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NCT Number: NCT06922877

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

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.

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Key information

Conditions

Colorectal Polyps Colorectal Adenomas

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xijing Hospital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optical diagnosis based on JNET classification with WASP features (no 3D assistance)

Diagnostic Test

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.

Optical diagnosis based on JNET classification with WASP features plus 3D imaging assistance

Diagnostic Test

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.

Primary outcomes

  1. Overall diagnostic concordance of endoscopic polyp classification

    Time frame: 1-7 days after polypectomy

    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.

Secondary outcomes

  1. Diagnostic confidence

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

    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.

  2. Diagnostic concordance for adenomas and sessile serrated lesions (SSLs)

    Time frame: 1-7 days after polypectomy

    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.

  3. Diagnostic concordance for identifying patients requiring surveillance

    Time frame: 1-7 days after polypectomy

    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.

  4. Diagnostic characteristics (sensitivity, specificity, PPV, NPV) for adenomas and SSLs

    Time frame: 1-7 days after polypectomy

    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).

  5. The colonoscopy-relevant adverse events

    Time frame: 1-30 days after polypectomy

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

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2025
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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