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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.