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Can a simpler scope technique match the complex one for large colon growths?

NCT ID NCT04593407

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 18, 2026 · Last updated Sep 18, 2026

Summary

Researchers compare two ways to remove large, non-cancerous growths from the colon. One method, endoscopic mucosal resection, removes the growth in pieces. The other, endoscopic submucosal dissection, removes it in one piece but takes longer and carries more risk. The trial tests whether the simpler method is as good at preventing the need for later surgery in adults with certain flat or mixed growths.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Endoscopic removal of large colon growths using either mucosal resection or submucosal dissection
What this could lead to
If the simpler technique works as well, patients could avoid a longer, riskier procedure and multiday hospital stays. It may also make treatment available in more hospitals.
What could go wrong
The simpler technique removes growths in pieces, so doctors may not get clear margins and could miss hidden cancer. The trial may show it leads to more follow-up surgery than the newer method.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 236 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2020

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 patient in the study. * Patients able to fill in questionnaires written in Spanish or English. Exclusion Criteria: * 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 interventional clinical research protocol * Patient who cannot be followed for the duration of the study. * Inability to sign the informed consent of the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hospital Universitario "12 de Octubre"

    Madrid, 28041, Spain

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