Duodenal protruding lesion or duodenal ampullary lesion
Conditions
Interventions
Experimental group:Use temperature-sensitive endoscopic ultrasound coupling agent
Sponsors
The Second Affiliated Hospital of Army Medical University of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >=18 years, gender unrestricted; 2.Duodenal exophytic lesions or ampullary lesions of the duodenum require endoscopic ultrasound (EUS) examination; 3.Voluntarily accept and comply with this experimental protocol, attend scheduled re-examinations and follow-ups on time, and have signed the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Individuals with severe cardiac disease (NYHA class >= IV), pulmonary disease, or implanted pacemakers who are unable to tolerate upper gastrointestinal endoscopy; 2.Individuals with coagulation dysfunction (prothrombin time >= 18 seconds), those with bleeding disorders, and patients taking oral anticoagulants; 3.Patients with corrosive esophagitis, acute severe pharyngeal diseases, duodenal stenosis, or other conditions where endoscopy cannot be inserted into the duodenum; 4.Individuals unable to tolerate painless endoscopic ultrasonography; 5.Female individuals who were pregnant or lactating at the time of screening; 6.Individuals who participated in other clinical trials within three months prior to the trial; 7.Other conditions deemed unsuitable for inclusion by researchers;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EUS Image Quality Scoring;Incidence and occurrence frequency of adverse reactions during EUS examination; | — |
Secondary
| Measure | Time frame |
|---|---|
| The concordance rate between EUS diagnostic results and postoperative pathological diagnosis;Abdominal pain, diarrhea, abdominal distension, vomiting, cough, fever, and constipation within 24 hours after EUS;Coupling agent/normal saline volume;EUS procedure duration;The frequency of duodenal peristalsis; | — |
Countries
China
Contacts
Public ContactChaoqiang Fan
The Second Affiliated Hospital of Army Medical University of the Chinese People's Liberation Army
Outcome results
None listed