Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271941
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-02-15
Brief Title:
Prophylactic Double Thermal Ablation After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
Prophylactic Double Thermal Ablation After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps A Randomized Controlled Trial - ABLATION Trial
Status:
RECRUITING
Status Verified Date:
2024-07
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:
ABLATION
Brief Summary:
Large 20mm colorectal polyps often harbor areas of advanced neoplasia making them immediate colorectal cancer CRC precursors Such polyps have to be completely removed to prevent CRC and to avoid surgery andor adjuvant therapy The laterally spreading lesions LSLs are removed via endoscopic mucosal resection EMR However recurrence is common Recent studies have found that the use of hybrid argon plasma coagulation h-APC for the ablation of the margin and base of resection post-EMR could significantly reduce the recurrence rate and complete closure of the post-EMR defect can prevent other adverse pre- and post-procedure outcomes such as bleeding
It is hypothesized that hypothesize that performing hybrid argon plasma coagulation h-APC margin and base ablation post-EMR for large 20mm colorectal LSLs will demonstrate a lower recurrence rate compared to Snare Tip Soft Coagulation STSC margin ablation It is also hypothesized that performing complete closure of the EMR defect will result in lower rates of adverse events compared to cases where no defect closure is performed
It is hypothesized that hypothesize that performing hybrid argon plasma coagulation h-APC margin and base ablation post-EMR for large 20mm colorectal LSLs will demonstrate a lower recurrence rate compared to Snare Tip Soft Coagulation STSC margin ablation It is also hypothesized that performing complete closure of the EMR defect will result in lower rates of adverse events compared to cases where no defect closure is performed
Detailed Description:
This is a prospective randomized controlled trial enrolling patients with non-pedunculated colorectal polyps 20mm who are referred for endoscopic mucosal resection EMR All primary EMRs will be randomized to either EMR with hybrid argon plasma coagulation h-APC ablation of the base and margins or EMR with Snare Tip Soft Coagulation STSC margin ablation groups Additionally each group will be randomized to either complete defect closure or not
Patients will be enrolled in the study before the endoscopy procedure or in the outpatient clinic
Eligible patients who have consented to participate in the study will be asked to take a standard colonoscopy preparation regimen before their scheduled procedure
EMR intervention will be performed for all eligible patients with a large laterally spreading lesions LSLs by expert endoscopists Only if a polyp meets inclusion criteria the study subject will be enrolled and randomized into one of these four groups
Group 1 EMR h-APC margin and base thermal ablation
Group 2 EMR STSC of the margin
The standard 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 will be 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 will be facilitated using standard microprocessor-controlled electrocautery If residual polyp tissue cannot be removed by a snare other means such as cold snare ie for small residual polyp tissue that cannot be engaged into standard snares or avulsive methods will be used After the complete removal of the polyp depending on the randomization group h-APC or STSC techniques will be used for margin and base or only margin ablation of the post-EMR defect
The polypectomy site will be tattooed with submucosal injection of approximately 1-2cc of India ink standard of care to mark lesions to allow recognition of the polypectomy site during follow-up endoscopy Polyps will be sent to the pathology lab and evaluated according to standard practice by institutional pathologists 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 at 20-30 days following the EMR will be conducted to assess possible adverse events
Follow-up 1 Surveillance colonoscopy at 6 months 2 months after the EMR intervention for the assessment of recurrence biopsy from the post-EMR site to be confirmed by pathology following the intervention h-APC and the control STSC techniques
Follow-up 2 Surveillance colonoscopy at 18 months 2 months after the EMR intervention for the assessment of recurrence biopsy from the post-EMR site to be confirmed by pathology at FU1
Patients with visible recurrence at the EMR site will undergo additional resection for complete eradication of recurrence Patients with no visible but pathology-confirmed recurrence will be rescheduled for another colonoscopy with subsequent treatment of the post-EMR site and another follow-up colonoscopy for biopsies and confirmation of completeincomplete eradication within 18 months after the initial EMR
Patients will be enrolled in the study before the endoscopy procedure or in the outpatient clinic
Eligible patients who have consented to participate in the study will be asked to take a standard colonoscopy preparation regimen before their scheduled procedure
EMR intervention will be performed for all eligible patients with a large laterally spreading lesions LSLs by expert endoscopists Only if a polyp meets inclusion criteria the study subject will be enrolled and randomized into one of these four groups
Group 1 EMR h-APC margin and base thermal ablation
Group 2 EMR STSC of the margin
The standard 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 will be 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 will be facilitated using standard microprocessor-controlled electrocautery If residual polyp tissue cannot be removed by a snare other means such as cold snare ie for small residual polyp tissue that cannot be engaged into standard snares or avulsive methods will be used After the complete removal of the polyp depending on the randomization group h-APC or STSC techniques will be used for margin and base or only margin ablation of the post-EMR defect
The polypectomy site will be tattooed with submucosal injection of approximately 1-2cc of India ink standard of care to mark lesions to allow recognition of the polypectomy site during follow-up endoscopy Polyps will be sent to the pathology lab and evaluated according to standard practice by institutional pathologists 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 at 20-30 days following the EMR will be conducted to assess possible adverse events
Follow-up 1 Surveillance colonoscopy at 6 months 2 months after the EMR intervention for the assessment of recurrence biopsy from the post-EMR site to be confirmed by pathology following the intervention h-APC and the control STSC techniques
Follow-up 2 Surveillance colonoscopy at 18 months 2 months after the EMR intervention for the assessment of recurrence biopsy from the post-EMR site to be confirmed by pathology at FU1
Patients with visible recurrence at the EMR site will undergo additional resection for complete eradication of recurrence Patients with no visible but pathology-confirmed recurrence will be rescheduled for another colonoscopy with subsequent treatment of the post-EMR site and another follow-up colonoscopy for biopsies and confirmation of completeincomplete eradication within 18 months 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?:
None
Is an FDA AA801 Violation?:
None