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 |
| 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 |