A Phase I-II Study to Evaluate, in Patients Operated for a Hepatic Resection of Colorectal Liver Metastases, a High Intensity Focused Ultrasound (HIFU) Procedure: Feasibility, Safety and Accuracy.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Centre Leon Berard
- Enrollment
- 38
- Locations
- 2
- Primary Endpoint
- First step: Ability to shoot and supplementary duration of intervention, to use the medical device following requested asepsis procedures and no evidence of hurt on peripheral tissues and to keep vital signs stable
Study Overview
Brief Summary
The purpose of this study is to assess the feasibility, safety and efficacy of High Intensity Focused Ultrasound (HIFU) patients undergoing hepatectomy for colorectal liver metastases. This is a phase I/II study.
Detailed Description
Justification and interest of the study:
Colorectal liver metastases (CLM) are a major public health issue (16 000 deaths each year in France). To date, complete resection of CLM offers the only potential curative approach. However, only a minority of patients (10 to 20%) is candidates. 5-year survival rates after liver resection are ranged from 20 to 35%. Consequently, alternative locally targeted therapies (radiofrequency, cryotherapy, laser, microwave) have been developed and evaluated. Their use presents many limitations: invasive procedures requiring the intraparenchymal introduction of a probe, impossibility of an accurate monitoring in real-time, small size destruction, time-consuming, high recurrence rate. The development of a non-invasive and more accurate technique combined to surgery is required.
High Intensity Focused Ultrasound (HIFU) is a new approach, which enables to generate irreversible cell death through coagulative necrosis in a few seconds. There's no cooling effect of the perfusion because of the shortness of the phenomenon.
The surgical team of the Centre Leon Berard, in collaboration with the INSERM U556 one, has undertaken a research program on CLM treatment by HIFU. A new and very powerful device, without the previously named limitations, has been developed. Preclinical studies have revealed the interest, the feasibility and the safety of this process. These results enable considering preceding the program with an early clinical study.
Experimental design:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years old or more patient,
- •Affected of hepatic metastasis of a colorectal cancer,
- •Who must undergo a hepatectomy by laparotomy with the aim of the resection of hepatic metastasis,
- •ECOG performance status (PS) = 1,
- •Mandatory affiliation to a health security insurance,
- •Written informed consent.
Exclusion Criteria
- •Having already undergone a major hepatic surgery (more than three segments) or biliary major (context of major iterative hepatic surgery),
- •Having already undergone a major abdominal surgery with the exception of a colorectal surgery for the treatment of its primitive tumor (the surgery of the gall-bladder by laparoscopy for the deadline upper to 6 months do not constitute a criterion of not inclusion),
- •Unable to be followed during the duration of the study,
- •Pregnant or breast-feeding woman (a pregnancy test must be negative at the time of the inclusion in the study for the women in age to procreate; a method of reliable contraception must be used during the duration of the study).
Arms & Interventions
Phase I : HIFU
Intervention: HIFU (Procedure)
Phase IIa : HIFU
Intervention: HIFU (Procedure)
Phase IIb : HIFU
Intervention: HIFU (Procedure)
Outcomes
Primary Outcomes
First step: Ability to shoot and supplementary duration of intervention, to use the medical device following requested asepsis procedures and no evidence of hurt on peripheral tissues and to keep vital signs stable
Time Frame: At the end of surgery (realized about 1 week after enrollment)
Phase IIa - First step: accuracy of shootings on a precise area
Time Frame: At the end of surgery (realized about 1 week after enrollment)
both the distance between the hurt epicentre generated by hifu and a mark. These sizes will be measured in mm during anatomopathological exam.
Phase IIb: possibility of ≤ 15 shootings, safety margin ≥ 5 mm in healthy liver.
Time Frame: At the end of surgery (realized about 1 week after enrollment)
Phase IIa - Second step: accuracy of shootings on a zone to be spared
Time Frame: At the end of surgery (realized about 1 week after enrollment)
between the hurt limit and a vessel border previously marked. These sizes will be measured in mm during anatomopathological exam.
Secondary Outcomes
- Phase I: adjust the probe position to different liver segments and patient physical structure.(At the end of surgery (realized about 1 week after enrollment))
- Phase I: Possibility to set a stationary mark, at given depth, echographically detectable(At the end of surgery (realized about 1 week after enrollment))
- Phase I: Possibility to spot echographically a previously Patent Blue or Methylene blue marked vessel(At the end of surgery (realized about 1 week after enrollment))
- Phase I: Mean duration to achieve each step expressed in minutes(initialization, conditioning, targeting, shooting)(At the end of surgery (realized about 1 week after enrollment))
- Phase I: description of outline during perioperative echography(At the end of surgery (realized about 1 week after enrollment))
- Phase I: description of limits during anatomopathological analysis(At the end of surgery (realized about 1 week after enrollment))
- Phase I: distance between the mark / marked vessel and the hurt limits during anatomopathological analysis(At the end of surgery (realized about 1 week after enrollment))
- Phase II: safety of the device(At the end of surgery (realized about 1 week after enrollment))
- Phase II: assessment of vital signs during shooting phase(At the end of surgery (realized about 1 week after enrollment))
- Phase IIa: correlation between hurt perioperative echographic and postoperative macroscopic, measures(At the end of surgery (realized about 1 week after enrollment))