Using 3D imaging to improve colon polyp and adenoma classification during colonoscopy

Diagnostic Accuracy of 3-dimensional Imaging Device on Polyps and Adenomas During Colonoscopy: a Single-center Randomized Controlled Trial

This study is testing if a new 3D imaging device can help doctors better identify and understand colon polyps during colonoscopy compared to the usual 2D imaging.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xijing Hospital of Digestive Diseases (Academic / other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT06922877 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a 3-dimensional (3D) imaging device in accurately classifying colorectal polyps and adenomas during colonoscopy. Participants will undergo colonoscopy procedures using either the 3D imaging device or a traditional 2-dimensional (2D) imaging device, with the goal of determining if the 3D device enhances classification accuracy and evaluation of polyp size and depth. The study will also assess the safety of the 3D imaging device by monitoring any adverse events that occur during the procedures. Follow-up will occur for 30 days post-procedure to track any potential complications.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who have been endoscopically diagnosed with colorectal polyps.

Not a fit: Patients with severe cardiopulmonary insufficiency or those with certain severe medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses and treatment decisions for patients with colorectal polyps and adenomas.

How similar studies have performed: While the use of 3D imaging in medical diagnostics is promising, this specific approach to colorectal polyp classification is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Xi'an, Shaanxi

• Xijing Hospital of Digestive Disease — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Principal investigator: Zhiguo Liu, M.D — Xijing Hospital of Digestive DIsease
• Study coordinator: Zhiguo Liu, M.D

Conditions Colorectal Polyps; Colorectal Adenomas; three dimension imaging device; colorectal polyps; colorectal adenomas