title: First clinical experience of intra-operative high intensity focused ultrasound in patients with colorectal liver metastases: a phase I-IIa study.
abstract: BACKGROUND
  Surgery is the only curative treatment in patients with colorectal liver metastases (CLM), but only 10-20% of patients are eligible. High Intensity Focused Ultrasound (HIFU) technology is of proven value in several indications, notably prostate cancer. Its intra-operative use in patients with CLM has not previously been studied. Preclinical work suggested the safety and feasibility of a new HIFU device capable of ablating volumes of up to 2cm x 2cm in a few seconds.
  
  
  METHODS
  We conducted a prospective, single-centre phase I-IIa trial. HIFU was delivered immediately before scheduled hepatectomy. To demonstrate the safety and efficacy of rapidly ablating liver parenchyma, ablations were performed on healthy tissue within the areas scheduled for resection.
  
  
  RESULTS
  In total, 30 ablations were carried out in 15 patients. These ablations were all generated within 40 seconds and on average measured 27.5mm x 21.0mm. The phase I study (n = 6) showed that use of the HIFU device was feasible and safe and did not damage neighbouring tissue. The phase IIa study (n = 9) showed both that the area of ablation could be precisely targeted on a previously implanted metallic mark (used to represent a major anatomical structure) and that ablations could be undertaken deliberately to avoid such a mark. Ablations were achieved with a precision of 1-2 mm.
  
  
  CONCLUSIONS
  HIFU was feasible, safe and effective in ablating areas of liver scheduled for resection. The next stage is a phase IIb study which will attempt ablation of small metastases with a 5 mm margin, again prior to planned resection.
  
  
  BACKGROUND
  ClinicalTrials.govNCT01489787.
authors.affiliation: Department of Surgical Oncology, Centre Léon Bérard, Lyon, France; LabTau, U1032, Inserm, Université de Lyon, Lyon, France.
authors.forename: Aurélien
authors.initials: A
authors.lastname: Dupré
authors.affiliation: LabTau, U1032, Inserm, Université de Lyon, Lyon, France.
authors.forename: David
authors.initials: D
authors.lastname: Melodelima
authors.affiliation: Biostatistics and Treatment Evaluation Unit, Centre Léon Bérard, Lyon, France.
authors.forename: David
authors.initials: D
authors.lastname: Pérol
authors.affiliation: Department of Surgical Oncology, Centre Léon Bérard, Lyon, France.
authors.forename: Yao
authors.initials: Y
authors.lastname: Chen
authors.affiliation: LabTau, U1032, Inserm, Université de Lyon, Lyon, France.
authors.forename: Jérémy
authors.initials: J
authors.lastname: Vincenot
authors.affiliation: LabTau, U1032, Inserm, Université de Lyon, Lyon, France.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Chapelon
authors.affiliation: Department of Surgical Oncology, Centre Léon Bérard, Lyon, France; LabTau, U1032, Inserm, Université de Lyon, Lyon, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Rivoire
mesh_terms: D000328:Adult; D000368:Aged; D015179:Colorectal Neoplasms / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D005260:Female; D006498:Hepatectomy / Q000009:adverse effects / Q000379:methods; D057086:High-Intensity Focused Ultrasound Ablation / Q000009:adverse effects* / Q000379:methods; D006801:Humans; D007432:Intraoperative Period; D008113:Liver Neoplasms / Q000556:secondary / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged