The CARMA Technique Study

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colonic Polyp; Colonic Sessile Serrated Lesion
• Intervention / Treatment: Procedure: CARMA technique

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Huelsen, MD; Phone Number: +61 7 3176 2111; Email: alexander.huelsenkatz@health.qld.gov.au

Study Locations

• Australia
  • Queensland
    • Woolloongabba, Queensland, Australia, 4102
      • Recruiting
      • Princess Alexandra Hospital
      • Contact: Alexander Huelsen, MD; Phone Number: +61 7 3176 2111; Email: alexander.huelsenkatz@health.qld.gov.au
      • Principal Investigator: Alexander Huelsen
      • Sub-Investigator: Zaki Hamarneh
      • Sub-Investigator: Prabha Selvanathan
      • Sub-Investigator: Jennifer Borowsky
      • Sub-Investigator: Caroline Cooper

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CARMA Technique; All included participants undergo polyp resection using standard of care polypectomy techniques, followed by the CARMA technique	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of achieving a clear resection margin using the CARMA technique	Established during index procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity of the CARMA technique for residual polyp detection	Established during index procedure
Frequency of residual polyp without CARMA assessment	Established during index procedure
Incomplete resection rate with use of CARMA technique	Established during index procedure
Incomplete resection rate with use of the CARMA technique in polyps > 10mm with hot snare	Established during index procedure
Incomplete resection rate with use of the CARMA technique in polyps > 10mm with cold snare	Established during index procedure
Residual polyp rate after CARMA technique with hot snare	Established during index procedure
Residual polyp rate after CARMA technique with cold snare	Established during index procedure
Time required for application of the CARMA technique with < 10mm	Established during index procedure
Time required for application of the CARMA technique with > 10mm	Established during index procedure
Polyp recurrence rate for < 10mm polyps	Established during surveillance procedure (following national guidelines - between 6 months to 5 years)
Polyp recurrence rate for > 10mm polyps	Established during surveillance procedure (following national guidelines - between 6 months to 5 years)

Collaborators and Investigators

• Sponsor: Princess Alexandra Hospital, Brisbane, Australia
• Investigators: Principal Investigator: Alexander Huelsen, MD, Princess Alexandra Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): November 1, 2026

Study Registration Dates

• First Submitted: October 18, 2021
• First Submitted That Met QC Criteria: October 18, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: 75076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No