Histotripsy (HistoSonics®) for Liver Tumours

Not Applicable

Active, not recruiting

• Conditions: Liver Tumour
• Interventions: Radiation: Histotripsy

• Registration Number: NCT06579833
• Lead Sponsor: The University of Hong Kong

Brief Summary

Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures. It works by using high-intensity ultrasound waves to create microscopic bubbles within the tumour tissue. These bubbles rapidly expand and collapse, generating shock waves that disrupt the tissue. The technique is highly precise and can be targeted to specific areas of the liver, allowing for selective destruction of tumour cells while minimizing damage to healthy tissue. This study will enrol 20 patients with liver tumours (be it primary or secondary liver tumours), monitor their post-operative adverse events, and study the changes in tumour size and volume after treatment. Histotripsy will be performed under general anaesthesia, with real-time monitoring by ultrasound, and deliver high-intensity ultrasound waves in single session or multiple sessions. Similar to other minimal invasive treatments, patients will be admitted 1 day prior, then receive Histotripsy on the next day and stay overnight for observation. Patients will be discharged on the 3rd day if unremarkable. During the hospital stay, blood samplings will be taken for evaluation around 2-4 times in total depending on the length of hospital stay.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-13
• Study Start: 2024-08-29
• Study First Submitted QC: 2024-08-29
• Study First Posted: 2024-08-30
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-16
• Primary Completion: 2027-09-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Fit for general anaesthesia
• Liver tumour size < 10cm
• Solitary or multifocal
• Primary liver tumour such as hepatocellular carcinoma or intrahepatic cholangiocarcinoma
• Secondary liver tumour such as liver metastasis
• Patients with operable or inoperable liver tumours
• Liver transplant candidates awaiting for liver graft

Exclusion Criteria

• Refusal to take part in clinical trial
• Child C liver cirrhosis
• Not fit for general anaesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Histotripsy	Histotripsy	Histotripsy is a promising non-invasive technique that uses high-intensity ultrasound waves to disrupt tissue without damaging surrounding structures

Primary Outcome Measures

Name	Time	Method
Changes in tumour features	up to 36 months	Changes in tumour size and volume before and after intervention
Post procedure adverse events and complication	The whole duration of hospital stay, normally 3 days on average	Post procedure adverse events and complication

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong