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OBJECTIVES The aim of the study is to compare the efficacy of cold snare EMR versus hot snare EMR for non-pedunculated polyps 10-20mm in size with respect to complete resection rates and adverse events.
DESIGN : A Randomised interventional study. Sample size: 330
This procedure will be performed by Endoscopists having above 3 years of experience you will be in the left lateral position under propofol sedation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cold snare endoscopic mucosal resection (C-EMR) | Active Comparator | 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. |
|
| Hot snare endoscopic mucosal resection (H-EMR) | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cold snare endoscopic mucosal resection (C-EMR) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the complete resection rate | Primary outcome will be tested with chi-square test or Fisher's exact test. The level of significance has been set at 5%. To quantify the magnitude of the difference the relative risk and odds ratio will be calculated with 95% confidence interval. | 1 YEAR |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary outcomes include procedure time, cost and adverse events. | Univariate and multivariate analysis will be done to determine which are the factors associated with clinical success and clinical recurrence. Kaplan-Meier survival analysis will be done for appearance clinical recurrence. | 1 YEAR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Krithi Krishna Koduri, MD | Contact | 9870083545 | 91 | drkrithivk@gmail.com |
| Nitin Jagtap, MD | Contact | 9182859523 | 91 | Docnits13@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Krithi Krishna Koduri, MD | Asian Institute of Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krithi Krishna Koduri | Recruiting | Hyderabad | Telanagana | 500082 | India |
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This is a single center randomized controlled study with two parallel groups with a 1:1 allocation ratio.
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The patients will be randomised to C-EMR and H-EMR by a computer generated sequence provided in turn by the research assistant. The patient, pathologist and statistician will be blinded.
|
| Hot snare endoscopic mucosal resection (H-EMR) | Procedure | 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. |
|
| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D011127 | Polyps |
| D007417 | Intestinal Polyps |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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