Clinical trial NCT05099432: The CARMA Technique Study
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colonic Polyp
Colonic Sessile Serrated Lesion
Lead sponsor: Princess Alexandra Hospital, Brisbane, Australia
Sponsor class: OTHER
First posted: 2021-10-29
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Rate of achieving a clear resection margin using the CARMA technique
timeFrame: Established during index procedure
Secondary outcomes:
measure: Sensitivity and specificity of the CARMA technique for residual polyp detection
timeFrame: Established during index procedure
measure: Frequency of residual polyp without CARMA assessment
timeFrame: Established during index procedure
measure: Incomplete resection rate with use of CARMA technique
timeFrame: Established during index procedure
measure: Incomplete resection rate with use of the CARMA technique in polyps > 10mm with hot snare
timeFrame: Established during index procedure
measure: Incomplete resection rate with use of the CARMA technique in polyps > 10mm with cold snare
timeFrame: Established during index procedure
measure: Residual polyp rate after CARMA technique with hot snare
timeFrame: Established during index procedure
measure: Residual polyp rate after CARMA technique with cold snare
timeFrame: Established during index procedure
measure: Time required for application of the CARMA technique with < 10mm
timeFrame: Established during index procedure
measure: Time required for application of the CARMA technique with > 10mm
timeFrame: Established during index procedure
measure: Polyp recurrence rate for < 10mm polyps
timeFrame: Established during surveillance procedure (following national guidelines - between 6 months to 5 years)
measure: Polyp recurrence rate for > 10mm polyps
timeFrame: Established during surveillance procedure (following national guidelines - between 6 months to 5 years)
Other outcomes:
Locations:
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
Study officials:
affiliation: Princess Alexandra Hospital
name: Alexander Huelsen, MD
role: PRINCIPAL_INVESTIGATOR
References: