Optical Diagnosis With vs. Without Three-Dimensional Imaging for Small and Diminutive Colorectal Polyps

Optical Diagnosis With vs. Without Three-Dimensional Imaging for Small and Diminutive Colorectal Polyps: A Prospective Randomized Controlled Trial

This study investigated whether adding a three-dimensional (3D) imaging view during colonoscopy helps doctors classify small colon polyps more accurately than standard colonoscopy without 3D. Polyps are small growths in the colon that may develop into cancer over time. When doctors remove polyps, they often examine them closely during the procedure to judge how likely they are to be precancerous-a process called optical diagnosis.

In this study, two approaches to optical diagnosis were compared: diagnosis using standard colonoscopy without 3D, and diagnosis using the same colonoscopy with additional 3D imaging. Both groups used the same classification systems (JNET and WASP) to identify polyp type; the only difference was whether 3D imaging was used. The main question was whether adding 3D improves the agreement between the doctor's diagnosis during colonoscopy and the final laboratory diagnosis of the removed polyp. The study also collected safety information.

Participants were randomly assigned to one of the two groups, like flipping a coin. Regardless of group, all participants underwent an initial colonoscopy to detect polyps, a second colonoscopy to remove polyps and perform optical diagnosis, and a follow-up period of up to 30 days to monitor for side effects. The study included adults with at least one colon polyp smaller than 10 mm that did not require a more advanced type of removal called ESD.

Study Overview

• Status: Completed
• Conditions: Colorectal Polyps; Colorectal Adenomas
• Intervention / Treatment: Diagnostic test: Optical diagnosis based on JNET classification with WASP features (no 3D assistance); Diagnostic test: Optical diagnosis based on JNET classification with WASP features plus 3D imaging assistance

• Study Type: Interventional
• Enrollment (Actual): 458
• 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:

• Adults aged ≥18 years;
• Underwent non-3D white-light colonoscopy with at least one colorectal polyp identified;
• Endoscopically estimated polyp size <10 mm;
• No indication for endoscopic submucosal dissection (ESD);
• Scheduled for inpatient polypectomy;
• Provided written informed consent.

Exclusion Criteria:

• History of any polypectomy;
• History of colorectal surgery;
• Inflammatory bowel disease (Crohn's disease or ulcerative colitis);
• Hereditary polyposis syndromes;
• Concurrent colorectal cancer;
• Contraindications to colonoscopy (e.g., severe cardiopulmonary insufficiency);
• Coagulopathy or failure to discontinue antithrombotic agents;
• Inability to cooperate with procedures;
• Pregnancy or lactation;
• Refusal to participate or inability to give informed consent.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: non-3D group; Participants will undergo inpatient colonoscopy with polypectomy (CSP, CFP, or EMR) using standard high-definition colonoscopy. Optical diagnosis will be based on the JNET classification, with additional WASP features applied for JNET Type 1 lesions, without 3D assistance.	Diagnostic test: Optical diagnosis based on JNET classification with WASP features (no 3D assistance); Real-time optical diagnosis of colorectal polyps <10 mm before polypectomy, based on the JNET classification with additional WASP features for JNET Type 1 lesions, using standard high-definition colonoscopy without 3D assistance.
Experimental: 3D imaging arm; Participants will undergo inpatient colonoscopy with polypectomy (CSP, CFP, or EMR) using standard high-definition colonoscopy with additional 3D imaging assistance. Optical diagnosis will be based on the JNET classification, with additional WASP features applied for JNET Type 1 lesions, integrating 3D visualization.	Diagnostic test: Optical diagnosis based on JNET classification with WASP features plus 3D imaging assistance; Real-time optical diagnosis of colorectal polyps <10 mm before polypectomy, based on the JNET classification with additional WASP features for JNET Type 1 lesions, using standard high-definition colonoscopy with 3D imaging assistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall diagnostic concordance of endoscopic polyp classification	The overall proportion of correct classifications by endoscopy (3D vs. non-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 confidence	The proportion of lesions classified with high versus low diagnostic confidence by the endoscopist during real-time optical diagnosis. High confidence was defined as clear visualization of both vascular and surface patterns permitting a definitive JNET classification; low confidence was defined as suboptimal visualization or ambiguous features precluding a definitive classification.	During the endoscopic procedure, immediately after optical diagnosis
Diagnostic concordance for adenomas and sessile serrated lesions (SSLs)	The overall proportion of correct classifications by endoscopy compared with the gold standard (pathology) at the lesion level for adenomas and for sessile serrated lesions, respectively.	1-7 days after polypectomy
Diagnostic concordance for identifying patients requiring surveillance	The proportion of patients for whom the surveillance interval assigned by optical diagnosis matches the interval assigned by pathology, according to the 2020 ESGE guideline. Surveillance intervals were determined based on all resected polyps, including those >10 mm, reflecting real-world clinical practice.	1-7 days after polypectomy
Diagnostic characteristics (sensitivity, specificity, PPV, NPV) for adenomas and SSLs	Diagnostic performance measures for endoscopic classification (3D vs. non-3D) in detecting adenomas and sessile serrated lesions at the lesion level, using final pathology as the gold standard. Measures include sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV).	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): May 1, 2025
• Primary Completion (Actual): March 31, 2026
• Study Completion (Actual): April 30, 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): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 4, 2026
• Last Verified: April 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)?: YES
• IPD Plan Description: De-identified individual participant data that underlie the results reported in this article (text, tables, figures, and appendices) will be shared. The study protocol and statistical analysis plan will also be made available. Data will be available beginning 6 months and ending 5 years following article publication. Data will be shared with researchers who provide a methodologically sound proposal, for the purpose of achieving the aims in the approved proposal. Proposals should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement.

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