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Dye-Free laser imaging could replace standard dye in colorectal surgery

NCT ID NCT07720505

Diagnosis Sponsor: Leiden University Medical Center Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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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 Results may not be published yet.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
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)
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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This status has not been confirmed recently, so it may be out of date.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 Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This study compares two imaging methods for checking blood flow to the bowel during colorectal surgery: the standard technique using a dye called indocyanine green (ICG) and a newer dye-free method called Laser Speckle Contrast Imaging (LSCI). About 30 adults having elective colon or rectal surgery with a bowel connection will have both imaging methods used during their operation. Surgeons will make decisions based only on the standard ICG images, while the LSCI images are collected for comparison. The goal is to see if LSCI can provide objective, dye-free perfusion assessment that matches or improves upon current practice.

What this could mean

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

Active substance
Laser Speckle Contrast Imaging (LSCI) compared with indocyanine green (ICG) fluorescence imaging
What this could lead to
If LSCI proves as reliable as ICG, it could offer a safer, dye-free way to assess bowel perfusion during surgery, potentially reducing allergic reactions and simplifying the procedure.
What could go wrong
This is a small, early-stage observational study in 30 patients, so results may not generalize. LSCI might not match ICG's accuracy, and technical limitations could hinder its use in real-world surgery.

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.

Participants

About 30 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Sep 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.

Who is studied

The population for this study consists of adult patients undergoing elective colon or rectal resection with the creation of a primary anastomosis

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: * Adults ≥18 years. * Undergoing elective colon resection with primary anastomosis. * Able to provide consent for postoperative analysis of intraoperative imaging Exclusion Criteria: * Palliative surgery. * Factors that severely limit intraoperative visualization (per investigator judgement). Conditions interfering with perfusion assessment (e.g., severe peripheral vascular compromise).

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Conditions

The condition(s) this trial relates to.

Anastomotic Leak benign colon neoplasm colon carcinoma colonic neoplasm colorectal cancer rectal cancer rectal disorder rectal neoplasm

As listed by the trial registrant

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

Colon anastomosis Colon and rectal cancer Colon and rectal diseases Colon benign tumor Colon cancer Indocyanine green (ICG) Laser speckle contrast imaging Leakage, anastomotic Near-infrared spectroscopy

How to take part

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  1. The official record

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  2. A doctor treating you

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