Clinical trial NCT05489380: Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications for Surveillance
Official title: Optical Diagnosis Versus Laser Measurement of Polyps' Size During Colonoscopy and Implications for Surveillance (Polyp Size Study)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Colorectal Polyp
Keywords: screening
colonoscopy
surveillance
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Tel-Aviv Sourasky Medical Center
name: Erasmus Medical Center
name: Bnai Zion Medical Center
name: NYU Langone Health
name: Indiana University Health
First posted: 2022-08-05
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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).
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cohens' Kappa coefficient
timeFrame: at colonoscopy
Secondary outcomes:
measure: Number of Participants with adverse events up to 30 days post colonoscopy
timeFrame: 30 days post colonoscopy
measure: Absolute size differences
timeFrame: at colonoscopy
measure: Time for measurement
timeFrame: at colonoscopy
measure: Endoscopist advised surveillance interval
timeFrame: At colonoscopy
Other outcomes:
measure: Method of polyp removal
timeFrame: at colonscopy
measure: BBPS
timeFrame: at colonoscopy
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Nijmegen
country: Netherlands
facility: Radboud university medical center
state: Gelderland
Study officials:
References: