Ex Vivo Intraarterial Methylene Blue Injection Improve Nodal Staging Accuracy in Colorectal Cancer

What Was Tested

The trial (not phased) is built around Methylene blue (non-peptide stack partner).

Nodal staging holds both important prognostic and predictive value at colorectal cancer.

Regional lymph nodes are located close to the primary tumor in the mesocolon / mesorectum.

Current pathology and oncology standards require a separate examination of at least 12 lymph nodes each case to fulfill staging "accuracy" criteria.

It had two arms (groups): Methylene blue (experimental) and Control (no intervention).

Colorectal specimens were processed in the routine pathological work-up way.

The registry classes the interventions as other.

More on the Plan

The most important prognostic and predictive factor of colorectal cancer is the stage of disease at the time of diagnosis.

Precise staging, especially nodal staging is highly important for correct planning of oncotherapy, i.e. adjuvant chemotherapy.

Nodal staging relies on the proper surgical removal of mesocolon/mesorectum belonging to the the affected colorectal segment, as well as on the thorough pathology work-up of the specimen.

Current quality standards require examination of a minimum of 12 lymph nodes in order to reliably report N0 stage.

Who Took Part

Enrollment: 200 actual participants took part.

It was open to people of any sex aged from 18 years up to 100 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Colon or rectum resection performed. Malignant colorectal condition.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: acute surgery performed; final histology: benign.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Methylene blue (non-peptide stack partner), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2021-04-15 with completion listed for 2021-07-15.

It ran at 1 site in Hungary.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Total number of lymph nodes (time frame: Within 4 weeks after operation (at pathology work-up)). Positive lymph nodes (time frame: Within 4 weeks after operation (at pathology work-up)). Nodal staging accuracy (time frame: Within 4 weeks after operation (at pathology work-up)).

It also tracked 1 secondary outcome, for example Overall survival.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 200 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.