The CARMA Technique Study

Colonic Polyp Clinical Trial

Official title:

The Cap-Assisted Resection Margin Assessment (CARMA) Technique After Polyp Resection: a Prospective Feasibility Study of a "Novel" Approach to Reduce Polyp Recurrence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05099432
• Other study ID #: 75076
• Status: Recruiting
• Phase: N/A
• Start date: November 2021
• Est. completion date: November 2026

Study information

• Verified date: November 2021
• Source: Princess Alexandra Hospital, Brisbane, Australia
• Contact: Alexander Huelsen, MD
• Phone: +61 7 3176 2111
• Email: alexander.huelsenkatz[@]health.qld.gov.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Colonoscopic removal of polyps is an important and well-established tool in the prevention of colorectal cancers. However, high polyp recurrence rates after endoscopic resection, with resultant development of interval cancers, remains a problem; this most commonly stems from unrecognised incomplete polyp resection. Thus, a standardised endoscopic technique is needed that will allow endoscopists to consistently achieve a clear margin of resection. The investigators believe the Cap Assisted Resection Margin Assessment (CARMA) technique will address this problem. This novel technique focuses on a standardised assessment of the resection margin after endoscopic polypectomy utilising available standard high-definition video endoscopes with imaging features including narrow band imaging (NBI) and magnification endoscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: November 2026
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Patients with colonic polyps will be considered following below criteria

Inclusion Criteria:

• any polypectomy (though only a maximum of two polyps from one individual participant)

Exclusion Criteria:

• polyps less than 10mm which were resected under endoscopic view with a definite > 1mm clear margin
• scar site recurrence polyps
• polyps with endoscopic evidence of invasion
• pedunculated polyps
• pseudopolyps
• participants who will not be available for follow up endoscopy

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Polyps

Intervention

Procedure:
• CARMA technique
Once standard polyp resection and assessment of the polypectomy site without magnification is completed, the CARMA technique will be applied. This will involve an assessment of the entire polypectomy margin using cap assisted magnification endoscopy with the ability to also use NBI (at the endoscopist's discretion) and documentation of any residual polyp noted.

Locations

Country	Name	City	State
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Princess Alexandra Hospital, Brisbane, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of achieving a clear resection margin using the CARMA technique		Established during index procedure
Secondary	Sensitivity and specificity of the CARMA technique for residual polyp detection		Established during index procedure
Secondary	Frequency of residual polyp without CARMA assessment		Established during index procedure
Secondary	Incomplete resection rate with use of CARMA technique		Established during index procedure
Secondary	Incomplete resection rate with use of the CARMA technique in polyps > 10mm with hot snare		Established during index procedure
Secondary	Incomplete resection rate with use of the CARMA technique in polyps > 10mm with cold snare		Established during index procedure
Secondary	Residual polyp rate after CARMA technique with hot snare		Established during index procedure
Secondary	Residual polyp rate after CARMA technique with cold snare		Established during index procedure
Secondary	Time required for application of the CARMA technique with < 10mm		Established during index procedure
Secondary	Time required for application of the CARMA technique with > 10mm		Established during index procedure
Secondary	Polyp recurrence rate for < 10mm polyps		Established during surveillance procedure (following national guidelines - between 6 months to 5 years)
Secondary	Polyp recurrence rate for > 10mm polyps		Established during surveillance procedure (following national guidelines - between 6 months to 5 years)