Colorectal Cancer Clinical Trial
Official title:
Prophylactic Double Thermal Ablation and Complete Closure After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps: A Randomized Controlled Trial - (HAPC-RCT)
Verified date | February 2024 |
Source | Centre hospitalier de l'Université de Montréal (CHUM) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 and/or 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. We 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. We also hypothesize 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.
Status | Not yet recruiting |
Enrollment | 892 |
Est. completion date | April 1, 2028 |
Est. primary completion date | October 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - adult =18 years old - patients undergoing EMR for a large (=20mm) colorectal LSL - patients providing written and informed consent for study participation. Exclusion Criteria: - inflammatory bowel disease; - non-elective colonoscopy; - poor general health (American Society of Anesthesiologists classification >III); - coagulopathy or thrombocytopenia (international normalized ratio =1.5 or platelets <50 x 109/L); - pedunculated polyps (Paris class Ip, Isp); - overt signs of deep submucosal invasive cancer (JNET 3); - biopsy proven invasive carcinoma in a potential study polyp. |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier de l'Université de Montréal | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To compare the recurrence rates after EMR colorectal between the h-APC and SSTC methods | To compare lesion recurrence after EMR of large (=20mm) colorectal LSLs when performing STSC margin ablation or h-APC margin and base ablation. | 4 years | |
Secondary | To assess the potential advantages associated with a complete defect closure | To compare adverse event rates after EMR of large (=20mm) colorectal LSLs when performing complete or no defect closure. | 4 years |
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