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.

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.