Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy

Xijing Hospital of Digestive Diseases

Status: Not yet enrolling

Conditions: Colorectal Adenoma; Colorectal Polyps

Treatments: Procedure: Colonoscopy after bowel cleansing with 3D imaging device; Procedure: Colonoscopy after bowel cleansing with 2D imaging device

Study type: Interventional

Funder types: Other

Identifiers

NCT06924489

KY20242132-F-1

Details and patient eligibility

About

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.

Enrollment: 1,566 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,566 participants in 2 patient groups

2D imaging arm

Active Comparator group

Description:

participants will undergo colonoscopy examination using 2D imaging colonoscope

Treatment:

Procedure: Colonoscopy after bowel cleansing with 2D imaging device

3D imaging arm

Experimental group

Description:

participants will undergo colonoscopy examination using 3D imaging colonoscope

Treatment:

Procedure: Colonoscopy after bowel cleansing with 3D imaging device