Actively Recruiting
Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Colorectal Laterally Spreading Lesions.
Led by José Carlos Marín Gabriel · Updated on 2025-03-13
376
Participants Needed
1
Research Sites
321 weeks
Total Duration
On this page
Sponsors
J
José Carlos Marín Gabriel
Lead Sponsor
S
Spanish Society of Digestive Endoscopy
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Colorectal Laterally Spreading Lesions.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults at least 18 years old
- Have a laterally spreading lesion non-granular flat elevated type 20 mm or larger, or granular mixed type 30 mm or larger
- Lesions have not been previously treated or received submucosal injection
- Lesions do not have a demarcated invasive area
- Have undergone complete colonoscopy reaching the cecum to detect other lesions
- Able to complete questionnaires in Spanish or English
You will not qualify if you...
- Contraindication to colonoscopy
- Contraindication to general anesthesia
- Unable to stop antiplatelet or anticoagulant medications as recommended
- Have more than one lesion meeting inclusion criteria
- Previously treated lesions or those with prior submucosal injection
- Lesions suspected to have deep invasive carcinoma
- Lesions with submucosal mass-like elevation
- Lesions with previous biopsy or tattooing outside allowed conditions
- Lesions with polyp-on-polyp deformation
- Lesions involving surgical anastomosis, appendicular orifice, or terminal ileum
- Refusal to participate in the study
- Presence of inflammatory bowel disease
- Pregnant or lactating women
- Hereditary colorectal cancer syndrome or hereditary polyposis
- Under legal protection or deprived of liberty
- Currently participating in another interventional clinical trial
- Unable to complete study follow-up
- Inability to sign informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Universitario "12 de Octubre"
Madrid, Spain, 28041
Actively Recruiting
Research Team
J
José C. Marín-Gabriel, Assoc. Prof.
CONTACT
E
Esperanza Ulloa-Márquez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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