Soft Coagulation for the Prevention of Adenoma Recurrence

Study Overview
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Brief Summary
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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.

Official Title
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Soft Coagulation for the Prevention of Adenoma Recurrence After Endoscopic Mucosal Resection (EMR) of Large Sessile Colonic Polyps: A Multicentre, Randomized Trial.

Conditions
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Colonic Adenomas

Intervention / Treatment
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* Other: Snare Tip Soft Coagulation
* Other: No Snare Tip Soft Coagulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No Coagulation Arm<br>Patients do not receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect | Other: No Snare Tip Soft Coagulation<br> <br> |
| Experimental: Coagulation Arm<br>Patients to receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect | Other: Snare Tip Soft Coagulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic recurrence | Presence of residual/recurrent adenoma at the EMR scar at endoscopic follow-up | 4-6 months and 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic recurrence | Presence of residual/recurrent adenoma on biopsy of the endoscopic resection scar | 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 | Index procedure | 
| Snare resections | The number of snare resections needed to achieve complete clearance | Index procedure | 
| Duration | Time required for EMR | Index procedure | 
| Perforation during EMR | Perforation during EMR | During index procedure | 
| Post EMR bleeding | Bleeding after EMR requiring admission or repeat intervention | Post Index procedure | 
| Number of injections for hemostasis | Number of injections required for haemostasis | Index procedure, if post EMR bleeding | 
| Location of bleeding vessels | Location of bleeding vessels | Index procedure, if post EMR bleeding | 
| Size/number of bleeding vessels | Size/number of bleeding vessels | Index procedure, if post EMR bleeding | 
| Delayed perforation | Delayed perforation requiring intervention or readmission | After index procedure | 
| Readmission | Readmission after index procedure | After index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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snare tip soft coagulation, endoscopic mucosal resection, adenoma recurrence, adenoma, colonoscopy