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NCT05709886
A Prospective, Single-arm, Multicenter Clinical Trial of Safety and Effectiveness of EUS-LA for Liver Cancer
Conditions: Liver Cancer
Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 69
Sponsor: First Affiliated Hospital of Zhejiang University
Location: China
Summary
This trial is a prospective, single-arm, multi-center clinical trial.
Four hospitals with national medical trial institution qualifications are selected as clinical trial centers.
Qualified participants will receive endoscopic ultrasound-guided laser ablation by LaserPro Diode Laser System according to the routine procedures.
The results will be recorded according to the requirements of the primary and secondary efficacy indicators.
After then, statistical comparisons of effectiveness and safety of the procedure will be made according to groups.
Eligibility Criteria
Inclusion Criteria:Liver malignant tumors with clear histopathology and cytology, or liver malignant tumors that meet clinical diagnosis and staging criteria.Liver tumors within the scope of EUS scanning.Single tumor≤ 3cm in diameter and the number of visible tumor were no more than 3.
According to CT and MRI, there are no macrovascular and bile duct invasions visible by the naked eye.Liver function: Child-Pugh A or B.Age: 18-75 years old, regardless of gender.Patients signed informed consent to participate in the trial.Exclusion Criteria:Contraindication for EUS or the target tumor were beyond the scope of EUS scanning.Liver function: Child-pugh C, those could not improve after liver protective treatment.Uncorrectable coagulation dysfunction and severe haematological abnormalities, who tend to severe bleeding; platelet count less than 50×109/L, prothrombin time more than 30s or prothrombin activity less than 40%.Severe failure of major organs such as kidney, heart, lung and brain.Uncontrolled infection in any organ, especially inflammation of the biliary system.Esophageal (bottom of stomach) varices rupture and bleeding within 1 month before treatment.
Source: ClinicalTrials.gov (NCT05709886). StuddyBuddy aggregates publicly available trial information.