Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Polyps; Colorectal Adenoma
• Intervention / Treatment: Procedure: Colonoscopy after bowel cleansing with 2D imaging device; Procedure: Colonoscopy after bowel cleansing with 3D imaging device

• Study Type: Interventional
• Enrollment (Estimated): 1566
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhiguo Liu, M.D; Phone Number: 86-29-84771535; Email: liuzhiguo@fmmu.edu.cn
• Study Contact Backup: Name: Jiaqiang Dong, M.D; Email: dongjiaqiang1988@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2D imaging arm; participants will undergo colonoscopy examination using 2D imaging colonoscope	Procedure: Colonoscopy after bowel cleansing with 2D imaging device; 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.
Experimental: 3D imaging arm; participants will undergo colonoscopy examination using 3D imaging colonoscope	Procedure: Colonoscopy after bowel cleansing with 3D imaging device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High-risk adenoma (HRA) detection rate	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	1-7 days after polypectomy

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xijing Hospital of Digestive Diseases
• Collaborators: Beijing Friendship Hospital; Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Zhiguo Liu, M.D, Xijing Hospital of Digestive Disease

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: KY20242132-F-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No