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Compares treatment options for Neoplasms, Colorectal
Official title Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Colorectal Laterally Spreading Lesions.
ClinicalTrials.gov ID: NCT04593407
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- 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...
- Patients able to fill in questionnaires written in Spanish or English.
You likely can't join if
- 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.
- LSL-NG FE type ≥ 20mm or LST-G ≥30mm mixed type that have been previously treated (Recurrence or residual lesion after previous endoscopic or...
- 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...
See the full eligibility criteria
- 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...
- Patients able to fill in questionnaires written in Spanish or English.
- 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.
- 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.
- 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.
- 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-G with a Buddha like deformation (Polyp on polyp)
- LSL involving a surgical anastomosis.
- LSL involving the appendicular orifice.
- LSL involving the terminal ileum.
- Patient's refusal to participate in the study
- Presence of inflammatory bowel disease
- Pregnant or lactating women.
- Hereditary colorectal cancer syndrome or hereditary polyposis.
- Patient under legal protection and or deprived of liberty by judicial or administrative decision.
- Patient already participating in an treatment clinical research protocol
- Patient who cannot be followed for the duration of the study.
- Inability to sign the informed consent of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.