Recruiting nowNot phasedRandomised
| Registry number | NCT06815406 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | randomised, open label |
| Taking part | 282 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Azienda USL Reggio Emilia – IRCCS |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Procedure Endoscopic Mucosal Resection (EMR)
- Procedure Endoscopic Submucosal Dissection (ESD)
What it is measuring
Recurrence/Adenomatous Residual Rate
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
What this trial is trying to do
The researchers are testing whether endoscopic submucosal dissection (ESD), which removes a lesion in one piece, leaves less residual or recurrent adenomatous tissue than endoscopic mucosal resection (EMR), which often removes larger lesions in several pieces. The comparison is in people with laterally spreading granular tumours (LST-G) larger than 20 mm in the colon or rectum.
The idea is that removing the lesion in one piece may reduce local recurrence and allow more complete examination of its edges, compared with standard EMR. The trial will measure recurrence or residual adenomatous tissue at 6 and 12 months, while also recognising that ESD takes longer and may cause more complications.
Worth knowing: This is a procedure comparison with no drug treatment, and the main outcome is local recurrence or residual tissue rather than survival; ESD also requires greater technical expertise and may carry more complications.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
Colorectal cancer is one of the leading causes of cancer-related mortality worldwide. Early-stage non-polypoid neoplastic lesions, particularly Laterally Spreading Tumors – Granular Type (LST-G) larger than 20mm, require effective endoscopic removal to prevent malignant progression. The two primary techniques for resecting these lesions are Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD).
EMR is a widely used, minimally invasive technique that involves resecting the lesion with a diathermic snare after submucosal injection. While effective and safe, EMR often necessitates piecemeal resection, increasing the risk of local recurrence. In contrast, ESD, developed in Asia, allows for en bloc resection regardless of lesion size, ensuring more accurate histopathological assessment and lower recurrence rates. However, ESD requires greater technical expertise, has longer procedural times, and carries a higher risk of complications.
In Western clinical practice, EMR remains the standard treatment, whereas ESD is selectively performed in high-expertise centers.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Rectal
- Colon
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- Age ≥ 18 years.
- Diagnosis of Laterally Spreading Tumor – Granular Type (LST-G) ≥ 20 mm in the colon or rectum with an indication for endoscopic resection.
- Life expectancy > 10 years.
- Ability to understand and sign the informed consent form, demonstrating comprehension of the study and willingness to participate.
Exclusion Criteria
- Diagnosis of Laterally Spreading Tumor – Non-Granular Type (LST-NG).
- Presence of depressed areas within the lesion.
- Lesions located on a scar or anastomosis site.
- Lesions classified as Kudo Vi or Vn pattern.
- History of chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease).
- Diagnosis of hereditary polyposis syndromes (e.g., familial adenomatous polyposis, Lynch syndrome).
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 5 sites. Listed in: Italy.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT06815406, registered by Azienda USL Reggio Emilia – IRCCS on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.