Clinical trial NCT05232357: Endoscopic Vital Nerve Staining in Gastrointestinal Diseases
Official title: In Vivo Evaluation of Tumor Neurogenesis in Gastrointestinal Diseases by Topical Submucosal Chromoendoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Gastrointestinal Neoplasms
Abnormality of Enteric Nervous System Morphology
Keywords: Endoscopy
Gastrointestinal Neoplasms
Enteric Nervous System
Gastric nervous system
nerve staining
Methylene blue
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: This study is a prospective experimental study. The baseline data of the patients were recorded objectively: sex, age, vital signs, body weight, some laboratory examination results (blood routine, liver function, blood coagulation function and electrolytes, etc.) and related medical history (comorbidities, treatment history and life history). 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. 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.The aim of this study was to explore the role of MB based topical submucosal chromoendoscopy in the identification of neural architecture and special morphology in normal gastrointestinal mucosa, adenomas and malignant lesions during routine endoscopy.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Written informed consent

Exclusion Criteria:

1. Those who are allergic to nerve dye components (such as methylene blue, etc.)
2. Complicated with cardiovascular and cerebrovascular diseases, or severely impaired liver, kidney and hematopoietic system.
3. Psychopath
4. There are hemorrhagic diseases
5. Platelet count \< 50 × 10 \^ 9 / L
6. Those who are allergic to body mass are
7. Unable to tolerate or cooperate with endoscopy
8. Patients with serious complications, such as severe infection, gastrointestinal bleeding, obstruction and perforation, etc.
9. Pregnant or lactating women

Primary outcomes:
measure: Morphological characteristics of mucosal nerves in different gastrointestinal lesions
timeFrame: Immediately after operation
measure: Expression levels of PGP9.5, GFAP, VIP, nNOS, TH, ChAT and SOM of different gastrointestinal lesions
timeFrame: 1 to 3 days after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: The First Medical Center of Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Beijing 302 Hospital
name: Yan Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: