Clinical trial NCT06236594: Application of Multimodal Endoscopic Functional Imaging Technology in the Diagnosis of Common Gastrointestinal Diseases
Official title: Application of Multimodal Endoscopic Functional Imaging Technology in the Diagnosis of Common Gastrointestinal Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastrointestinal Disease
Keywords: endoscopic laser speckle imaging
multispectral blood oxygen imaging
gastrointestinal lesions
early diagnosis
gastrointestinal tumors
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Meet the inclusion and exclusion criteria.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Image quality rate
timeFrame: one year
Secondary outcomes:
measure: Diagnosis accuracy according to image
timeFrame: one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: The fifth Medical Center of Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Beijing 302 Hospital
name: Yan Liu
role: PRINCIPAL_INVESTIGATOR
References: