Colorectal Cancer Clinical Trial
— ABLATIONOfficial title:
Prophylactic Double Thermal Ablation After Endoscopic Mucosal Resection of Large Non-Pedunculated Colorectal Polyps: A Randomized Controlled Trial - (ABLATION Trial)
Verified date | June 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. 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.
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 |
---|---|---|---|---|
Other | Clinically significant delayed bleeding after EMR with STSC or h-APC | Defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention. | 30 days | |
Other | Clinically significant delayed bleeding in the proximal colon after EMR with STSC or h-APC | Defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention. Proximal defined as proximal to the splenic flexure. | 30 days | |
Other | Delayed perforation after EMR with STSC or h-APC | Delayed perforation defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract | 30 days | |
Other | Factors associated with recurrence after colorectal EMR between the h-APC and STSC methods | Lesion recurrence at first follow-up after EMR of large (=20mm) colorectal LSLs when performing STSC margin ablation or h-APC margin and base ablation. Defined by pathology-confirmed hyperplastic, serrated or adenomatous histology of the same histology of the index lesion at the tattooed resection site on at least one of four random biopsies of resection scars. Factors such as age, sex, lesion size (20-29mm, =30mm; 20-39mm, =40mm), histology, location, difficulty (difficult defined as peri-appendiceal, on the ileocecal valve, resection previously attempted and failed by a referring endoscopist), use of epinephrine in submucosal injection, submucosal lifting solution, resection type (en bloc [i.e. in one piece] vs piecemeal), technical success, study site, endoscopist yearly EMR volume, presence of intraprocedural bleeding, utilization of adjunct resection methods, ileocecal or anus involvement, polyp histology/morphology will be evaluated. | 4 years | |
Other | Factors associated with adverse event rates after EMR with STSC or h-APC | Adverse event rates after EMR of large (=20mm) colorectal LSLs when performing EMR with STSC margin ablation or h-APC margin and base ablation. Defined as either a) delayed bleeding (defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention) or b) delayed perforation (defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract). Factors such as age, sex, lesion size, morphology, histology, location, complete/incomplete/no defect closure, prophylactic vessel ablation, base ablation, anticoagulant use will be evaluated | 30 days | |
Primary | Recurrence after colorectal EMR between the h-APC and STSC methods | Lesion recurrence at first follow-up after EMR of large (=20mm) colorectal LSLs when performing STSC margin ablation or h-APC margin and base ablation. Defined by visual recurrence or pathology-confirmed hyperplastic, serrated or adenomatous histology of the same histology of the index lesion at the tattooed resection site on at least one of four random biopsies of resection scars. These will be evaluated from an intention to treat and per protocol standpoint. | 4 years | |
Secondary | Adverse event rates after EMR with STSC or h-APC | Adverse event rates after EMR of large (=20mm) colorectal LSLs when performing EMR with STSC margin ablation or h-APC margin and base ablation. Defined as either a) delayed bleeding (defined as blood per rectum resulting in emergency room visit, unplanned hospitalization; endoscopic, radiologic, or surgical intervention) or b) delayed perforation (defined as endoscopic or radiologic evidence of air or luminal contents outside the gastrointestinal tract). These will be evaluated from an intention to treat and per protocol standpoint. | 4 years | |
Secondary | Technical success of STSC or h-APC | Technical success of STSC or h-APC defined as achieving a complete uninterrupted ring ofcircumferential margin ablation for STSC and h-APC, without crossover to complete the margin ablation, and achieving 100% surface ablation of the resection base for h-APC. | 4 years | |
Secondary | Lesion recurrence at the 18-month follow-up after EMR with STSC or h-APC | Lesion recurrence at the 18-month follow-up after EMR with STSC or h-APC | 4 years | |
Secondary | High-grade dysplasia or colorectal cancer occurence after EMR during the 18-month follow-up period. | High-grade dysplasia or colorectal cancer occurence after EMR during the 18-month follow-up period at the resection site. | 4 years |
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