Clinical trial NCT06924489: Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy
Official title: Effect of 3-Dimensional Imaging Device on Advanced Adenoma Detection During Colonoscopy: A Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Adenoma
Colorectal Polyps
Lead sponsor: Xijing Hospital of Digestive Diseases
Sponsor class: OTHER
Collaborators: name: Beijing Friendship Hospital
name: Qilu Hospital of Shandong University
First posted: 2025-04-11
Enrollment: 1566
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: High-risk adenoma (HRA) detection rate
timeFrame: 1-7 days after polypectomy
Secondary outcomes:
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: Modified advanced adenoma detection rate
timeFrame: 1-7 days after polypectomy
measure: Advanced adenocarcinoma detection rate
timeFrame: 1-7 days after polypectomy
measure: The number of lesions per colonoscopy
timeFrame: 1-7 days after polypectomy
measure: Lesion detection rate in different location
timeFrame: 1-7 days after polypectomy
measure: Lesion detection rate in different size
timeFrame: 1-7 days after polypectomy
measure: Lesion detection rate in different type
timeFrame: 1-7 days after polypectomy
measure: Lesion detection rate by endoscopists of different experience
timeFrame: 1-7 days after polypectomy
measure: Cecal intubation time
timeFrame: immediately during the colonoscopy examination procedure
measure: Withdrawal time
timeFrame: immediately during the colonoscopy examination procedure
measure: The colonoscopy-relevant adverse events
timeFrame: 1-30 days after polypectomy
Other outcomes:
Locations:
Study officials:
affiliation: Xijing Hospital of Digestive Disease
name: Zhiguo Liu, M.D
role: PRINCIPAL_INVESTIGATOR
References: