Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Colonic Sessile Serrated Polyps
CSP-EMR
1 other identifier
interventional
474
1 country
1
Brief Summary
Comparing the efficacy of cold snare polypectomy with endoscopic mucosal resection
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Jun 2016
Longer than P75 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
August 13, 2016
CompletedFirst Posted
Study publicly available on registry
November 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedJune 29, 2023
June 1, 2023
3.6 years
August 13, 2016
June 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants with residual or recurrent adenoma as assessed at surveillance endoscopy
4-6 months
Secondary Outcomes (3)
Number of participants with bleeding after the EMR procedure has finished as assessed by telephone interview at 2 weeks
2 weeks
Number of participants with residual or recurrent adenoma as assessed at admission or telephone interview at 2 weeks
2 weeks
Number of participants with pain after EMR as assessed by VAS score and telephone interview at 2 weeks
2 weeks
Study Arms (2)
Cold snare polypectomy
ACTIVE COMPARATORCold snare resection, if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm
Endoscopic mucosal resection
ACTIVE COMPARATOREndoscopic mucosal resection (EMR), if necessary, multi-piece to resect sessile serrated adenoma (SSA) 8-20mm
Interventions
Use of a polypectomy snare closed over a polyp without electrocautery
Use of injected chromogelofusine solution to raise a lesion prior to snare resection with electrocautery
Eligibility Criteria
You may qualify if:
- \- Patients able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent
- Patients referred to Westmead and Auburn Hospital Endoscopy Unit for a colonoscopy for all indications
- Age \> 18 years
- At least one SSP 8-20 mm beyond the rectosigmoid junction without any endoscopic features of malignancy
- At least one SSP 8-20 mm beyond the rectosigmoid junction that according to the proceduralist, can be removed safely using either CSP or EMR
You may not qualify if:
- Current use of antiplatelets (excluding aspirin) or anticoagulants which have not appropriately been interrupted according to the guidelines \[21\]
- Known coagulopathy
- Pregnancy
- If any doubt about the morphology of the polyp, the patient will be excluded from the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Westmead Hospital
Westmead, New South Wales, 2145, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor of Medicine and Director of Endoscopy
Study Record Dates
First Submitted
August 13, 2016
First Posted
November 17, 2016
Study Start
June 1, 2016
Primary Completion
January 1, 2020
Study Completion
August 1, 2022
Last Updated
June 29, 2023
Record last verified: 2023-06