Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy

Not Applicable

Not yet recruiting

• Conditions: Colorectal Adenoma; Colorectal Polyps

• Registration Number: NCT06924489
• Lead Sponsor: Xijing Hospital of Digestive Diseases

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Study Start: 2025-06-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1566

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
High-risk adenoma (HRA) detection rate	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 Outcome Measures

Name	Time	Method
Adenoma detection rate (ADR)	1-7 days after polypectomy	The number of participants with at least 1 adenoma divided by the total number of participants
Polyp detection rate (PDR)	1-7 days after polypectomy	The number of participants with at least 1 polyp divided by the total number of participants
Lesion detection rate in different size	1-7 days after polypectomy	Lesion (adenoma, polyp, clinically relevant serrated polyps) detection rate in different size (≤3mm, 3-10mm, \>10mm)
Lesion detection rate in different type	1-7 days after polypectomy	Lesion (adenoma, polyp, clinically relevant serrated polyps) detection rate in different type (Paris classification)
Lesion detection rate by endoscopists of different experience	1-7 days after polypectomy	Lesion (adenoma, polyp, clinically relevant serrated polyps) detection rate by endoscopists of different experience (senior or junior)
Cecal intubation time	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
Withdrawal time	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
The colonoscopy-relevant adverse events	1-30 days after polypectomy	Aspiration pneumonia, perforation, bleeding, splenic injury/rupture, death, or others requiring hospitalization within 30 days after the colonoscopy
Clinically relevant serrated polyp detection rate	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.
Modified advanced adenoma detection rate	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
Advanced adenocarcinoma detection rate	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
The number of lesions per colonoscopy	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
Lesion detection rate in different location	1-7 days after polypectomy	Lesion (adenoma, polyp, clinically relevant serrated polyps) detection rate in different location of colon and rectum