Deep Learning-Based Confocal Laser Microendoscopy Feature Atlas Construction and Its Application in Intelligent Diagnosis of Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Evaluation of the accuracy and inter-evaluator agreement of the constructed IBS diagnostic model with the diagnostic results of the Rome IV criteria.
研究概览
简要总结
In this study, the healthy control group and IBS patients are taken as the research subjects, and CLE is applied to image and analyze the enrolled persons respectively, to derive and compare the characteristic microstructural images of the healthy control group with those of the IBS patients, to establish a diagnostic model of IBS by using deep learning and to evaluate the diagnostic efficacy of the model for IBS.Participants will undergo colonoscopy and confocal laser microendoscopy, and IBS patients will undergo targeted biopsy in CLE to observe suspicious lesions and lesion margins, and specimens will undergo HE staining and immunohistochemistry testing.
Translated with DeepL.com (free version)
详细描述
The study is prospective, observational, and diagnostic.
Research methodology Equipment Consumables The equipment consumables used include a colonoscopy operating system, pCLE system, fluorescein sodium injection, and single-use endoscopic biopsy forceps.
Phase 1 Endoscopy All enrolled person receive fluorescein sodium allergy test before pCLE examination, and fluorescein sodium is injected intravenously after observing no allergic reactions such as dizziness, rash, itching, shock, etc. for 15 min. 30 s later, the pCLE probe is placed from the biopsy clamp channel of enteroscopy, and six different intestinal segments of the cecum, ascending colon, transverse colon, descending colon, sigmoid colon, and rectum are examined in order and the images are collected, and each intestinal segment of the pCLE of all person is recorded continuously with 3-minute video recordings (operation is kept within 30 min after the procedure). and more than 4000 images are recorded for each person. During the operation, the probe is gently placed on the mucosal surface and kept as perpendicular to the bowel wall as possible, and the movements are gentle, slow, and soft to avoid mucosal injury. The endoscopist is performing targeted biopsies of all suspicious lesions and lesion margins observed in pCLE.
Pathological analysis After the specimens are fixed in formalin solution and embedded in paraffin, 2 sections with a thickness of 4 μm are cut. The first section is stained with HE to evaluate the mild inflammation of the intestine; the second section is stained with immunohistochemistry to evaluate the mast cell markers and tight junction proteins in the intestinal wall.
Screening of characteristic pCLE images All videos are measured and analyzed by the same experienced endoscopist, after screening all images with good stability, no artifacts, and clear display of microstructures. pCLE images are characterized by a ruler of 10 μm in length in the lower left corner, which allows real-time evaluation of a number of parameters in real time during the operation. Image J image analysis software is used to measure capillary diameter (CD), cell spacing (CS), gland spacing (GS), gland area (GA), and whether sodium fluorescein leak into the crypt lumen in the pCLE field of view. and other indicators. The images are categorized according to the healthy control group and the IBS patient group, and the characteristic images of each group are formed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •①Healthy control group and test group of IBS with clear clinical diagnosis (Rome IV diagnostic criteria). Healthy controls are free of gastrointestinal symptoms, test results (blood count, CRP, ESR, etc.) and colonoscopy abnormalities.Patients with IBS have recurrent abdominal pain (≥1 day per week on average in the past 3 months), with onset ≥6 months before diagnosis, and the abdominal pain is accompanied by at least two of the following three symptoms: pain related to defecation, change in stool frequency, and change in the shape (appearance) of the feces, and other organic or metabolic disorders are excluded.② Age: between 18 and 80 years old.③ Probe-based confocal Laser Endomicroscopy (pCLE) is required, and patients have good compliance. ④ Normal coagulation function, and biopsies can be obtained for pathological examination.⑤ Voluntary signing of informed consent.
排除标准
- •Fluorescein sodium allergy. ②Contraindications to colonoscopy (pregnant or breastfeeding patients, uncooperative psychiatric patients with severe mental disorders, colonic obstruction) or inadequate bowel preparation (Boston Bowel Preparedness Scale score of <2 for any colonic segment).③ Comorbidities with major organ dysfunction (with severe cardiopulmonary disease) or impaired renal function (blood creatinine >450umol/L). ④ Other conditions that, in the judgment of the investigator, make it unsuitable for participation in the study (inflammatory bowel disease, infected IBS, having taken nonsteroidal anti inflammatory drugs, corticosteroids or antibiotics within the last year, etc.).
结局指标
主要结局
Evaluation of the accuracy and inter-evaluator agreement of the constructed IBS diagnostic model with the diagnostic results of the Rome IV criteria.
时间窗: Approximately 15 months from completion of image collection, analysis, deep learning and construction of IBS diagnostic model to validation of diagnostic model performance.
Diagnostic model constructed from CLE-based image data and multimodal model constructed from fused image joint text data
次要结局
未报告次要终点
研究者
Kaijun Liu
MD, Ph.D,Associate Professor, Associate Chief Physician
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
