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Clinical research on the accurate recognition and rapid auxiliary diagnosis system of pancreatic benign and malignant tumors with harmonic contrast enhanced ultrasound endoscopy based on deep learning

Clinical research on the accurate recognition and rapid auxiliary diagnosis system of pancreatic benign and malignant tumors with harmonic contrast enhanced ultrasound endoscopy based on deep learning

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000040056
Enrollment
Unknown
Registered
2020-11-19
Start date
2020-11-15
Completion date
Unknown
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pancreatic solid masses

Interventions

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Gold Standard:A. For patients undergoing surgery, the final diagnosis is the pathology of surgically removed specimens B. The EUS-FNA result is malignant, and the final diagnosis is malignant
C. In the absence of surgical pathology and negative EUS-FNA results, at least 8 months of clinical follow-up will be performed to
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Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 90 years old; 2. The patient is confirmed to be a solid pancreatic mass in imaging examinations (MRI, CT or ultrasound), and CH-EUS is required for auxiliary diagnosis; 3. Agree to participate in this study and sign the CH-EUS informed consent form.

Exclusion criteria

Exclusion criteria: Subjects who meet any of the following criteria cannot be selected for this trial: 1. The patients physical condition does not meet the requirements of conventional ultrasound endoscopic puncture: (1) Poor physical condition, including hemoglobin 1.5) or taking oral anticoagulants such as aspirin or warfarin within a week; (3) Anesthesia assessment failed; (4) Had acute pancreatitis within 2 weeks; (5) Pregnancy or breastfeeding; (6) Known history of allergy to sulfur hexafluoride or other components; (7) Recent acute coronary syndrome or clinically unstable ischemic heart attack; (8) Heart disease patients with right-to-left shunt, patients with severe pulmonary hypertension (pulmonary artery pressure> 90mmHg), patients with uncontrolled systemic hypertension and patients with adult respiratory distress syndrome; 2. Disagree to participate in this study; 3. There are other problems that do not meet the requirements of this research or that affect the results of the research: (1) Pancreatic disease has undergone surgery or chemotherapy beforehand; (2) The patient was diagnosed with pancreatic cystic disease or duodenal stenosis; (3) Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up.

Design outcomes

Primary

MeasureTime frame
Accuracy;Sensitivity;Specificity;positive predictive value;negative predictive value;

Secondary

MeasureTime frame
the diagnosis rate of first needle aspiration;core tissue length;

Countries

China

Contacts

Public ContactXiaoyan Wang

Department of gastroenteropathy, The Third Xiangya Hospital of Central South University

wxy20011@163.com+86 13974889301

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026