Efficacy of HIFU-AR on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy

Liver Metastasis Clinical Trial

— HIFU-AR  

Official title:

Randomized, Open-label, Phase II Study to Evaluate the Efficacy of High-Intensity Focused Ultrasound Assisted Hepatic Resection (HIFU-AR) on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02728167
• Other study ID #: HIFU-AR
• Status: Terminated
• Phase: N/A
• Start date: April 2016
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether HIFU-assisted liver resection (HIFU-AR) results in reduced blood loss compared to standard liver resection in patients with LM.This is a prospective, monocentric, randomized (1:1 ratio), comparative, open-label Phase II study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: August 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years at the day of consenting to the study.

• Patients with liver metastases requiring a hepatectomy for = 2 segments.

• ECOG PS = 1.

• Adequate bone marrow and liver function at baseline as defined below:

• Platelet count = 100 x 109/l, and hemoglobin of = 9 g/dl),

• Total bilirubin = 1.5 x ULN, AST and ALT = 5 x ULN.

• Recovered from prior anti-neoplasic treatment-related toxicity (grade <2 persistent treatment-related toxicity as per CTCAE v4 are accepted).

• Willingness for follow-up visits.

• Covered by a medical insurance.

• Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.

Exclusion Criteria:

• Patients having previously undergone

• a major hepatic surgery (i.e. more than 3 liver segments) or

• biliary major surgery.

• Patient with cirrhosis or sinusoidal obstruction syndrome with portal hypertension.

• Pregnant women (women of childbearing potential are required to have a negative pregnancy test within 72 hours prior to inclusion). A positive urine test must be confirmed by a serum pregnancy test.

Related Conditions & MeSH terms

• Liver Metastasis
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

Device:
• Pre-coagulation of the liver parenchyma with HIFU
6 to 10 (or more if necessary) side-to-side 40-seconde HIFU treatments

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normalized blood loss (ml/cm2)	To compare the blood loss during hepactectomy in patients treated by HIFU-AR versus standard liver resection	During hepatectomy
Secondary	Total blood los (ml)		During hepatectomy
Secondary	Transection time		During hepatectomy
Secondary	Transection time/cm2 of liver area (min/cm2)		During hepatectomy
Secondary	Hemostasis time		During hepatectomy
Secondary	Clip density on the liver section area	Number of clips/cm2	During hepatectomy
Secondary	Rate of Pringle manoeuvre		During hepatectomy
Secondary	Rate of patients needing a blood transfusion		During hepatectomy
Secondary	Length of hospital stay		10 days
Secondary	Number of patients with postoperative complications assessed using Dindo-Clavien classification		6 months