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

• Sponsor: Radboud University Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05489380
• Collaborator: NYU Langone Health (Other), Universitätsklinikum Hamburg-Eppendorf (Other), Indiana University Health (Other), Tel-Aviv Sourasky Medical Center (Other), Bnai Zion Medical Center (Other)
• Enrollment: 138
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 10.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Polyp	Device: AccuMeasure	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 138 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: As optical assessment of polyps has a high interobserver variability, the order of polyps' size measurement using biopsy forceps or AM will be randomized per patient. Therefore, this study consists of two arms: Optical polyp size assessment, followed by biopsy forceps and then AM measurement (1), and optical assessment, followed by AM measurement and then biopsy forceps assisted assessment (2) (Figure 1).As optical assessment of polyps has a high interobserver variability, the order of polyps' size measurement using biopsy forceps or AM will be randomized per patient. Therefore, this study consists of two arms: Optical polyp size assessment, followed by biopsy forceps and then AM measurement (1), and optical assessment, followed by AM measurement and then biopsy forceps assisted assessment (2) (Figure 1).
• Masking: Single (Outcomes Assessor)
• Masking Description: the endoscopist will remain blinded to the AccuMeasure measurement outcomes, to avoid a learning effect that could influence subsequent measurements. Even so, all pathologist assessments will be done independent of the study allocation.
• Primary Purpose: Screening
• Official Title: Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications for Surveillance (Polyp Size Study)
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Nov 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cohens' Kappa coefficient [at colonoscopy]

   interobserver agreement between AccuMeasure and biopsy forceps assisted measurement

Secondary Outcome Measures

1. Number of Participants with adverse events up to 30 days post colonoscopy [30 days post colonoscopy]

   Number of Participants with adverse events

2. Absolute size differences [at colonoscopy]

   Size differences for optical/biopsy forceps/AM assessment as compared to pathology size measurement;

3. Time for measurement [at colonoscopy]

   Time for measurement with AccuMeasure related to number of measurements performed

4. 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

Other Outcome Measures

1. Method of polyp removal [at colonscopy]

   method of polyp removal, i.e., polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection

2. BBPS [at colonoscopy]

   Boston bowel preparation scale score (BBPS), in which segmental scores of 0 are worst and scores of 3 are best (completely clean)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Radboud university medical center	Nijmegen	Gelderland	Netherlands	6525GA

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Radboud University Medical Center
• ClinicalTrials.gov Identifier: NCT05489380
• Other Study ID Numbers: NL80961.091.22
• First Posted: Aug 5, 2022
• Last Update Posted: Aug 10, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by Radboud University Medical Center: screening; colonoscopy; surveillance
• Additional relevant MeSH terms: Polyps

Study Results

No Results Posted as of Aug 10, 2022