Soft Coagulation for the Prevention of Adenoma Recurrence

Not Applicable

Completed

• Conditions: Colonic Adenomas

• Registration Number: NCT01789749
• Lead Sponsor: Professor Michael Bourke

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-28
• Study First Submitted QC: 2013-02-11
• Study First Posted: 2013-02-12
• Study Start: 2013-07
• Primary Completion: 2016-05-16
• Study Completion: 2016-12-16
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 455

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Endoscopic recurrence	4-6 months and 18 months	Presence of residual/recurrent adenoma at the EMR scar at endoscopic follow-up

Secondary Outcome Measures

Name	Time	Method
Perforation during EMR	During index procedure	Perforation during EMR
Post EMR bleeding	Post Index procedure	Bleeding after EMR requiring admission or repeat intervention
Readmission	After index procedure	Readmission after index procedure
Histologic recurrence	4-6 months and 18 months	Presence of residual/recurrent adenoma on biopsy of the endoscopic resection scar
En bloc resection	Index procedure	Rate of 'en bloc resection' (removing entire lesion in one snare) with histologically confirmed clear margins
Duration	Index procedure	Time required for EMR
Number of injections for hemostasis	Index procedure, if post EMR bleeding	Number of injections required for haemostasis
Location of bleeding vessels	Index procedure, if post EMR bleeding	Location of bleeding vessels
Delayed perforation	After index procedure	Delayed perforation requiring intervention or readmission
Snare resections	Index procedure	The number of snare resections needed to achieve complete clearance
Size/number of bleeding vessels	Index procedure, if post EMR bleeding	Size/number of bleeding vessels

Trial Locations

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