Clinical trial NCT05709886: A Prospective, Single-arm, Multicenter Clinical Trial of Safety and Effectiveness of EUS-LA for Liver Cancer
Official title: A Prospective, Single-arm, Multicenter Clinical Trial of Safety and Effectiveness of Endoscopic Ultrasound-guided Laser Ablation for Liver Cancer by LaserPro Diode Laser System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cancer
Keywords: liver cancer
laser
ablation
endoscopic ultrasound
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Yiwu Central Hospital
name: Zhejiang Provincial Tongde Hospital
First posted: 2023-02-02
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To evaluate whether the LaserPro Diode Laser System under the guidance of EUS can achieve the safety and effectiveness of local ablation for liver cancer.
Primary purpose: TREATMENT

Brief 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.

Detailed description: The prospective, single-arm, multi-center clinical trial is to evaluate whether the endoscopic ultrasound (EUS)-guided laser ablation (LA) by LaserPro Diode Laser System can achieve the safety and effectivenessof liver cancer ablation treatment. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. This clinical trial requires 69 subjects. Qualified participants will receive EUS-guided LA by LaserPro Diode Laser System according to the routine procedures. The results will be recorded according to the requirements of the primary outcome (the complete ablation (CA) rate and the effective rate of EUS-guided LA by LaserPro Diode Laser System for liver cancer) and secondary outcomes (technical success rate, major complication rate, partial response rate, secondary ablation rate, progression-free survival (PFS), overall survival rate (OS), local tumor progression (LTP), distant tumor recurrence (DTR), quality of life score and alpha-fetoprotein levels). The one-month follow-up after the operation, three-phase MRI, liver function and tumor markers were reviewed monthly to observe the lesion necrosis and tumor marker changes. After that, tumor markers, three-phase MRI of liver were examined every 2 to 3 months. After then, statistical comparisons of safety and effectivenessof the producedure will be made according to groups.

Eligibility criteria: Inclusion Criteria:

1. Liver malignant tumors with clear histopathology and cytology, or liver malignant tumors that meet clinical diagnosis and staging criteria.
2. Liver tumors within the scope of EUS scanning.
3. 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.
4. Liver function: Child-Pugh A or B.
5. Age: 18-75 years old, regardless of gender.
6. Patients signed informed consent to participate in the trial.

Exclusion Criteria:

1. Contraindication for EUS or the target tumor were beyond the scope of EUS scanning.
2. Liver function: Child-pugh C, those could not improve after liver protective treatment.
3. 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%.
4. Severe failure of major organs such as kidney, heart, lung and brain.
5. Uncontrolled infection in any organ, especially inflammation of the biliary system.
6. Esophageal (bottom of stomach) varices rupture and bleeding within 1 month before treatment.

Primary outcomes:
measure: Complete ablation rate
timeFrame: 1 month
measure: Effectiveness analysis
timeFrame: 6 months
Secondary outcomes:
measure: Technical success rate
timeFrame: 1 month
measure: Major complication rate
timeFrame: 6 months
measure: Partial response rate
timeFrame: 6 months
measure: Secondary ablation rate
timeFrame: 6 months
measure: Progression-free survival (PFS)
timeFrame: 6 months
measure: Overall survival rate (OS)
timeFrame: 6 months
measure: Local tumor progression (LTP)
timeFrame: 6 months
measure: Distant tumor recurrence (DTR)
timeFrame: 6 months
measure: Quality of life score
timeFrame: 6 months
measure: Alpha-fetoprotein levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Zhejiang University
name: Tian'an Jiang, PhD
role: PRINCIPAL_INVESTIGATOR
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