The goal of this clinical trial is to clarify the role of adjuvant thermal ablation for non-thermal endoscopic mucosal resection (EMR) of large (≥20mm) flat colorectal polyps (so-called laterally spreading lesions \[LSLs\]).
The hypothesis is that adding adjuvant thermal ablation to non-thermal EMR (vs no ablation) will result in lower lesion recurrence rates at 6-month follow-up, and non-inferior adverse events (AE) rates 14 days post EMR.
For participants with planned EMR, endoscopists will perform non-thermal EMRs as per standard of care and:
* adjuvant thermal ablation will either not be performed (control group), or will be applied to the base and outside margins of the resection site (experimental group); * then, all patients will be contacted 14-44 days after EMR, to verbally ascertain the occurrence of AEs; * then, all patients will undergo a first follow-up colonoscopy at 6 months after initial conoloscopy to assess lesion recurrence; * finally, all patients will undergo a second and final colonoscopy 18 months after EMR.
Adult patients
Undergoing EMR for large (≥20 mm) colorectal LSL
Providing written and informed consent for study participation
Inflammatory bowel disease
Non-elective colonoscopy
Poor general health (American Society of Anesthesiologists classification >III)
Coagulopathy or thrombocytopenia (international normalized ration ≥1.5 or platelets <50*10^9/L)
Parallel
Adjuvant thermal ablation
Procedure/SurgeryWhen the endoscopist determines that the resection is complete, submucosal injection (0.9% NaCl with methylene blue solution) using the h-APC probe (ERBEJET 2 attached to Vio3 electrosurgical unit, pressure: 40 bar) will be performed to further expose the resection margin. Adjuvant thermal ablation will be applied to the outside margins of the resection site using the h-APC probe. Adjuvant thermal ablation will then also be applied to the base of the resection site using the h-APC probe. The precise electrocautery mode (PRECISE-APC setting 9) will be used to apply thermal ablation, as previously described for h-APC.
No adjuvant thermal ablation
Procedure/SurgeryAfter performing non-thermal EMR with thermal ablation, adjuvant thermal ablation will not be performed.
Lesion recurrence rate
Defined as the number of cases with pathology-confirmed hyperplastic, serrated, or adenomatous histology at the tattooed resection site compatible with the study polyp histology divided by the total number of cases.
Clinically significant adverse event (AE) rate
Defined as the number of cases with delayed bleeding (blood per rectum resulting in emergency room visit, unplanned hospitalization, endoscopic, radiologic, or surgical intervention) and/or delayed perforation (endoscopic or radiologic evidence of significant air or any luminal contents outside the gastrointestinal tract) divided by the total number of cases.
Any delayed bleeding rate
Defined as the number of cases with blood per rectum, regardless of clinical significance, divided by the total number of cases.
Lesion recurrence rate at 18-month follow-up
Defined as the number of cases with pathology-confirmed hyperplastic, serrated, or adenomatous histology at the tattooed resection site compatible with the study polyp histology divided by the total number of cases.
High-grade dysplasia rate at the 18-month follow-up
Defined as the number of cases with high-grade dysplasia on resection scars divided by the total number of cases.
Rate of CRC during the 18-month follow-up period
Defined as the number of cases with pathology-confirmed carcinomas divided by the total number of cases.
Colonoscopies to lesion clearance
Defined as the total number of colonoscopies required to achieve lesion clearance, which means no histologic recurrence at the resection scar on follow-up.
EMR procedure time
Defined as the length of time required for the initial EMR.
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