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Trial Title:
A Prospective, Single-arm, Multicenter Clinical Trial of Safety and Effectiveness of EUS-LA for Liver Cancer
NCT ID:
NCT05709886
Condition:
Liver Cancer
Conditions: Official terms:
Liver Neoplasms
Conditions: Keywords:
liver cancer
laser
ablation
endoscopic ultrasound
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
EUS-LA by LaserPro Diode Laser System
Description:
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 (EUS)-guided laser ablation
(LA) 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.
Arm group label:
EUS-LA by LaserPro Diode Laser System
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital, Zhejiang University School of Medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Contact:
Last name:
Tian'an Jiang, PhD
Phone:
86-18857127666
Email:
tiananjiang@126.com
Start date:
February 28, 2023
Completion date:
March 31, 2025
Lead sponsor:
Agency:
First Affiliated Hospital of Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Yiwu Central Hospital
Agency class:
Other
Collaborator:
Agency:
Zhejiang Provincial Tongde Hospital
Agency class:
Other
Source:
First Affiliated Hospital of Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05709886
