Menu
Recruiting NCT05099432

The CARMA Technique Study

No phase Interventional Colonic Polyp Colonic Sessile Serrated Lesion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CARMA technique.
Who it may be relevant to
Registry conditions: Colonic Polyp, Colonic Sessile Serrated Lesion. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Rate of achieving a clear resection margin using the CARMA technique [Time frame: Established during index procedure]
Secondary outcome measures (11)
  • Sensitivity and specificity of the CARMA technique for residual polyp detection [Time frame: Established during index procedure]
  • Frequency of residual polyp without CARMA assessment [Time frame: Established during index procedure]
  • Incomplete resection rate with use of CARMA technique [Time frame: Established during index procedure]
  • Incomplete resection rate with use of the CARMA technique in polyps > 10mm with hot snare [Time frame: Established during index procedure]
  • Incomplete resection rate with use of the CARMA technique in polyps > 10mm with cold snare [Time frame: Established during index procedure]
  • Residual polyp rate after CARMA technique with hot snare [Time frame: Established during index procedure]
  • Residual polyp rate after CARMA technique with cold snare [Time frame: Established during index procedure]
  • Time required for application of the CARMA technique with < 10mm [Time frame: Established during index procedure]
  • Time required for application of the CARMA technique with > 10mm [Time frame: Established during index procedure]
  • Polyp recurrence rate for < 10mm polyps [Time frame: Established during surveillance procedure (following national guidelines - between 6 months to 5 years)]
  • Polyp recurrence rate for > 10mm polyps [Time frame: Established during surveillance procedure (following national guidelines - between 6 months to 5 years)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Australia · 1 center
  • Princess Alexandra Hospital — Woolloongabba

Identifiers

NCT: NCT05099432 · 75076

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗