Hybrid-APC Margin Ablation to Prevent Post EMR Adenoma Recurrence (h-APC EMR)
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|ClinicalTrials.gov Identifier: NCT04015765|
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Polyp of Colon||Procedure: Hybrid Argon Plasma Coagulation and EMR procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hybrid-APC Margin Ablation to Prevent Post EMR Adenoma Recurrence|
|Estimated Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||July 1, 2022|
Experimental: Group treatment h-APC and EMR
Standard endoscopic mucosal resection (EMR) technique will be used for 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 (e.g. NaCl 0.9% 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 (e.g. ERBE VIO Endocut 3-1-6). Ablation of the margin after visibly complete removal of the polyp is routinely applied. For thermal ablation hybrid APC (Erbe Hybrid APC) will be applied using standard settings on the margin and resection base. Once resection and thermal ablation is considered complete the mucosal defect can be closed with clips or another preventative measure applied to reduce the risk for post-polypectomy bleeding.
Procedure: Hybrid Argon Plasma Coagulation and EMR procedure
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 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
- Evaluate adenoma recurrence rate [ Time Frame: 3-6 months after the index h-APC and EMR procedure ]The primary aim of the study is to evaluate adenoma recurrence rate after EMR and h-APC margin ablation at the first follow-up colonoscopy.
- Evaluate complete adenoma eradication rates [ Time Frame: Within 1 year after the inder EMR ]The secondary aims of the study are to evaluate complete adenoma eradication rates within 1 year after the index EMR when using EMR with margin ablation and ablating all recurrence found at the first follow up colonoscopy with h-APC.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04015765
|Contact: Daniel von Renteln, MD||5148908000 ext email@example.com|
|Contact: Leslie Motchum||5148908000 ext firstname.lastname@example.org|