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

Colorectal Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05489380
• Other study ID #: NL80961.091.22
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: August 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: November 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Polyp
• Polyps

Intervention

Device:
• AccuMeasure
intracolonoscopy measurement of polyps using a laser-based device

Locations

Country	Name	City	State
Netherlands	Radboud university medical center	Nijmegen	Gelderland

Sponsors (6)

Lead Sponsor	Collaborator
Radboud University Medical Center	Bnai Zion Medical Center, Indiana University Health, NYU Langone Health, Tel-Aviv Sourasky Medical Center, Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Method of polyp removal	method of polyp removal, i.e., polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection	at colonscopy
Other	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
Primary	Cohens' Kappa coefficient	interobserver agreement between AccuMeasure and biopsy forceps assisted measurement	at colonoscopy
Secondary	Number of Participants with adverse events up to 30 days post colonoscopy	Number of Participants with adverse events	30 days post colonoscopy
Secondary	Absolute size differences	Size differences for optical/biopsy forceps/AM assessment as compared to pathology size measurement;	at colonoscopy
Secondary	Time for measurement	Time for measurement with AccuMeasure related to number of measurements performed	at colonoscopy
Secondary	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