Clinical trial NCT02728167: Efficacy of HIFU-AR on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Metastasis
Keywords: Hepatectomy
Liver metastasis
High-Intensity Focused Ultrasound
Liver metastases (LM) requiring surgery
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2016-04-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Normalized blood loss (ml/cm2)
timeFrame: During hepatectomy
Secondary outcomes:
measure: Total blood los (ml)
timeFrame: During hepatectomy
measure: Transection time
timeFrame: During hepatectomy
measure: Transection time/cm2 of liver area (min/cm2)
timeFrame: During hepatectomy
measure: Hemostasis time
timeFrame: During hepatectomy
measure: Clip density on the liver section area
timeFrame: During hepatectomy
measure: Rate of Pringle manoeuvre
timeFrame: During hepatectomy
measure: Rate of patients needing a blood transfusion
timeFrame: During hepatectomy
measure: Length of hospital stay
timeFrame: 10 days
measure: Number of patients with postoperative complications assessed using Dindo-Clavien classification
timeFrame: 6 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Bérard
name: Michel RIVOIRE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dupre A, Perol D, Blanc E, Peyrat P, Basso V, Chen Y, Vincenot J, Kocot A, Melodelima D, Rivoire M. Efficacy of high-intensity focused ultrasound-assisted hepatic resection (HIFU-AR) on blood loss reduction in patients with liver metastases requiring hepatectomy: study protocol for a randomized controlled trial. Trials. 2017 Feb 6;18(1):57. doi: 10.1186/s13063-017-1801-2.