Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions (NCT04418843) | Clinical Trial Compass
CompletedNot Applicable
Cold EMR Vs Standard EMR for the Treatment of Large Nonpedunculated Homogeneous Colorectal Lesions
Spain229 participantsStarted 2020-06-08
Plain-language summary
This study compares the effectiveness in complete resection (absence of recurrence at 6 months) the two different techniques for performing endoscopic mucosal resection (EMR) of nonpedunculated homogeneous colorectal lesions \>20mm
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients of age \> 18 years undergoing a colonoscopy for any reason of request and who do not meet exclusion criteria.
* Nonpedunculated homogeneous colorectal lesions type LST ( Paris 0-IIa morphology) and serrated lesions larger than 20 mm without endoscopic data of malignancy: NICE 1 pattern +/- NICE 2 component ( serrated lesions) or NICE2 pattern/JNET 2A (adenomas) and therefore subsidiaries of RME. Randomization will be performed per patient, not for colorectal lesions
* Signature of informed consent of endoscopic exploration
Exclusion Criteria:
* .No signature of informed consent prior to the study procedure.
* Absence of proper suspension of the anticoagulant/antiplatelet therapy prior to procedure according to usual pre-procedure recommendations (BSG and ESGE guidelines)
* Patients with severe thrombopenia/ coagulopathy (Platelets \< 50,000/INR \> 1.5) not corrected prior to procedure (plasma or platelet transfusion)
* Patients not candidates for endoscopic resection of colorectal lesions by comorbidities.
* Pregnant.
* Patients with inflammatory bowel disease (IBD)
* Urgent colonoscopy.
* Poor preparation (BBPS \<2 in the colon segment where the lesion is located)
* Laterally spreading tumors (LST) lesions with non-homogeneous morphology including: sessile polyps (0-Is), pedunculated (0-Ip) and LST lesions with depressed or excavated components (Paris 0-IIc or Paris 0-III), LST granular nodular mixed, LST-G with whole nodular type. In case o…