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Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)

Studies

Study First Submitted Date 2021-09-02
Study First Posted Date 2021-09-13
Last Update Posted Date 2023-06-29
Start Month Year November 1, 2023
Primary Completion Month Year October 1, 2028
Verification Month Year June 2023
Verification Date 2023-06-30
Last Update Posted Date 2023-06-29

Detailed Descriptions

Sequence: 20558502
Description Rationale: Conventional EMR is well-established for the resection of lateral-spreading adenomas and has been shown to be highly efficacious with adjuvant STSC. Cauterisation-related complications occur relatively frequently and while endoscopically treatable, still carry morbidity not seen in current cold snare polypectomy data. Cold snare polypectomy has an excellent safety profile for smaller polyps, without cauterisation-related adverse events. Limited data on cold EMR for large adenomatous laterally-spreading lesions shows minimal complications. Efficacy, however, is yet to be evaluated in prospective randomised trials. Observational data demonstrates recurrence rates exceeding conventional EMR. Since STSC causes significant reduction in recurrence in conventional EMR, the safety and efficacy of this adjuvant technique, when compared to isolated cold snare EMR, has theoretical advantages in both safety and efficacy. The safety and efficacy of these two techniques will therefore be compared in a randomised controlled trial. Hypothesis: Cold snare EMR of 15-40mm lateral-spreading adenomas with adjuvant STSC is expected to be superior regarding complete resection and adenoma recurrence rates as compared to cold snare EMR.

Facilities

Sequence: 198482324
Name Westmead Endoscopy Unit
City Westmead
State New South Wales
Zip 2145
Country Australia

Conditions

Sequence: 51751842 Sequence: 51751843 Sequence: 51751844
Name Colorectal Polyp Name Colon Adenoma Name Colon Cancer
Downcase Name colorectal polyp Downcase Name colon adenoma Downcase Name colon cancer

Id Information

Sequence: 39823757
Id Source org_study_id
Id Value ETH11029

Countries

Sequence: 42223092
Name Australia
Removed False

Design Groups

Sequence: 55173100 Sequence: 55173101
Group Type Experimental Group Type Active Comparator
Title Cold EMR with adjuvant STSC to margins Title Cold EMR
Description Standard cold EMR technique with adjuvant snare tip soft coagulation to defect margins Description Standard Cold EMR resection technique

Interventions

Sequence: 52073385 Sequence: 52073386
Intervention Type Procedure Intervention Type Procedure
Name Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation Name Cold Snare Endoscopic Mucosal Resection
Description Use of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare. Following this defect margins are treated with electrocautery to create a rim of ablated tissue. Description Use of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare.

Keywords

Sequence: 79180159 Sequence: 79180160 Sequence: 79180161 Sequence: 79180162
Name Colonoscopy Name Polypectomy Name Adenoma Name Colorectal Cancer
Downcase Name colonoscopy Downcase Name polypectomy Downcase Name adenoma Downcase Name colorectal cancer

Design Outcomes

Sequence: 176024552 Sequence: 176024553 Sequence: 176024554
Outcome Type primary Outcome Type primary Outcome Type secondary
Measure Complete resection rate (CRR) Measure Adenoma recurrence rate (ARR) Measure Intra-procedural and post-procedural complication rates
Time Frame 1 day Time Frame 4-6 months Time Frame 30 days
Description Determined by endoscopic assessment (no visible residual adenoma) and histological assessment (biopsies of resection margin) Description ARR at first surveillance colonoscopy (SC1) as determined by endoscopic assessment (no visible recurrent adenoma) and histological assessment (scar biopsies) Description Intraprocedural bleeding, clinically significant post-polypectomy bleeding, deep mural injury, post polypectomy coagulation syndrome

Browse Conditions

Sequence: 191796391 Sequence: 191796392 Sequence: 191796393 Sequence: 191796394
Mesh Term Adenoma Mesh Term Neoplasms Mesh Term Neoplasms, Glandular and Epithelial Mesh Term Neoplasms by Histologic Type
Downcase Mesh Term adenoma Downcase Mesh Term neoplasms Downcase Mesh Term neoplasms, glandular and epithelial Downcase Mesh Term neoplasms by histologic type
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 47929565
Agency Class OTHER
Lead Or Collaborator lead
Name Western Sydney Local Health District

Overall Officials

Sequence: 29040167
Role Principal Investigator
Name Michael Bourke, MBBS
Affiliation Westmead Hospital (WSLHD)

Central Contacts

Sequence: 11924654
Contact Type primary
Name Kathleen Goodrick
Phone 88905555
Email Kathleen.goodrick@health.nsw.gov.au
Role Contact

Design Group Interventions

Sequence: 67640414 Sequence: 67640415
Design Group Id 55173100 Design Group Id 55173101
Intervention Id 52073385 Intervention Id 52073386

Eligibilities

Sequence: 30520460
Gender All
Minimum Age 18 Years
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria: Any patient undergoing colonoscopy who is older than 18 years of age, has a written consent for trial participation and has at least one laterally spreading lesion meeting the following description: Localisation in the colon or rectum Benign adenomatous surface features (Kudo III / IV, Japan NBI Expert Team (JNET) 2a) Granular or non-granular topography Paris classification 0-IIa/IIb +/- Is If present, sessile component may be no greater than 10mm in size. Polyp size ranging from 15 to 40mm Exclusion Criteria: Current use of antiplatelet (excluding aspirin) or anticoagulants which have not appropriately been interrupted according to the guidelines. Known bleeding disorder or coagulopathy. Pregnancy History of inflammatory bowel disease Previously attempted or otherwise non-lifting lesions Endoscopic features suggestive of submucosal invasion (Kudo Vi/n, JNET 2b / 3) or concurrent colorectal cancer Lesions involving the ileocaecal valve (ICV), appendiceal oriface or anorectal junction (ARJ)
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254078505
Number Of Facilities 1
Registered In Calendar Year 2021
Were Results Reported False
Has Us Facility False
Has Single Facility True
Minimum Age Num 18
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 1

Designs

Sequence: 30269476
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking Single
Masking Description Blinding
Intervention Model Description Randomised Controlled Trial
Outcomes Assessor Masked True

Responsible Parties

Sequence: 28649631
Responsible Party Type Principal Investigator
Name Professor Michael Bourke
Title Professor
Affiliation Western Sydney Local Health District