Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications for Surveillance

Not Applicable

• Conditions: Colorectal Polyp
• Interventions: Device: AccuMeasure

• Registration Number: NCT05489380
• Lead Sponsor: Radboud University Medical Center

Brief Summary

Recent updates of the guidelines on polyp surveillance of the American Society of Gastrointestinal Endoscopy (ASGE) and European Society of Gastrointestinal Endoscopy (ESGE) increasingly focus on size of polyps as an important indicator of malignant transformation to colorectal cancer (CRC). However, the interobserver variability in polyp size assessment between optical diagnosis of endoscopists and pathologists is considerable. This may lead to incorrect surveillance intervals in patients at risk for developing colorectal cancer, which may increase the risk of post-colonoscopy CRC (PCCRC). This study aims to assess the precision of a new laser-based measurement system (AccuMeasure, VTM Technologies Ltd.) for polyps during colonoscopy.

Detailed Description

Objective: The main objective is to compare the precision of polyp size measurement by AccuMeasure to biopsy forceps assisted measurement. Secondary objectives are to assess: Time needed for measurement and learning curve, endoscopists advised surveillance intervals based on both measurement methods, and safety.

Study design: Multicenter, randomized, parallel group, endoscopist blinded study, including the measurement of 138 polyps during standard colonoscopy. With a polyp detection rate of approximately 40%1, this results in up to 345 patients/colonoscopies to be included. Enrollment will conclude once 138 polyps are included in the study.

Study population: All adult patients with screening or surveillance colonoscopies will be asked for informed consent. Polyps smaller than 25mm found during colonoscopy are considered eligible for inclusion. Up to 3 polyps per patient can be included in this study.

Intervention: Optical assessment will be performed upon identification of the polyp. Then, measurement with AccuMeasure and biopsy forceps will be performed in a randomized order. The endoscopist will remain blinded to the AccuMeasure measurement outcomes, to avoid a learning effect that could influence subsequent measurements.

Study Timeline

• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-05
• Study Start: 2023-06-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• • Adult patients (>18 years)

  • Scheduled for screening, surveillance, or diagnostic colonoscopy
  • Polyps of all forms ≤ 25mm as assessed by the endoscopist

Exclusion Criteria

• • Therapeutic colonoscopy;

  • Inflammatory bowel disease (IBD);
  • American Society of Anesthesiologists (ASA) score of >3;
  • Inadequately corrected anticoagulation disorder or anticoagulation medication use;
  • Inability to provide informed consent;
  • Inadequate bowel preparation (Boston bowel preparation scale score [BBPS] <2 per segment);
  • No polyps identified during colonoscopy or only small (<5mm) hyperplastic rectal polyps;
  • Intraprocedural complications, not caused by the study device.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AccuMeasure first	AccuMeasure	optical assessment, followed by AccuMeasure measurement and then biopsy forceps assisted assessment (2)
Accumeasure last	AccuMeasure	Optical polyp size assessment, followed by biopsy forceps and then AccuMeasure measurement

Primary Outcome Measures

Name	Time	Method
Cohens' Kappa coefficient	at colonoscopy	interobserver agreement between AccuMeasure and biopsy forceps assisted measurement

Secondary Outcome Measures

Name	Time	Method
Number of Participants with adverse events up to 30 days post colonoscopy	30 days post colonoscopy	Number of Participants with adverse events
Absolute size differences	at colonoscopy	Size differences for optical/biopsy forceps/AM assessment as compared to pathology size measurement;
Time for measurement	at colonoscopy	Time for measurement with AccuMeasure related to number of measurements performed
Endoscopist advised surveillance interval	At colonoscopy	Endoscopist advised surveillance interval based on optical assessment during colonoscopy, on measurement with an open biopsy forceps, and on measurement with AccuMeasure

Trial Locations

Locations (3)

Indiana University Hospital; 🇺🇸 Indianapolis, Indiana, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

Radboud university medical center; 🇳🇱 Nijmegen, Gelderland, Netherlands