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Trial Title:
Application of Multimodal Endoscopic Functional Imaging Technology in the Diagnosis of Common Gastrointestinal Diseases
NCT ID:
NCT06236594
Condition:
Gastrointestinal Disease
Conditions: Official terms:
Gastrointestinal Diseases
Digestive System Diseases
Conditions: Keywords:
endoscopic laser speckle imaging
multispectral blood oxygen imaging
gastrointestinal lesions
early diagnosis
gastrointestinal tumors
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
We plan the study to explore the application of endoscopic laser speckle imaging and
multispectral blood oxygen imaging to observe gastrointestinal lesions, as well as the
differences in the morphology, density and functional status of mucosal surfaces and deep
blood vessels of different gastrointestinal lesions, also to explore the role of
endoscopic multimodal functional imaging in common gastrointestinal diseases, especially
in the early diagnosis of gastrointestinal tumors.
Detailed description:
The current focus of electronic endoscopy is on the morphology and fine structure of the
mucosal surface, and there is no effective observation method for the deep structure of
the mucosa and the function of blood oxygen binding. However, the multilayer morphology
and functions of mucosal vessels under different conditions of digestive tract lesions
should be different. Therefore, we propose a method of endoscopic multimodal functional
imaging to the conventional endoscopic examinations observing the mucosa of the digestive
tract, which is based on the existing electronic endoscope, laser speckle contrast
imaging and multispectral blood oxygen imaging technology. Laser irradiation was given to
obtain the information of coherent light on the mucosal surface and deep scattering of
coherent light to obtain multi-level vascular distribution information, and multispectral
irradiation imaging was carried out to obtain the oxygenation situation of the mucosa.
Finally, we may find the differences of images of deep blood vessels among common
gastrointestinal diseases, which could help us to make early diagnosis of
gastrointestinal tumors noninvasively.
Criteria for eligibility:
Study pop:
Meet the inclusion and exclusion criteria.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Age: 18-80 years old, gender is not limited
2. Diagnosed or suspected of one of the following common gastrointestinal mucosal
diseases: Chronic non-atrophic gastritis, chronic atrophic gastritis, gastric
polyps, early gastric cancer, advanced gastric cancer, colon polyps, colon
melanosis, inflammatory bowel disease, early colon cancer, advanced colon cancer
3. Sign the informed consent form -
Exclusion Criteria:
1. Combined with cardiovascular and cerebrovascular diseases, or severe impairment of
liver, kidney and hematopoietic system;
2. mentally ill;
3. the presence of bleeding disorders;
4. Platelet count<50×10^9/L;
5. Inability to tolerate or cooperate with endoscopy;
6. Patients with serious complications, such as severe infection, gastrointestinal
bleeding, obstruction, perforation, etc.;
7. Pregnant or lactating women.
8. Refuse to sign the informed consent form
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The fifth Medical Center of Chinese PLA General Hospital
Address:
City:
Beijing
Zip:
100071
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Shen
Phone:
+8615001038695
Email:
shshenw@sina.com
Contact backup:
Last name:
Shujuan Li
Phone:
+8601066947300
Investigator:
Last name:
Yan Liu
Email:
Principal Investigator
Start date:
September 18, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Beijing 302 Hospital
Agency class:
Other
Source:
Beijing 302 Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06236594
