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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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 criteria

Qualifiers

Adult patients

Undergoing EMR for large (≥20 mm) colorectal LSL

Providing written and informed consent for study participation

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Adjuvant thermal ablation
  • No adjuvant thermal ablation

Treatment groups

752 Participants
are divided into 2 treatment groups