Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy

NCT06924489 | Not Yet Recruiting DMC

• 1 other identifier: KY20242132-F-1
• Study Type: interventional
• Target: 1,566
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colorectal Adenoma; Colorectal Polyps

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Adenoma detection rate (ADR)

  1-7 days after polypectomy

• Polyp detection rate (PDR)

  1-7 days after polypectomy

• Clinically relevant serrated polyp detection rate

  1-7 days after polypectomy

• Modified advanced adenoma detection rate

  1-7 days after polypectomy

• Advanced adenocarcinoma detection rate

  1-7 days after polypectomy

Study Arms (2)

2D imaging arm

ACTIVE COMPARATOR

participants will undergo colonoscopy examination using 2D imaging colonoscope

Procedure: Colonoscopy after bowel cleansing with 2D imaging device

3D imaging arm

EXPERIMENTAL

participants will undergo colonoscopy examination using 3D imaging colonoscope

Procedure: Colonoscopy after bowel cleansing with 3D imaging device

Interventions

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.

2D imaging arm

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.

3D imaging arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead
• Beijing Friendship Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator

Study Officials

• Zhiguo Liu, M.D

  Xijing Hospital of Digestive Disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhiguo Liu, M.D

CONTACT

86-29-84771535; liuzhiguo@fmmu.edu.cn

Jiaqiang Dong, M.D

CONTACT

dongjiaqiang1988@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 11, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share