Diagnostic Accuracy of 3-dimensional Imaging Device on Polyps and Adenomas During Colonoscopy

Xijing Hospital of Digestive Diseases

Status: Enrolling

Conditions: Colorectal Polyps; Colorectal Adenomas

Treatments: Diagnostic Test: endoscopic evaluation of colorectal polyps and adenomas using 3D imaging colonoscope; Diagnostic Test: endoscopic evaluation of colorectal polyps and adenomas using 2D imaging colonoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT06922877

KY20242178-F-1

Details and patient eligibility

About

The goal of this clinical trial is to learn if 3-dimensional (3D) imaging device works to correctly classify colon polyps and adenomas during colonoscopy to guide the selection of proper treatment procedures. 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 correct classification as well as size and depth evaluation of polyps and adenomas during colonoscopy using pathology as gold standard? What adverse events do participants experience during colonoscopy and polypectomy?

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 classification and evaluation accuracy.

Participants will:

Undertake colonoscopy examination and polypectomy 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged over 18 years;
• Endoscopically diagnosed with colorectal polyps;
• Signing the written informed consent.

Exclusion criteria

• 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 severe inflammatory bowel disease/toxic megacolon;
• Patients with polyposis syndromes (e.g., Peutz-Jeghers syndrome, Cronkhite-Canada syndrome, familial adenomatous polyposis [FAP], Lynch syndrome, etc.);
• 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, or advanced colorectal cancer;
• Patients with intestinal strictures of any cause;
• Cases requiring only endoscopic submucosal dissection (ESD);
• Pregnancy and lactation.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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450 participants in 2 patient groups

2D imaging arm

Active Comparator group

Description:

participants will undergo polypectomy (CSP, CFP, or EMR) using 2D imaging colonoscope

Treatment:

Diagnostic Test: endoscopic evaluation of colorectal polyps and adenomas using 2D imaging colonoscope

3D imaging arm

Experimental group

Description:

participants will undergo polypectomy (CSP, CFP, or EMR) using 3D imaging colonoscope

Treatment:

Diagnostic Test: endoscopic evaluation of colorectal polyps and adenomas using 3D imaging colonoscope