Soft Coagulation for the Prevention of Adenoma Recurrence (SCAR)

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

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 Overview

• Status: Completed
• Conditions: Colonic Adenomas
• Intervention / Treatment: Other: No Snare Tip Soft Coagulation; Other: Snare Tip Soft Coagulation

• Study Type: Interventional
• Enrollment (Actual): 455
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Westmead Endoscopy Unit
  • Queensland
    • Brisbane, Queensland, Australia
      • Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia
      • Lyell McEwin Hospital
  • VA
    • Melbourne, VA, Australia
      • The Alfred Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Professor Michael Bourke
• Investigators: Principal Investigator: Michael Bourke, FRACP, MBBS, Western SLHD

Publications and helpful links

General Publications

• Klein A, Tate DJ, Jayasekeran V, Hourigan L, Singh R, Brown G, Bahin FF, Burgess N, Williams SJ, Lee E, Sidhu M, Byth K, Bourke MJ. Thermal Ablation of Mucosal Defect Margins Reduces Adenoma Recurrence After Colonic Endoscopic Mucosal Resection. Gastroenterology. 2019 Feb;156(3):604-613.e3. doi: 10.1053/j.gastro.2018.10.003. Epub 2018 Oct 6.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): May 16, 2016
• Study Completion (Actual): December 16, 2016

Study Registration Dates

• First Submitted: November 28, 2012
• First Submitted That Met QC Criteria: February 11, 2013
• First Posted (Estimate): February 12, 2013

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: colonoscopy; adenoma; endoscopic mucosal resection; snare tip soft coagulation; adenoma recurrence
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Adenoma; Recurrence
• Other Study ID Numbers: HREC/12/WMEAD/139; HREC2012/5/4.6 (3512) (Other Identifier: SydneyWAHS HREC - Westmead campus)