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Battle of the scalpels: which surgery is best for early rectal cancer?

NCT ID NCT02885142

Disease control Sponsor: Assistance Publique Hopitaux De Marseille Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared two procedures for removing early-stage rectal cancer or precancerous growths: endoscopic submucosal dissection (ESD) and transanal endoscopic microsurgery (TEM). Both are less invasive than traditional surgery. The goal was to see which one removes the tumor more completely and safely. The trial was terminated early, so the results are limited.

What this could mean

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

Active substance
procedure
What this could lead to
If this trial succeeds, it could show which procedure is better for removing early rectal cancer with fewer complications.
What could go wrong
The trial was terminated early, so results may be incomplete. Both procedures are already used, so the benefit may be small.

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

368 people

The number who actually took part.

Start date

Nov 2016

Finished

Aug 2022

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 years and older

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: * Presenting with an ERT (i.e. rectal adenoma or rectal carcinoma Tis or staged usT1N0 on endorectal ultrasound) that can be alternately resectable by TEM or ESD * Histology proved by a preoperative biopsy Exclusion Criteria: * " Palliative " excision T2/3/4 or N+ * Preoperative radiochemotherapy (down-staging) * Metastatic cancer * Pregnant or breast-feeding women

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Conditions

The condition(s) this trial relates to.

anal carcinoma anus neoplasm rectal cancer rectal carcinoma rectum adenoma rectum carcinoma in situ

As listed by the trial registrant

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

Anal cancer

Contacts and locations

Locations

  • Assistance Publique Hôpitaux de Marseille

    Marseille, 13354, France

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