Clinical trial NCT06195917: Robotic-assisted Percutaneous Transhepatic Puncture
Official title: Evaluation of the Safety, Effectiveness and Usability of Robotic-assisted Interventional Percutaneous Transhepatic Puncture: A First-in-human Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Liver Diseases
Lead sponsor: Zhongda Hospital
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a first-in-man study to investigate the feasibility and safety profile of the newly developed robotic system for percutaneous transhepatic interventional procedures, including biopsy and ablation. Participants who were clinically assessed in need of a liver lesion puncture were included in this study.

Detailed description: In current clinical practice, surgeons mainly use personal experience as a judgment criterion to determine the insertion Angle and trajectory of the needle path. In the process of puncture surgery, surgeons will complete the positioning puncture in three-dimensional space based on the guidance of two-dimensional images and personal judgment. Among them, the lack of three-dimensional sense of space in two-dimensional images may cause inaccurate positioning of the puncture needle in three-dimensional space, and even lead to the deviation of the needle tip approach, resulting in inaccurate biopsy sampling or inaccurate anastomosis in the simulation of thermal field before ablation. In addition, during surgery, changes in the patient's own gravity, breathing movements, posture, or the application of force during needle insertion may cause soft tissue displacement, thereby reducing the accuracy of positioning. In general, in order to ensure the accuracy of puncture, doctors will insert needles repeatedly and perform multiple CT scans on patients, which will lead to low surgical efficiency, increased risk of puncture complications, and increased trauma and pain of patients. In addition, in the puncture operation for liver tumors, if the needle insertion path is not accurate and the needle path is adjusted repeatedly, the risk of the puncture needle carrying out tumor cells will increase, which may cause the metastasis and spread of cancer cells, which is also a big challenge for young doctors. The investigators aim to evaluate the safety, effectiveness and usability of robotic-assisted percutaneous transhepatic puncture in this prospective study.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older, with no gender restrictions. (2) clinically assessed and deemed in need of a liver lesion puncture. (3) with a intrahepatic lesion no less than 1 cm in diameter. (4)with liver function of Child-Pugh Class A or B. (5) agree to participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

1. with severe liver cirrhosis or in a decompensated liver function state within the 3 months prior to screening and who have undergone abdominal paracentesis for the treatment of a large amount of ascites.
2. with severe coagulation disorders during the screening period, characterized by a platelet count \< 50×10\^9/L, a prolonged PT time \> 6s, and an international normalized ratio (INR) \> 1.5.
3. classified as NYHA heart function Grade III and IV during the screening period.
4. with severe chronic obstructive pulmonary disease (COPD) or severe asthma during the screening period.
5. with renal insufficiency during the screening period, defined by creatinine (Cr) or blood urea nitrogen (BUN/UREA) levels exceeding two times the upper limit of normal.
6. unable to cooperate with surgical positioning and other requirements for surgery.
7. Pregnant or lactating women of childbearing age and other vulnerable groups.
8. have participated in other interventional clinical trials within the month prior to the commencement of this trial.
9. Other individuals who are deemed unsuitable for participation in this trial by the investigator.

Primary outcomes:
measure: One-time puncture success rate
timeFrame: one day
Secondary outcomes:
measure: Number of puncture attempts
timeFrame: one day
measure: Puncture accuracy
timeFrame: one day
measure: Planning time
timeFrame: one day
measure: Instrument performance evaluation
timeFrame: one day
measure: Incidence of adverse events
timeFrame: three days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Centre of Interventional Radiology and Vascular Surgery, Department of Radiology, Zhongda Hospital, Southeast University
state: Jiangsu
Study officials:
affiliation: Zhongda Hospital
name: Jian Lu, MD
role: PRINCIPAL_INVESTIGATOR
References: