA) detection rate

    Time frame: 1-7 days after polypectomy

    HRA were defined with one of the following features:1. diameter ≥10 mm or 2. (tubulo)villous adenomas or 3. with high-grade dysplasia or 4. sessile serrated lesions (SSLs) or 5. ≥ 3 adenomas. SSLs were defined as lesions with at least one crypt showing a characteristic sessile serrated lesion-type appearance.

    HRA detection rate is defined as the number of participants diagnosed with HRA divided by the total number of participants

Secondary outcomes

  1. Adenoma detection rate (ADR)

    Time frame: 1-7 days after polypectomy

    The number of participants with at least 1 adenoma divided by the total number of participants

  2. Polyp detection rate (PDR)

    Time frame: 1-7 days after polypectomy

    The number of participants with at least 1 polyp divided by the total number of participants

  3. Clinically relevant serrated polyp detection rate

    Time frame: 1-7 days after polypectomy

    Clinically relevant serrated polyps are defined as ≥10 mm serrated polyps (SPs, including hyperplastic polyps, SSLs, and traditional serrated adenomas) and >5 mm SPs in the proximal colon.

    Clinically relevant serrated polyp detection rate is defined as the number of participants with at least 1 clinically relevant serrated polyp divided by the total number of participants.

  4. Modified advanced adenoma detection rate

    Time frame: 1-7 days after polypectomy

    Modified advanced adenoma are defined with one of the following features:1. diameter ≥10 mm or 2. (tubulo)villous adenomas or 3. with high-grade dysplasia or 4. sessile serrated lesions (SSLs). SSLs were defined as lesions with at least one crypt showing a characteristic sessile serrated lesion-type appearance.

    Modified advanced adenoma detection rate is defined as the number of participants diagnosed with modified advanced adenoma divided by the total number of participants

  5. Advanced adenocarcinoma detection rate

    Time frame: 1-7 days after polypectomy

    Advanced adenocarcinoma is defined as adenocarcinoma with submucosal invasion more than 1000μm (SM2). Advanced adenocarcinoma detection rate is defined as the number of participants diagnosed with advanced adenocarcinoma divided by the total number of participants

  6. The number of lesions per colonoscopy

    Time frame: 1-7 days after polypectomy

    The number of lesions per colonoscopy was defined as the number of corresponding lesions (adenoma, polyp, clinically relevant serrated polyps, et al)divided by the total number of colonoscopies or participants

  7. Lesion detection rate in different location

    Time frame: 1-7 days after polypectomy

    Lesion (adenoma, polyp, clinically relevant serrated polyps) detection rate in different location of colon and rectum

  8. Lesion detection rate in different size

    Time frame: 1-7 days after polypectomy

    Lesion (adenoma, polyp, clinically relevant serrated polyps) detection rate in different size (≤3mm, 3-10mm, >10mm)

  9. Lesion detection rate in different type

    Time frame: 1-7 days after polypectomy

    Lesion (adenoma, polyp, clinically relevant serrated polyps) detection rate in different type (Paris classification)

  10. Lesion detection rate by endoscopists of different experience

    Time frame: 1-7 days after polypectomy

    Lesion (adenoma, polyp, clinically relevant serrated polyps) detection rate by endoscopists of different experience (senior or junior)

  11. Cecal intubation time

    Time frame: immediately during the colonoscopy examination procedure

    Cecal intubation time (CIT) is defined as the time from the insertion of the colonoscope tip into the anal verge until reaching the cecal base or cecal end

  12. Withdrawal time

    Time frame: immediately during the colonoscopy examination procedure

    Withdrawal time is defined as the time from reaching the cecal base or cecal end to the endoscope withdrawal to the anal verge, excluding the time of polypectomy

  13. The colonoscopy-relevant adverse events

    Time frame: 1-30 days after polypectomy

    Aspiration pneumonia, perforation, bleeding, splenic injury/rupture, death, or others requiring hospitalization within 30 days after the colonoscopy

Study contacts

Contact information is provided by the study sponsor or research team.

Jiaqiang Dong, M.D

CONTACT

[email protected]

zhiguo Liu, M.D

CONTACT

[email protected]

86-29-84771535

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Collaborators

  • Beijing Friendship Hospital
  • Qilu Hospital of Shandong University

Registry information

Official study title

Effect of 3-Dimensional Imaging Device on Advanced Adenoma Detection During Colonoscopy: A Multi-center Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2025
Registry last updated
Apr 11, 2025

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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