Reducing Neoplasia Recurrence After Non-thermal Endoscopic Resection of Large Colorectal Polyps

Condition(s) studied

Investigational drug(s) / intervention(s)

Adjuvant thermal ablation: When 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: After performing non-thermal EMR with thermal ablation, adjuvant thermal ablation will not be performed.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Lesion recurrence rate — 6 months
  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 — 14 days
  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.

Trial sites (1)

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