Status:
COMPLETED
Hybrid Versus Non-Hybrid Endoscopic Submucosal Dissection for Colorectal Polyps (SHORT-ESD)
Lead Sponsor:
AdventHealth
Conditions:
Colorectal Lesions
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This proposed trial will randomize 60 patients with a ≥20 mm large colorectal polyp to either undergo hybrid or non-hybrid ESD. For the primary comparison (hybrid vs non-hybrid ESD), the primary outco...
Detailed Description
Endoscopic submucosal dissection (ESD) permits the en-bloc resection of colorectal lesions irrespective of size. En-bloc resection, as opposed to piecemeal endoscopic mucosal resection (EMR) of colore...
Eligibility Criteria
Inclusion
- Any patient ≥18 years
- Ability to provide informed consent
- Patient scheduled to undergo colonoscopy with endoscopic resection of colorectal polyps
- Non-pedunculated polyps measuring ≥20 mm in lateral diameter by endoscopic estimation
Exclusion
- Age \< 18 years
- Inability to provide informed consent
- Pedunculated polyps (as defined by Paris classification type Ip)8
- Lesions \< 20 mm in lateral diameter
- Suspected adenocarcinoma with deep submucosal invasion (e.g. Paris III morphology, Kudo type Vn pit pattern)4,13
- Previously attempted incomplete endoscopic resection (EMR) of the lesion
- Uncorrected coagulopathy defined as an elevated INR ≥ 1.5 and/or platelet count \< 50,000
- Any standard contraindication to anesthesia and/or colonoscopy
- Pregnancy or lactating women
Key Trial Info
Start Date :
May 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2024
Estimated Enrollment :
247 Patients enrolled
Trial Details
Trial ID
NCT05347446
Start Date
May 9 2022
End Date
December 19 2024
Last Update
January 15 2025
Active Locations (5)
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1
University of Florida
Gainesville, Florida, United States, 32611
2
AdventHealth Orlando
Orlando, Florida, United States, 32803
3
Parkview
Fort Wayne, Indiana, United States, 46845
4
Baylor College of Medicine
Houston, Texas, United States, 77030