MedTrace Logo

Endoscopic Vital Nerve Staining in Gastrointestinal Diseases

NCT05232357 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-03-15

No results posted yet for this study

Summary

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.

Conditions

  • Gastrointestinal Neoplasms
  • Abnormality of Enteric Nervous System Morphology

Interventions

DRUG

Sodium thiosulfate and Methylene blue solution

Take a methylene blue injection (2ml:20mg), add 18ml distilled water and mix well. Add NaS2O3.5H2O800mg to the methylene blue solution 10ml, add 4 drops of dilute hydrochloric acid, heat the water bath until the dark blue fades, the solution is milky and turbid, adjust the PH to about 3.5. Put the prepared solution into a glass bottle with a rubber stopper, which is wrapped in tin foil, sealed and protected from light, and stored in a refrigerator at-20 ℃. It can be used after high-pressure sterilization before operation. Sodium thiosulfate-Methylene blue (DMB) staining solution was used as nerve staining agent. During gastroenteroscopy, DMB staining solution was locally sprayed on the surface of gastrointestinal lesion mucosa or injected into the lesion mucosa.

Sponsors & Collaborators

  • Affiliated Hospital to Academy of Military Medical Sciences

    lead OTHER

Principal Investigators

  • Yan Liu, MD · Beijing 302 Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-05-01
Completion
2022-05-15

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05232357 on ClinicalTrials.gov