Endoscopic Vital Nerve Staining in Gastrointestinal Diseases

What Was Tested

The trial (early phase 1) is built around Methylene blue (non-peptide stack partner).

In this study, methylene blue (MB) was used as vital nerve staining agent.

During gastroenteroscopy, mucosal nerve staining was achieved by endoscopic submucosal injection of MB solution.

To observe the staining of nerve fibers, neurons and glial cells in mucosa and submucosa, as well as the morphological changes, density differences and function of mucosal nerve tissues in different gastrointestinal lesions, in order to explore the role of endoscopic vital nerve staining in the diagnosis of gastrointestinal lesions.

It had 1 arm (groups): Endoscopic nerve staining (experimental).

Methylene blue (MB) solution was used as nerve staining agent. Routine endoscopic submucosal injection of MB solution for mucosal nerve staining was used to identify and evaluate the neural architecture and special morphology of normal gastrointestinal mucosa, adenoma and malignant lesions.

The registry classes the interventions as drug.

More on the Plan

This study is a prospective experimental study.

Mucosal nerve staining was achieved by endoscopic submucosal injection of methylene blue (MB) solution.

The following features were identified and then compared between normal, adenoma and neoplastic mucosa on magnifying endoscopy images in vivo: nerve morphology (straight or irregular), nerve diameter, branching patterns and nerve density.

Who Took Part

100 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Written informed consent.

The full record lists 2 inclusion and 9 exclusion criteria; among the exclusions: those who are allergic to nerve dye components (such as methylene blue, etc.); complicated with cardiovascular and cerebrovascular diseases, or severely impaired liver, kidney and hematopoietic system; there are hemorrhagic diseases.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Methylene blue (non-peptide stack partner) study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-03-01 with completion listed for 2022-05-01.

It ran at 1 site in China.

Its stated primary purpose is diagnostic.

What Was Measured

Researchers chose this as the main measure: Morphological characteristics of mucosal nerves in different gastrointestinal lesions (time frame: Immediately after operation). Expression levels of PGP9.5, GFAP, VIP, nNOS, TH, ChAT and SOM of different gastrointestinal lesions (time frame: 1 to 3 days after operation).

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Methylene blue (non-peptide stack partner) in 100 people.

Its status is unknown; 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.