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

Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications for Surveillance (Polyp Size Study)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Polyp
• Intervention / Treatment: Device: AccuMeasure

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 Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525GA
      • Radboud University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Accumeasure last; Optical polyp size assessment, followed by biopsy forceps and then AccuMeasure measurement	Device: AccuMeasure; intracolonoscopy measurement of polyps using a laser-based device; Other Names: laser-based polyp measurement
Other: AccuMeasure first; optical assessment, followed by AccuMeasure measurement and then biopsy forceps assisted assessment (2)	Device: AccuMeasure; intracolonoscopy measurement of polyps using a laser-based device; Other Names: laser-based polyp measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohens' Kappa coefficient	interobserver agreement between AccuMeasure and biopsy forceps assisted measurement	at colonoscopy

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Method of polyp removal	method of polyp removal, i.e., polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection	at colonscopy
BBPS	Boston bowel preparation scale score (BBPS), in which segmental scores of 0 are worst and scores of 3 are best (completely clean)	at colonoscopy

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: NYU Langone Health; Tel-Aviv Sourasky Medical Center; Bnai Zion Medical Center; Universitätsklinikum Hamburg-Eppendorf; Indiana University Health

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: August 3, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): January 4, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: colonoscopy; screening; surveillance
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: NL80961.091.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The dataset used during this study is available from the corresponding author upon reasonable request
• IPD Sharing Time Frame: 15y
• IPD Sharing Access Criteria: The dataset used during this study is available from the corresponding author upon reasonable request
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP); Clinical Study Report (CSR); Analytic Code

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