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Not yet recruitingNCT07873619Updated Oct 14, 2026

Histotripsy for Peritoneal Tumour and Lymph Node: a Pilot Study

An interventional study of Histotripsy in Lymph Nodes and Peritoneal Tumour, sponsored by The University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by The University of Hong Kong · Not applicable, Interventional, and Treatment

Updated Oct 14, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Peritoneal cancer is tricky to be managed. It is not easy to be detected or diagnosed at early stage without symptom, or with common symptoms of many diseases or discomfort and often leads to advance stage at time of diagnosis with few treatment options and limited life span. It is also challenging to handle peritoneal tumour as it usually involves large area in peritoneum, or spread widely throughout the surface of peritoneum if metastatic from other origins. Systemic therapy is the common way to treat peritoneal cacner if the disease is inoperable. However, the unsatisfied penetration rate significantly limits the anti-tumour effect of intraperitoneal chemotherapy even after various attempts and most approaches demonstrated limited efficiency. Effective treatment for peritoneal cancer is still scarce and necessary. While the tumour nature of peritoneal tumour consists of solid tumour and soft tissue tumour, depends on primary or secondary disease, Histotripsy, which can be used on most kinds of solid tumour as well as soft tissue tumour, may yield a new direction and insight on peritoneal cancer management.

Histotripsy is currently indicated for liver tumours, approved by FDA and has been investigated for many disease types in preclinical researches and carried out several clinical trials for liver tumour, benign prostatic hyperplasia, liver tumour combined with systemic therapy, renal tumour, pancreatic tumour, soft tissue tumours, abdominal tumour, calcific aortic valves, and pain in plantar fasciitis, with encouraging results in some clinical trials. As most clinical trials above are for solid tumour and soft tissue tumour that suit the tumour nature of peritoneal tumour, we believe that Histotripsy is also safe and feasible on human with peritoneal tumour. Considering nodal involvement also frequently comes with peritoneal cancer, we would like to conduct an investigation for Histotripsy in peritoneal tumour and lymph node.

Although the result of clinical trial in peritoneal tumour and lymph node are not available yet, HIFU (High Intensity Focused Ultrasound) as another non-invasive ablation also delivered by ultrasound wave which has been in clinical use for many years worldwide can be referenced for Histotripsy. The core difference of HIFU and Histotripsy is, HIFU employs thermal energy to induce coagulative necrosis, while Histotripsy utilises mechanical cavitation to disrupt tumour tissues and preserves adjacent critical structure without the issue of heat, which makes it safer than HIFU. According to some reviews of HIFU, it is obvious that HIFU is feasible and safe without significant adverse event for abdominal tumours including peritoneal tumour and lymph node. Consequently, Histotripsy as a non-thermal ablation and is considered to be safer than HIFU, should also be feasible and safe for peritoneal tumour and lymph node. Hence, it is time for Hong Kong to launch the investigation on the feasibility, safety, and efficacy of Histotripsy in peritoneal tumour and lymph node.

02

Conditions studied

  • Lymph Nodes
  • Peritoneal Tumour

Keywords

  • peritoneal tumour
  • peritoneal cancer
  • lymph node
  • nodal metastasis
  • peritoneal metastasis
  • histotripsy
03

In context

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,286 studies on the registry; 343 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years old
  • Fit for general anaesthesia
  • Peritoneal tumour (eg. intraperitoneal tumour, retroperitoneal tumour) and/or lymph node
  • Size ≤ 10cm for each peritoneal tumour and lymph node
  • With or without distant metastasis
  • Good performance status

    1. Tumour visible and targetable by ultrasound with acceptable acoustic windows
    2. Adequate hematologic, hepatic, and renal function

Exclusion criteria

Exclusion Criteria:

  • Refusal to take part in clinical trial
  • Not fit for general anaesthesia
  • Poor general condition with limited life expectancy
  • Uncontrolled coagulopathy
  • Extensive bowel interposition preventing safe targeting, per recent porcine safety data linking mis-targeting to bowel injury
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Histotripsy

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

    Radiation: Histotripsy

Interventions

  • RadiationHistotripsy

    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.

06

What researchers measure

Primary outcomes

  1. number of case proceed with Histotripsy

    feasibility of doing histotripsy for peritoneal tumour and/or lymph nodes

    Time frame: 1 day after procedure

  2. post procedure events

    safety monitoring

    Time frame: duration of hospital stay, normally 3 days on average

  3. changes in tumour features

    changes in tumour size with serial interval scans

    Time frame: up to 3 years

Secondary outcomes

  1. Questionnaire based pain assessment

    to evaluate patient-reported pain level before and after Histotripsy

    Time frame: 2 days

07

Study locations

1 site
  • The University of Hong Kong
    Hong Kong, 0000, Hong Kong
    • Albert Chan, MBBS, MS · Contact · acchan@hku.hk · +85222553025
    • Albert Chan, MBBS, MS · Principal investigator
    • Vince Lau, MBBS · Sub investigator
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07873619
Responsible party
Albert Chi Yan Chan (Clinical Professor, The University of Hong Kong) — Principal investigator
First posted
Oct 14, 2026
Start date
Oct 1, 2026 (estimated)
Primary completion
Aug 31, 2029 (estimated)
Completion
Aug 31, 2029 (estimated)
Last update
Oct 14, 2026

Study contacts

Albert Chan, MBBS, MS
Contact
acchan@hku.hk
+85222553025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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