NCT04593407Active, not recruiting
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.
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 236 (estimated)
- First submitted
- 13 Oct 2020
- Start date
- 1 Dec 2020
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- José Carlos Marín Gabriel
- Diseases
- Colorectal cancer
- NCT number
- NCT04593407
What you commit to
- Study type: Interventional
- Planned participants: 236
- From 1 Dec 2020 to the primary completion date, 31 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- LSL-NG FE type ≥ 20mm or LST-G ≥30mm mixed type that have been previously treated (Recurrence or residual lesion after previous endoscopic or surgical treatment).
- LSL-NG FE type ≥ 20mm or LST-G ≥30mm mixed type with previous submucosal injection, even if a resection attempt with a snare was not finally performed.
- LSLs having a previous biopsy or tattooing. Previous biopsies of the lesion should only be allowed if LSL-G mixed type \> 30 mm and samples were taken out of the flat area.
- LSL involving a surgical anastomosis.
Other illness
- Presence of inflammatory bowel disease
- Hereditary colorectal cancer syndrome or hereditary polyposis.
Other
- Contra-indication to colonoscopy.
- Contra-indication to general anesthesia.
- Inability to stop antiplatelet agents and anti-coagulant according to the European Society of Gastro-Intestinal Endoscopy guidelines.
- Patients with \> 1 lesion meeting the inclusion criteria.
- Lesions with suspicion of deep submucosal invasive carcinoma: depression or invasive pit-pattern (Vi within a demarcated area or Vn).
- Submucosal mass like elevation within a LSL-NG FE type.
- LSL-G with a Buddha like deformation (Polyp on polyp)
- LSL involving the appendicular orifice.
- LSL involving the terminal ileum.
- Patient's refusal to participate in the study
- Pregnant or lactating women.
- Patient under legal protection and or deprived of liberty by judicial or administrative decision.
- Patient already participating in an interventional clinical research protocol
- Patient who cannot be followed for the duration of the study.
- Inability to sign the informed consent of the study.
Who the study is looking for
- Adults (at least 18 years old).
- LSL-NG FE type ≥ 20mm or LST-G mixed type ≥30mm who have not been previously treated or received submucosal injection, regardless of their location in the colon.
- LSL-NG FE type ≥ 20mm or LST-G mixed type ≥30mm WITHOUT a demarcated area
- The patient must have undergone a complete colonoscopy, reaching the cecum, to detect possible synchronous lesion. If this procedure has not been done previously, it will be performed prior to the inclusion of the patient in the study.
- Patients able to fill in questionnaires written in Spanish or English.
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.