Endoscopic Vital Nerve Staining in Gastrointestinal Diseases

NCT05232357 | Unknown Early Phase 1

• 1 other identifier: Endoscopic nerve staining
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Endoscopy; Gastrointestinal Neoplasms; Enteric Nervous System; Gastric nervous system; nerve staining; Methylene blue

Outcome Measures

Primary Outcomes (2)

• Morphological characteristics of mucosal nerves in different gastrointestinal lesions

  Mucosal nerve staining was achieved by endoscopic submucosal injection of 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.

  Immediately after operation

• Expression levels of PGP9.5, GFAP, VIP, nNOS, TH, ChAT and SOM of different gastrointestinal lesions

  Immunohistochemistry was used to further confirm the presence and to study the morphology of neural structures (PGP9.5 and GFAP staining) and neural attribute (VIP, nNOS, TH, ChAT and SOM staining) on tumor, adenoma and normal mucosal sections.

  1 to 3 days after operation

Study Arms (1)

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.

Drug: Sodium thiosulfate and Methylene blue solution

Interventions

Sodium thiosulfate and Methylene blue solution DRUG

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.

Also known as: NaS2O3.5H2O and Methylene blue injection (2ml:20mg)

Endoscopic nerve staining

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis or suspected diagnosis of one of the following common gastrointestinal diseases: chronic non-atrophic gastritis, chronic atrophic gastritis, gastric polyps, gastric early cancer, advanced gastric cancer; colonic polyps, colonic Melanosis, early colon cancer, advanced colon cancer
• Written informed consent

You may not qualify if:

• 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.
• Psychopath
• There are hemorrhagic diseases
• Platelet count \< 50 × 10 \^ 9 / L
• Those who are allergic to body mass are
• Unable to tolerate or cooperate with endoscopy
• Patients with serious complications, such as severe infection, gastrointestinal bleeding, obstruction and perforation, etc.
• Pregnant or lactating women

Sponsors & Collaborators

• Affiliated Hospital to Academy of Military Medical Sciences: lead

Study Sites (1)

The First Medical Center of Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

sodium thiosulfate; Methylene Blue

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yan Liu, MD

  Beijing 302 Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Liu, MD

CONTACT

+8613911798288; 13911798288@163.com

Liang Wu, MD

CONTACT

+8618110076598; wuliangdoc@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 9, 2022
• Study Start: March 1, 2022
• Primary Completion: May 1, 2022
• Study Completion: May 15, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)