Application of Multimodal Endoscopic Functional Imaging Technology in the Diagnosis of Common Gastrointestinal Diseases

Recruiting

• Conditions: Gastrointestinal Disease

• Registration Number: NCT06236594
• Lead Sponsor: Beijing 302 Hospital

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.

Study Timeline

• Study Start: 2023-09-18
• Status Verified: 2024-01
• Study First Submitted: 2024-01-24
• Study First Submitted QC: 2024-01-24
• Last Update Submitted: 2024-01-24
• Study First Posted: 2024-02-01
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Image quality rate	one year	The main evaluation index (image quality rate) is based on FAS(Full Analysis Set) and PPS(Per Protocol Set), for statistical description. Image quality rate Calculation formula: image excellent rate = number of cases with excellent or good image quality evaluation ÷ number of subjects undergoing multimodal endoscopy × 100%.

Secondary Outcome Measures

Name	Time	Method
Diagnosis accuracy according to image	one year	(1) Endoscopy examinations combined with laser speckle imaging and Doppler blood oxygen imaging can realize multi-level vascular observation and photographing of the mucosa, and the imaging analyzer will analyzes and synthesizes the two-dimensional map of laser speckle and blood oxygen imaging of the mucosa. Endoscopist will make diagnosis according to the image they get. (2) After endoscopic biopsy or endoscopic mucosal resection (EMR), endoscopic submucosal resection (ESD) obtaining tissue specimens, the pathology was observed by conventional HE staining or immunohistochemistry. (3) The results of comparison are divided into conformity, partial conformity and non-conformity.

Trial Locations

Locations (1)

The fifth Medical Center of Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China