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CompletedNCT06922877Updated Sep 10, 2026

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

An interventional study of Optical diagnosis based on JNET classification with WASP features (no 3D assistance) and Optical diagnosis based on JNET classification with WASP features plus 3D imaging assistance in Colorectal Polyps and Colorectal Adenomas, sponsored by Xijing Hospital of Digestive Diseases. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Xijing Hospital of Digestive Diseases · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
458
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

02

Conditions studied

  • Colorectal Polyps
  • Colorectal Adenomas

Keywords

  • three dimension imaging device
  • colorectal polyps
  • colorectal adenomas
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In context

Lead sponsor

Xijing Hospital of Digestive Diseases is the lead sponsor of 80 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
458 participants (actual)

Study arms

  • 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)

  • 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

Interventions

  • Diagnostic testOptical 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.

  • Diagnostic testOptical 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1-7 days after polypectomy

Secondary outcomes

  1. 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.

    Time frame: During the endoscopic procedure, immediately after optical diagnosis

  2. 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.

    Time frame: 1-7 days after polypectomy

  3. 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.

    Time frame: 1-7 days after polypectomy

  4. 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).

    Time frame: 1-7 days after polypectomy

  5. The colonoscopy-relevant adverse events

    aspiration pneumonia, perforation, bleeding, splenic injury/rupture, death, or others requiring hospitalization within 30 days after the colonoscopy

    Time frame: 1-30 days after polypectomy

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Study locations

1 site
  • Xijing Hospital of Digestive Disease
    Xi'an, Shaanxi 710032, China
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References and documents

Individual participant data

Plan to share: Yes — 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.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06922877
Lead sponsor
Xijing Hospital of Digestive Diseases
Responsible party
Zhiguo Liu (associate professor, Xijing Hospital of Digestive Diseases) — Principal investigator
First posted
Apr 11, 2025
Start date
May 1, 2025
Primary completion
Mar 31, 2026
Completion
Apr 30, 2026
Last update
Sep 10, 2026

Study contacts

Zhiguo Liu, M.D
principal investigator · Xijing Hospital of Digestive DIsease

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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