Ignite Creation Date:
2024-05-06 @ 1:23 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04015765
Status:
RECRUITING
Last Update Posted:
2023-12-20
First Post:
2019-07-04
Brief Title:
Hybrid-APC Margin Ablation to Prevent Post EMR Adenoma Recurrence
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
Hybrid-APC Margin Ablation to Prevent Post EMR Adenoma Recurrence
Status:
RECRUITING
Status Verified Date:
2023-12
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:
h-APC_EMR
Brief Summary:
Endoscopic Mucosal Resection EMR is the current standard for effective endoscopic resection of such colon adenomas If resection is possible in one piece so-called en bloc resection then recurrence rates are low However most non-pedunculated polyps 2 cm are removed in pieces piece-meal resection which leads to disease recurrence rates between 12-30 In the March 2019 issue of Gastroenterology Bourke et al presented that post-EMR ablation of the resection margins using soft coagulation with the tip of a resection snare reduces adenoma recurrence to 5 compared to 21 recurrence found in the control group Hybrid Argon Plasma Coagulation h-APC combines an ablation technique APC with the option for submucosal saline injection using a high-pressure water jet The technique allows to lift of dysplastic epithelium thus creating a safety cushion under the mucosa is lifted with a saline injection and then to ablate larger areas more thoroughly and with a higher energy setting with a low risk for side effects or complications
Detailed Description:
Our study hypothesis is that routine use of hybrid Argon Plasma Coagulation h-APC for ablation of the post-EMR resection margins and resection surface area will reduce post-EMR adenoma recurrence to 5 or lower
This is a prospective multi-center study enrolling patients with non-pedunculated colorectal polyps 20mm for endoscopic mucosal resection EMR All primary EMR procedures will combine EMR with h-APC ablation of the base and margins after complete EMR resection to prevent adenoma recurrence
Schedule of activities
1 Enrollment visit before the endoscopy ALL PATIENTS in the outpatient clinic or before the EMR
Eligible patients who have consented to participate in the study will be asked to take a standard colonoscopy preparation before their scheduled procedure
2 EMR intervention ALL PATIENTS meeting eligibility criteria Only if a polyp meets inclusion criteria the study subject will be enrolled The standard endoscopic mucosal resection EMR technique will be used for the primary removal of all polyps Submucosal injection will be used to lift the polyp from the muscularis propria Injection is used as per the current standard of care using a contrast agent and a lifting agent eg NaCl 09 or Voluven Snare electrocautery resection will be facilitated until complete visible removal of the complete polyp Electrocautery snare technique is facilitated using standard microprocessor-controlled electrocautery If residual polyp tissue cannot remove by a snare other means such as cold snare ie for small residual polyp tissue that cannot be engaged into standard snares hot avulsion technique or Argon plasma coagulation or soft coagulation by the tip of snare can be used
The polyp site will be marked with submucosal injection of approximately 1-2cc of India ink standard of care to mark lesions in the colon safely to allow recognition at follow-up endoscopy Polyps are sent to the pathology lab and evaluated according to standard practice by institutional pathologists19 To determine the homogeneity and depth of h-APC margin ablation in the pathology lab some ablated margins might be resected using the standard cold snare technique
Telephone calls or visits 14-30 days following the EMR will be conducted to assess possible adverse events
3 Follow-up 1 FU1 ALL PATIENTS colonoscopy 4 months 2 months after the EMR intervention with the assessment of the primary outcome biopsypathology-confirmed recurrence at post-EMR site Patients with visible recurrence at the EMR site will undergo additional h-APC treatment for complete eradication at the first follow-up
4 Follow-up 2 ONLY FOR PATIENTS with visible recurrence and biopsy confirmed recurrence at FU1 will undergo FU2 scheduled 4 months 2 months after FU1 within 1 year after EMR procedure with the assessment of recurrencecomplete eradication rates biopsypathology confirmed complete eradication post-EMR and h-APC at FU1
5 Patients with not visible but pathology-confirmed recurrence will be rescheduled for another colonoscopy with h-APC treatment of the post-EMR site and another follow-up colonoscopy for biopsies and confirmation of completeincomplete eradication within 1 year after the initial EMR
This is a prospective multi-center study enrolling patients with non-pedunculated colorectal polyps 20mm for endoscopic mucosal resection EMR All primary EMR procedures will combine EMR with h-APC ablation of the base and margins after complete EMR resection to prevent adenoma recurrence
Schedule of activities
1 Enrollment visit before the endoscopy ALL PATIENTS in the outpatient clinic or before the EMR
Eligible patients who have consented to participate in the study will be asked to take a standard colonoscopy preparation before their scheduled procedure
2 EMR intervention ALL PATIENTS meeting eligibility criteria Only if a polyp meets inclusion criteria the study subject will be enrolled The standard endoscopic mucosal resection EMR technique will be used for the primary removal of all polyps Submucosal injection will be used to lift the polyp from the muscularis propria Injection is used as per the current standard of care using a contrast agent and a lifting agent eg NaCl 09 or Voluven Snare electrocautery resection will be facilitated until complete visible removal of the complete polyp Electrocautery snare technique is facilitated using standard microprocessor-controlled electrocautery If residual polyp tissue cannot remove by a snare other means such as cold snare ie for small residual polyp tissue that cannot be engaged into standard snares hot avulsion technique or Argon plasma coagulation or soft coagulation by the tip of snare can be used
The polyp site will be marked with submucosal injection of approximately 1-2cc of India ink standard of care to mark lesions in the colon safely to allow recognition at follow-up endoscopy Polyps are sent to the pathology lab and evaluated according to standard practice by institutional pathologists19 To determine the homogeneity and depth of h-APC margin ablation in the pathology lab some ablated margins might be resected using the standard cold snare technique
Telephone calls or visits 14-30 days following the EMR will be conducted to assess possible adverse events
3 Follow-up 1 FU1 ALL PATIENTS colonoscopy 4 months 2 months after the EMR intervention with the assessment of the primary outcome biopsypathology-confirmed recurrence at post-EMR site Patients with visible recurrence at the EMR site will undergo additional h-APC treatment for complete eradication at the first follow-up
4 Follow-up 2 ONLY FOR PATIENTS with visible recurrence and biopsy confirmed recurrence at FU1 will undergo FU2 scheduled 4 months 2 months after FU1 within 1 year after EMR procedure with the assessment of recurrencecomplete eradication rates biopsypathology confirmed complete eradication post-EMR and h-APC at FU1
5 Patients with not visible but pathology-confirmed recurrence will be rescheduled for another colonoscopy with h-APC treatment of the post-EMR site and another follow-up colonoscopy for biopsies and confirmation of completeincomplete eradication within 1 year after the initial EMR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None