The CARMA Technique Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorPrincess Alexandra Hospital, Brisbane, Australia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • CARMA technique

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: CARMA TechniqueExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of achieving a clear resection margin using the CARMA technique

Time frame
Established during index procedure

Secondary outcomes

1

Sensitivity and specificity of the CARMA technique for residual polyp detection

Time frame
Established during index procedure
2

Frequency of residual polyp without CARMA assessment

Time frame
Established during index procedure
3

Incomplete resection rate with use of CARMA technique

Time frame
Established during index procedure
4

Incomplete resection rate with use of the CARMA technique in polyps > 10mm with hot snare

Time frame
Established during index procedure

Other outcomes

Sponsors and contacts

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