Ignite Creation Date:
2024-05-06 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03390907
Status:
COMPLETED
Last Update Posted:
2021-11-08
First Post:
2017-12-29
Brief Title:
Hybrid APC Assisted EMR for Large Colon Polyps
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Hybrid APC Assisted EMR for Large Colon Polyps to Reduce Local Recurrence A Prospective Data Collection Study
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study to evaluate and examine whether use of Hybrid Argon Plasma Coagulation APC as an adjunct to endoscopic mucosal resection EMR will reduce the risk of residual or recurrent neoplasia at 6 months Hybrid APC is an existing FDA approved device used to assist with ablation of abnormal tissue anywhere in the GI tract
Detailed Description:
Colon Cancer is a major disease that effects more than 1 million people per year globally Adenomatous polyps have been identified as the main precursor leading to colorectal cancer Colon cancer screening is the best way to detect and remove large often asymptomatic polyps Early detection and resection of these colorectal polyps can prevent the development of colon cancer Endoscopic mucosal resection EMR is a technique used for resection of medium to large colon polyps In this technique fluid is injected into the submucosa creating a cushion between the mucosa and the muscularis propria An electrocautery snare is then deployed to resect the polyp in a single en-bloc or multiple piecemeal pieces Most polyps 2 cm are resected in piecemeal way Although EMR is now considered standard of care with a successful resection rate of 85 and low risk of complication 3-10 bleeding and 1 perforation this technique has inherent deficiencies especially piecemeal EMR Recurrence rates following piecemeal EMR can be as high as 20 Resection of scarred polyps using this technique is particularly challenging due to the non-lifting of the polyp Endoscopic submucosal dissection ESD is an alternative approach that aims to remove non- pedunculated precancerous or cancerous lesions over 20 mm in one piece en-bloc resection rate of 8995 and lesion recurrence rate of 07 However due to its technical complexity and high complication risk mainly bleeding and perforation with complication rates approximately 8 it is not the current standard of care and only performed by experts in the technique
Hybrid Argon plasma coagulation APC is a new technique in which the endoscopist reinjects the submucosa with fluid to create a cushion normal saline diluted adrenaline and or sodium hyaluronate solution to protect the muscle layer and then ablation is done using spray argon coagulation to treat any microscopic residual disease that is the seed for local recurrence Previous studies have shown that this technique is a safe and easily applicable technique to complete resection for recurrent polyps after first EMR
Investigators hypothesize that with Hybrid APC assisted EMR there will be a decrease in recurrence rate after 6 months and it will be more effective compared to the standard EMR procedure
This is a pilot study in which patients with non-pedunculated large polyps 20mm undergoing endoscopic mucosal resection EMR will be recruited Following standard EMR all patients will undergo adjuvant Hybrid Argon Plasma Coagulation APC of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease Resected polyps will be sent to the pathology laboratory where pathologist determine the final diagnosis of the polyps as per standard of care
Hybrid Argon plasma coagulation APC is a new technique in which the endoscopist reinjects the submucosa with fluid to create a cushion normal saline diluted adrenaline and or sodium hyaluronate solution to protect the muscle layer and then ablation is done using spray argon coagulation to treat any microscopic residual disease that is the seed for local recurrence Previous studies have shown that this technique is a safe and easily applicable technique to complete resection for recurrent polyps after first EMR
Investigators hypothesize that with Hybrid APC assisted EMR there will be a decrease in recurrence rate after 6 months and it will be more effective compared to the standard EMR procedure
This is a pilot study in which patients with non-pedunculated large polyps 20mm undergoing endoscopic mucosal resection EMR will be recruited Following standard EMR all patients will undergo adjuvant Hybrid Argon Plasma Coagulation APC of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease Resected polyps will be sent to the pathology laboratory where pathologist determine the final diagnosis of the polyps as per standard of care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None