RecruitingNot ApplicableNCT04593407

Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Colorectal Laterally Spreading Lesions.

Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Laterally Spreading Lesions Non Granular-Flat Elevated Type (LSL-NG-FE) ≥ 20 mm and LSLs-Granular Mixed Type ≥ 30 mm. A Randomized, Non-inferiority Trial.


Sponsor

José Carlos Marín Gabriel

Enrollment

376 participants

Start Date

Nov 3, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

EMR and ESD are both effective and safe and are associated with a very low risk of procedure related mortality when performed for colorectal laterally spreading lesions (LSL). Some kind of LSLs have a low risk of submucosal invasive carcinoma (SMIC) or these foci are found in well demarcated areas of the tumor. This is the case of the non-granular flat elevated (LSN-NG-FE) and the LSLs-G mixed subtypes. The investigators aim to assess if piecemeal EMR (the older technique) for LSLs-G mixed type \> 30 mm and LSLs-NG FE type \> 20 mm is not inferior to ESD (the new treatment) for the need of additional surgery in the mid-term.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study compares two methods of removing large polyps or precancerous lesions from the colon using a colonoscope: EMR (endoscopic mucosal resection), which uses a snare to remove tissue, versus ESD (endoscopic submucosal dissection), which cuts out tissue in a single piece. The goal is to find out which approach is safer and more effective for specific types of lesions. **You may be eligible if...** - You are 18 or older - You have a specific type of large colon lesion (at least 20–30 mm depending on the type) that has not been previously treated - You have had or will have a full colonoscopy to check the rest of the colon - You are able to complete questionnaires in Spanish or English **You may NOT be eligible if...** - You have a health condition that prevents you from having a colonoscopy or anesthesia - You cannot safely stop blood thinners before the procedure - Your lesion has already been treated or injected previously - Your lesion shows signs of deep invasion (suggesting cancer) - You have more than one qualifying lesion Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREEndoscopic mucosal resection (EMR)

Endoscopic mucosal resection (EMR) is an endoscopic resection technique that allows the removal of large colorectal lesions using a conventional "lift-and-cut" procedure or an underwater technique

PROCEDUREEndoscopic submucosal dissection (ESD)

Endoscopic submucosal dissection (ESD) is an endoscopic procedure that allows dissection of larger colorectal lesions in one piece using endoknives. The procedure is technically more difficult, much more time-consuming than EMR, mandates multiday hospital admission and has an increased risk of perforation.


Locations(1)

Hospital Universitario "12 de Octubre"

Madrid, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04593407


Related Trials