The CARMA Technique Study

NCT05099432 | Recruiting

• 1 other identifier: 75076
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colonic Polyp; Colonic Sessile Serrated Lesion

Outcome Measures

Primary Outcomes (1)

• Rate of achieving a clear resection margin using the CARMA technique

  Established during index procedure

Secondary Outcomes (11)

• 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

Study Arms (1)

CARMA Technique

EXPERIMENTAL

All included participants undergo polyp resection using standard of care polypectomy techniques, followed by the CARMA technique

Procedure: CARMA technique

Interventions

CARMA technique PROCEDURE

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.

CARMA Technique

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Princess Alexandra Hospital, Brisbane, Australia: lead

Study Sites (1)

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Huelsen, MD

  Princess Alexandra Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander Huelsen, MD

CONTACT

+61 7 3176 2111; alexander.huelsenkatz@health.qld.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Gastroenterologist, Principal Investigator

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: October 29, 2021
• Study Start: November 1, 2021
• Primary Completion: May 1, 2023
• Study Completion (Estimated): November 1, 2026
• Last Updated: November 15, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)