Clinical trial NCT06922877: Diagnostic Accuracy of 3-dimensional Imaging Device on Polyps and Adenomas During Colonoscopy
Official title: Diagnostic Accuracy of 3-dimensional Imaging Device on Polyps and Adenomas During Colonoscopy: a Single-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Polyps
Colorectal Adenomas
Keywords: three dimension imaging device
colorectal polyps
colorectal adenomas
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


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.

Primary outcomes:
measure: endoscopic diagnostic accuracy of polyps and adenomas
timeFrame: 1-7 days after polypectomy
Secondary outcomes:
measure: Modified high-risk adenoma (mHRA) detection rate
timeFrame: 1-7 days after polypectomy
measure: Adenoma detection rate (ADR)
timeFrame: 1-7 days after polypectomy
measure: Polyp detection rate (PDR)
timeFrame: 1-7 days after polypectomy
measure: Clinically relevant serrated polyp detection rate
timeFrame: 1-7 days after polypectomy
measure: early colorectal cancer detection rate
timeFrame: 1-7 days after polypectomy
measure: the accuracy of the evaluation of invasion depth
timeFrame: 1-7 days after polypectomy
measure: the confidence of endoscopy diagnosis
timeFrame: during endoscopy diagnosis before polypectomy by the endoscopists
measure: the accuracy of lession size evaluation
timeFrame: 1-7 days after polypectomy
measure: The colonoscopy-relevant adverse events
timeFrame: 1-30 days after polypectomy
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital of Digestive Disease
state: Shaanxi
Study officials:
affiliation: Xijing Hospital of Digestive DIsease
name: Zhiguo Liu, M.D
role: PRINCIPAL_INVESTIGATOR
References: