Clinical trial · Interventional
Study to Evaluate a High Intensity Focused Ultrasound (HIFU) Procedure in Patient With Liver Metastases
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.
NCT01489787CI-TRIAL-00031421HIFUunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HIFU | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase I : HIFU
- interventionNames
- Procedure: HIFU
- type
- EXPERIMENTAL
- label
- Phase IIa : HIFU
- interventionNames
- Procedure: HIFU
- type
- EXPERIMENTAL
- label
- Phase IIb : HIFU
- interventionNames
- Procedure: HIFU
Primary outcomes (4)
- measure
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (28)
- BACKGROUNDManfredi S, Lepage C, Hatem C, Coatmeur O, Faivre J, Bouvier AM. Epidemiology and management of liver metastases from colorectal cancer. Ann Surg. 2006 Aug;244(2):254-9. doi: 10.1097/01.sla.0000217629.94941.cf. PMID 16858188
- BACKGROUNDBismuth H, Adam R, Levi F, Farabos C, Waechter F, Castaing D, Majno P, Engerran L. Resection of nonresectable liver metastases from colorectal cancer after neoadjuvant chemotherapy. Ann Surg. 1996 Oct;224(4):509-20; discussion 520-2. doi: 10.1097/00000658-199610000-00009. PMID 8857855
- BACKGROUNDMulier S, Ni Y, Jamart J, Ruers T, Marchal G, Michel L. Local recurrence after hepatic radiofrequency coagulation: multivariate meta-analysis and review of contributing factors. Ann Surg. 2005 Aug;242(2):158-71. doi: 10.1097/01.sla.0000171032.99149.fe. PMID 16041205
- BACKGROUNDRivoire M, De Cian F, Meeus P, Negrier S, Sebban H, Kaemmerlen P. Combination of neoadjuvant chemotherapy with cryotherapy and surgical resection for the treatment of unresectable liver metastases from colorectal carcinoma. Cancer. 2002 Dec 1;95(11):2283-92. doi: 10.1002/cncr.10973. PMID 12436433
- BACKGROUNDAntoniou A, Lovegrove RE, Tilney HS, Heriot AG, John TG, Rees M, Tekkis PP, Welsh FK. Meta-analysis of clinical outcome after first and second liver resection for colorectal metastases. Surgery. 2007 Jan;141(1):9-18. doi: 10.1016/j.surg.2006.07.045. Epub 2006 Nov 17. PMID 17188163
- BACKGROUNDPawlik TM, Schulick RD, Choti MA. Expanding criteria for resectability of colorectal liver metastases. Oncologist. 2008 Jan;13(1):51-64. doi: 10.1634/theoncologist.2007-0142. PMID 18245012
- BACKGROUNDGarcea G, Lloyd TD, Aylott C, Maddern G, Berry DP. The emergent role of focal liver ablation techniques in the treatment of primary and secondary liver tumours. Eur J Cancer. 2003 Oct;39(15):2150-64. doi: 10.1016/s0959-8049(03)00553-7.