Endoscopic Vital Nerve Staining in Gastrointestinal Diseases
Primary Purpose
Gastrointestinal Neoplasms, Abnormality of Enteric Nervous System Morphology
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Sodium thiosulfate and Methylene blue solution
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastrointestinal Neoplasms focused on measuring Endoscopy, Gastrointestinal Neoplasms, Enteric Nervous System, Gastric nervous system, nerve staining, Methylene blue
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- The First Medical Center of Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endoscopic nerve staining
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05232357
First Posted
January 5, 2022
Last Updated
February 28, 2022
Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05232357
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
May 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital to Academy of Military Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Neoplasms, Abnormality of Enteric Nervous System Morphology
Keywords
Endoscopy, Gastrointestinal Neoplasms, Enteric Nervous System, Gastric nervous system, nerve staining, Methylene blue
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endoscopic nerve staining
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sodium thiosulfate and Methylene blue solution
Other Intervention Name(s)
NaS2O3.5H2O and Methylene blue injection (2ml:20mg)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Morphological characteristics of mucosal nerves in different gastrointestinal lesions
Description
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.
Time Frame
Immediately after operation
Title
Expression levels of PGP9.5, GFAP, VIP, nNOS, TH, ChAT and SOM of different gastrointestinal lesions
Description
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.
Time Frame
1 to 3 days after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Liu, MD
Phone
+8613911798288
Email
13911798288@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Wu, MD
Phone
+8618110076598
Email
wuliangdoc@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Liu, MD
Organizational Affiliation
Beijing 302 Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Medical Center of Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Liu
Phone
+8613911798288
Email
13911798288@163.com
First Name & Middle Initial & Last Name & Degree
Yan Liu
12. IPD Sharing Statement
Plan to Share IPD
No
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Endoscopic Vital Nerve Staining in Gastrointestinal Diseases
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