Soft Coagulation for the Prevention of Adenoma Recurrence

Professor Michael Bourke455 enrolled

Overview

Recurrence after endoscopic mucosal resection of laterally spreading lesions (LSL) \>= 20mm in size occurs in approximately 20% of cases at surveillance colonoscopy. We aim to evaluate the efficacy of prophylactic adjuvant thermal ablation of the EMR mucosal defect margin in reducing adenoma recurrence following colonic EMR.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

455

Conditions

Colonic Adenomas

Interventions

Snare Tip Soft CoagulationOTHER

No Snare Tip Soft CoagulationOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Referred for removal of a colonic polyp \>= 20mm in size * Able to give informed consent to involvement in trial Exclusion Criteria: * Younger than 18 years of age * Highly dependant on medical care * Women who are pregnant or may be pregnant. * Taken clopidogrel within 7 days * Taken warfarin within 5 days * Had full therapeutic dose unfractionated heparin within 6 hours * Had full therapeutic dose low molecular weight heparin (LMWH) within 12 hours * Known clotting disorder * Previous attempt at EMR of the polyp referred for resection * Polyp located at the ileo-caecal valve, appendiceal orifice * Fully circumferential polyp * Incomplete snare resection of the polyp

Locations (4)

Westmead Endoscopy Unit

Westmead, New South Wales, Australia

Princess Alexandra Hospital

Brisbane, Queensland, Australia

Lyell McEwin Hospital

Adelaide, South Australia, Australia

The Alfred Hospital

Melbourne, VA, Australia

Outcomes

Primary Outcomes

Endoscopic recurrence

Presence of residual/recurrent adenoma at the EMR scar at endoscopic follow-up

Time frame: 4-6 months and 18 months

Secondary Outcomes

Histologic recurrence

Presence of residual/recurrent adenoma on biopsy of the endoscopic resection scar

Time frame: 4-6 months and 18 months

En bloc resection

Rate of 'en bloc resection' (removing entire lesion in one snare) with histologically confirmed clear margins

Time frame: Index procedure

Snare resections

The number of snare resections needed to achieve complete clearance

Time frame: Index procedure

Duration

Time required for EMR

Time frame: Index procedure

Perforation during EMR

Time frame: During index procedure

Post EMR bleeding

Bleeding after EMR requiring admission or repeat intervention

Time frame: Post Index procedure

Number of injections for hemostasis

Number of injections required for haemostasis

Time frame: Index procedure, if post EMR bleeding

Location of bleeding vessels

Data from ClinicalTrials.gov

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