Diagnostic Accuracy of 3-dimensional Imaging Device on Polyps and Adenomas During Colonoscopy

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Polyps; Colorectal Adenomas
• Intervention / Treatment: Diagnostic test: endoscopic evaluation of colorectal polyps and adenomas using 2D imaging colonoscope; Diagnostic test: endoscopic evaluation of colorectal polyps and adenomas using 3D imaging colonoscope

• Study Type: Interventional
• Enrollment (Actual): 460
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital of Digestive Disease

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2D imaging arm; participants will undergo polypectomy (CSP, CFP, or EMR) using 2D imaging colonoscope	Diagnostic test: endoscopic evaluation of colorectal polyps and adenomas using 2D imaging colonoscope; endoscopic diagnostic evaluation of colorectal polyps and adenomas before polypectomy using 2D imaging colonoscope
Experimental: 3D imaging arm; participants will undergo polypectomy (CSP, CFP, or EMR) using 3D imaging colonoscope	Diagnostic test: endoscopic evaluation of colorectal polyps and adenomas using 3D imaging colonoscope; endoscopic diagnostic evaluation of colorectal polyps and adenomas before polypectomy using 3D imaging colonoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall diagnostic accuracy of endoscopic polyp classification	The overall proportion of correct classifications by endoscopy (JNET vs. JNET+3D) compared to the gold standard (pathology) at the lesion level, across all polyp types	1-7 days after polypectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The colonoscopy-relevant adverse events	aspiration pneumonia, perforation, bleeding, splenic injury/rupture, death, or others requiring hospitalization within 30 days after the colonoscopy	1-30 days after polypectomy
Diagnostic accuracy of endoscopic classification for advanced polyps	The overall proportion of correct classifications by endoscopy compared to the gold standard (pathology) in lesion level about advanced polyps Advanced polyp was defined as having a conventional adenoma with size ≥10 mm or with high-grade dysplasia, or a sessile serrated lesion with size ≥10 mm or with dysplasia.	1-7 days after polypectomy
Diagnostic accuracy of endoscopic classification for serrated lesions	The overall proportion of correct classifications by endoscopy (JNET vs. JNET+3D) compared to the gold standard (pathology) at the lesion level for serrated lesions	1-7 days after polypectomy
Diagnostic accuracy of endoscopic classification for identifying patients requiring surveillance	patients with complete removal of at least 1 adenoma ≥ 10 mm or with high grade dysplasia, or ≥ 5 adenomas, or any serrated polyp ≥ 10 mm or with dysplasia	1-7 days after polypectomy
Diagnostic characteristics (sensitivity, specificity, PPV, NPV, LR+, LR-) for advanced polyps	The following diagnostic accuracy measures will be calculated for endoscopic classification (JNET vs. JNET+3D) in detecting adenomas at the lesion level, using final pathology as the gold standard: Sensitivity Specificity Positive predictive value (PPV) Negative predictive value (NPV) Positive likelihood ratio (LR+) Negative likelihood ratio (LR-)	1-7 days after polypectomy

Collaborators and Investigators

• Sponsor: Xijing Hospital of Digestive Diseases
• Investigators: Principal Investigator: Zhiguo Liu, M.D, Xijing Hospital of Digestive Disease

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): January 31, 2026

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: colorectal polyps; colorectal adenomas; three dimension imaging device
• Additional Relevant MeSH Terms: Neoplasms; Pathological Conditions, Anatomical; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenoma; Polyps
• Other Study ID Numbers: KY20242178-F-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No