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Glowing dye during surgery may cut dangerous bowel leaks

NCT ID NCT06793280

Disease control Sponsor: University of Roma La Sapienza 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether injecting a special dye (ICG) during laparoscopic colorectal cancer surgery helps surgeons see blood flow and choose a safer spot to cut. Over 560 adults took part, with half getting the dye and half relying on the surgeon's usual judgment. The main goal was to see if the dye reduces the rate of anastomotic leaks, a serious complication that can cause severe illness or death.

What this could mean

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

Active substance
indocyanine green (ICG) dye injection
What this could lead to
If this method works, it could help surgeons decide where to cut during colorectal surgery, potentially lowering the risk of dangerous post-surgery leaks.
What could go wrong
An earlier small trial found no clear benefit, so this larger study may also show no significant reduction in leaks. The dye itself can cause rare allergic reactions.

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

562 people

The number who actually took part.

Started

Feb 2022

Finished

Mar 2026

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: * Age: 18-85 years * Malignant colorectal tumors * Elective surgery Exclusion Criteria: * Abdomino-perineal resection * Emergency procedures * Conversion to open surgery * No anastomosis * Multifocal tumors * Locally advanced cancer (T4) * Distant metastases (M+) * Major vasculopathies (previous PE, DVT, abdominal aorta surgery) * ICG allergy

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak colorectal cancer colorectal neoplasm

As listed by the trial registrant

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

Anastomotic leak

Contacts and locations

Locations

  • Lidia Castagneto Gissey

    Roma, Italy, 00161, Italy

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