Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy

N/ANot Yet RecruitingNCT06924489

Xijing Hospital of Digestive Diseases1,566 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

1,566

Conditions

Colorectal Adenoma Colorectal Polyps

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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