Cold Snare Endoscopic Mucosal Resection (C-EMR) Versus Hot Snare Endoscopic Mucosal Resection (H-EMR) for Large Colorectal Polyps (10-20 mm)
NCT ID: NCT06180798
Last Updated: 2024-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
330 participants
INTERVENTIONAL
2024-01-10
2024-12-30
Brief Summary
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DESIGN : A Randomised interventional study. Sample size: 330
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Detailed Description
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* In Both groups (a mixture of saline and blue dye will be injected beneath the surface layer,and then a snare(is a ring shaped device used to cut polyp after surrounding it- like a rubber band ) will be used to remove tissue without using heat in Cold Endoscopic mucosal resection group and using electrosurgical unit (to control bleeding and to rapidly dissect soft tissue in surgery) by EndoCut Q mode (ensures safe and effective removal of large lesions in particular large polyps) in Hot Endoscopic mucosal resection group.
* After polypectomy (the surgical removal of a polyp) the area is inspected for residual polyp (presence of any type of tissue) using NBI (Narrow band imaging) and if present, will be CUT OFF.
* A Standard snare ( snare is a ring shaped device used to cut polyp after surrounding it- like a rubber band) is used to cut the polyps
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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cold snare endoscopic mucosal resection (C-EMR)
All procedures will be performed by experienced endoscopists (\>3 years of experience/\>1000 polypectomies) with the patient in the left lateral position under propofol sedation.submucosal injection of saline mixed with methylene blue will be used (no epinephrine) followed by resection using snare without using electrocautery in C-EMR group.The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used.After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps.
cold snare endoscopic mucosal resection (C-EMR)
All procedures will be performed by experienced endoscopists (\>3 years of experience/\>1000 polypectomies) with the patient in the left lateral position under propofol sedation.
The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used .
submucosal injection of saline mixed with methylene blue will be used (no epinephrine) followed by resection using snare without using electrocautery in C-EMR group.After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps.
Bleeding will be assessed for 2 mins to decide upon requirement of immediate hemostatic methods in the form of clipping or electrocoagulation.
Hot snare endoscopic mucosal resection (H-EMR)
All procedures will be performed by experienced endoscopists (\>3 years of experience/\>1000 polypectomies) with the patient in the left lateral position under propofol sedation.Using ERBE electrosurgical unit - EndoCut Q mode (effect interval duration) and forced coagulation mode in H-EMR group.The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used.After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps.
Hot snare endoscopic mucosal resection (H-EMR)
All procedures will be performed by experienced endoscopists (\>3 years of experience/\>1000 polypectomies) with the patient in the left lateral position under propofol sedation.
The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used.submucosal injection of saline mixed with methylene blue will be used.Using ERBE electrosurgical unit - EndoCut Q mode (effect interval duration) and forced coagulation mode in H-EMR group.
After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps.
Interventions
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cold snare endoscopic mucosal resection (C-EMR)
All procedures will be performed by experienced endoscopists (\>3 years of experience/\>1000 polypectomies) with the patient in the left lateral position under propofol sedation.
The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used .
submucosal injection of saline mixed with methylene blue will be used (no epinephrine) followed by resection using snare without using electrocautery in C-EMR group.After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps.
Bleeding will be assessed for 2 mins to decide upon requirement of immediate hemostatic methods in the form of clipping or electrocoagulation.
Hot snare endoscopic mucosal resection (H-EMR)
All procedures will be performed by experienced endoscopists (\>3 years of experience/\>1000 polypectomies) with the patient in the left lateral position under propofol sedation.
The polyp size will be assessed by boston biopsy forceps (open jaws -7mm) or boston jumbo biopsy forceps (open jaws 10mm) or submucosal injection needle (Olympus (4mm)). A standard snare will be used.submucosal injection of saline mixed with methylene blue will be used.Using ERBE electrosurgical unit - EndoCut Q mode (effect interval duration) and forced coagulation mode in H-EMR group.
After polypectomy, the area is inspected for residual polyp using NBI and if present, will be resected using biopsy forceps.
Eligibility Criteria
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Inclusion Criteria
* polyp size greater than 5-10mm.
Exclusion Criteria
* Familial Polyposis Syndromes
* Patient who is unable to understand study protocol or not consenting
* Severe coagulopathy (INR Greater than 1.5 platelets)
* Receiving antiplatelets withing 5 days of procedure
* If antiplatelets stopped for 5 days-they were restarted on next day after procedure.
18 Years
75 Years
ALL
No
Sponsors
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Asian Institute of Gastroenterology, India
OTHER
Responsible Party
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Principal Investigators
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Krithi Krishna Koduri, MD
Role: PRINCIPAL_INVESTIGATOR
Asian Institute of Gastroenterology
Locations
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Krithi Krishna Koduri
Hyderabad, Telanagana, India
Countries
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Central Contacts
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Facility Contacts
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Nitin Jagtap, MD
Role: primary
Other Identifiers
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C-EMR VS H-EMR
Identifier Type: -
Identifier Source: org_study_id
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