search
Back to results

Soft Coagulation for the Prevention of Adenoma Recurrence (SCAR)

Primary Purpose

Colonic Adenomas

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Snare Tip Soft Coagulation
No Snare Tip Soft Coagulation
Sponsored by
Professor Michael Bourke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colonic Adenomas focused on measuring snare tip soft coagulation, endoscopic mucosal resection, adenoma recurrence, adenoma, colonoscopy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Westmead Endoscopy Unit
  • Princess Alexandra Hospital
  • Lyell McEwin Hospital
  • The Alfred Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

No Coagulation Arm

Coagulation Arm

Arm Description

Patients do not receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect

Patients to receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 28, 2012
Last Updated
March 22, 2021
Sponsor
Professor Michael Bourke
search

1. Study Identification

Unique Protocol Identification Number
NCT01789749
Brief Title
Soft Coagulation for the Prevention of Adenoma Recurrence
Acronym
SCAR
Official Title
Soft Coagulation for the Prevention of Adenoma Recurrence After Endoscopic Mucosal Resection (EMR) of Large Sessile Colonic Polyps: A Multicentre, Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
May 16, 2016 (Actual)
Study Completion Date
December 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Professor Michael Bourke

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Adenomas
Keywords
snare tip soft coagulation, endoscopic mucosal resection, adenoma recurrence, adenoma, colonoscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients were blinded to the treatment allocation. The endoscopists performing the index and surveillance procedures were not blinded to the treatment.
Allocation
Randomized
Enrollment
455 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Coagulation Arm
Arm Type
Active Comparator
Arm Description
Patients do not receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect
Arm Title
Coagulation Arm
Arm Type
Experimental
Arm Description
Patients to receive Snare Tip Soft Coagulation to the edge of the endoscopic resection defect
Intervention Type
Other
Intervention Name(s)
Snare Tip Soft Coagulation
Intervention Type
Other
Intervention Name(s)
No Snare Tip Soft Coagulation
Primary Outcome Measure Information:
Title
Endoscopic recurrence
Description
Presence of residual/recurrent adenoma at the EMR scar at endoscopic follow-up
Time Frame
4-6 months and 18 months
Secondary Outcome Measure Information:
Title
Histologic recurrence
Description
Presence of residual/recurrent adenoma on biopsy of the endoscopic resection scar
Time Frame
4-6 months and 18 months
Title
En bloc resection
Description
Rate of 'en bloc resection' (removing entire lesion in one snare) with histologically confirmed clear margins
Time Frame
Index procedure
Title
Snare resections
Description
The number of snare resections needed to achieve complete clearance
Time Frame
Index procedure
Title
Duration
Description
Time required for EMR
Time Frame
Index procedure
Title
Perforation during EMR
Description
Perforation during EMR
Time Frame
During index procedure
Title
Post EMR bleeding
Description
Bleeding after EMR requiring admission or repeat intervention
Time Frame
Post Index procedure
Title
Number of injections for hemostasis
Description
Number of injections required for haemostasis
Time Frame
Index procedure, if post EMR bleeding
Title
Location of bleeding vessels
Description
Location of bleeding vessels
Time Frame
Index procedure, if post EMR bleeding
Title
Size/number of bleeding vessels
Description
Size/number of bleeding vessels
Time Frame
Index procedure, if post EMR bleeding
Title
Delayed perforation
Description
Delayed perforation requiring intervention or readmission
Time Frame
After index procedure
Title
Readmission
Description
Readmission after index procedure
Time Frame
After index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bourke, FRACP, MBBS
Organizational Affiliation
Western SLHD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westmead Endoscopy Unit
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Lyell McEwin Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
VA
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
30296436
Citation
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.
Results Reference
derived

Learn more about this trial

Soft Coagulation for the Prevention of Adenoma Recurrence

We'll reach out to this number within 24 hrs