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Single-center prospective observational study on the application of a novel oral contrast agent for gastrointestinal ultrasonography in the diagnosis of pancreatic space occupying diseases

Single-center prospective observational study on the application of a novel oral contrast agent for gastrointestinal ultrasonography in the diagnosis of pancreatic space occupying diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500096726
Enrollment
Unknown
Registered
2025-02-05
Start date
2024-04-07
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

Pancreatic mass

Interventions

Gold Standard:The gold standard for pancreatic mass-occupying disease is postoperative pathological findings, and MRI and enhanced CT can be used as diagnostic references.
Index test:Ultrasonography with the aid of a new gastrointestinal ultrasound aid.

Sponsors

The First Medical Center of the Chinese People's Liberation Army General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-80 years old; 2. can be fed orally; 3. the patient is admitted to the hospital for surgical treatment of hepatobiliary and pancreatic diseases, and the preoperative diagnosis is obtained by perfecting one of the preoperative imaging diagnosis of enhanced MRI and enhanced CT or by perfecting the preoperative endoscopy and puncture biopsy to obtain the pathology diagnosis. The final pathological diagnosis was obtained by the proposed surgical treatment. The pancreatic occupational group was clinically suspected of diagnosing pancreatic occupational lesions, including pancreatic cancer, pancreatic neuroendocrine tumours, pancreatic solid pseudopapillary tumours, pancreatic cystadenomas, pancreatic intraductal papillomas, and pancreatic pseudocysts; 4. Patients and their family members gave their informed consent to the clinical study and signed the relevant informed consent form.

Exclusion criteria

Exclusion criteria: 1. current clinical situation requires fasting or need to fast to complete other tests; 2. can not be examined before the endurance of fasting 8 hours; 3. previous history of upper gastrointestinal surgery or abdominal wall lesions affecting the ultrasound examination of the patient; 4. allergic to ultrasound co-display agent patients; 5. other physical and mental diseases can not tolerate gastrointestinal ultrasound examination.

Design outcomes

Primary

MeasureTime frame
Display of lesions;Positioning accuracy;Diagnostic accuracy;specificity;Area under the ROC curve;

Secondary

MeasureTime frame
sensitivity;

Countries

China

Contacts

Public ContactChangtian Li

The First Medical Center of the Chinese People's Liberation Army General Hospital

liction4995@163.com+86 158 0118 9525

Outcome results

None listed

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