Back to resultsUnravelling the Impact of Radiofrecuency in Liver Surgery: the Key to Decrease Local Recurrence? (LIVERaTION)
Primary Purpose
Liver Cancer, Cancer, Treatment-Related
Status
Not yet recruiting
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Additional margin coagulation
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cancer
Eligibility Criteria
Inclusion Criteria:
- Written informed consent granted prior to the initiation of the surgical procedure, given with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
- 18 year of age or older
- WHO performance scale 0-2 (see appendix 1)
- Patients suffering from liver metastases of colorectal origin confirmed either by abdominal CT, abdominal MRI or/and by histologic-cytological evaluation.
- Patients suffering from primary liver tumor such as Hepatocarcinoma
- Patients suffering from other extra-liver metastases when they are assumed to be curable at any moment are allowed to join the trial (e.g. lung metastases that are amenable to be resected at any moment).
- Patients should not have been previously treated by either local therapy or resection in the liver (naïve for local or resection approach of the liver).
- Any previous chemotherapy regime is permitted.
- ASA (American Society of Anesthesiology classification) of the patient: 1 to 3
Exclusion Criteria:
- Previous or concurrent cancer that is distinct from one primary tumor of which the LM come from EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to enrollment is permitted.
- ASA 4
- Non-resectable extrahepatic metastases
- Liver metastasis from other origin apart from colorectal
- Any condition that in the opinion of the investigator may interfere evaluation of the study results.
Sites / Locations
- Hospital del Mar Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Arm 1: Control
Arm 2: study arm
Arm Description
In this arm it will be permitted one/several conventional methods according to surgeon preference: Conventional crusch-clamp or finger fracture technique Ultrasonic dissector (CUSA, SONOK..) or Ultrasonic mediated devices Water jet dissector Argon beam coagulator
In this arm it will be permitted to use the radiofrequency devices which have demonstrated evidence in the literature in terms of reducing local recurrence alone or in combination with any conventional method described previously in Arm. (Coolingbis device by VecMedical as well as Aquamantys (Medtronic) These devices and their operating procedure have been described in detail elsewhere Briefly, it consists of a handheld instrument that might be employed not only for margin coagulation but also as hemostatic instrument. After performing the hepatectomy the bladeless part of the device should be applied onto the surgical margin following the protocol 3-4 s/cm2 of liver transection surface at maximum power output.in order to perform an additional margin coagulation
Outcomes
Primary Outcome Measures
Local recurrence
Local recurrence (LR): defined as any growing or enhancing tumour in the margin of hepatic resection specifically reviewed to this aim in a later follow-up imaging
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05492136
Brief Title
Unravelling the Impact of Radiofrecuency in Liver Surgery: the Key to Decrease Local Recurrence?
Acronym
LIVERaTION
Official Title
Unravelling the Impact of Radiofrecuency in Liver Surgery: the Key to Decrease Local Recurrence? (Study LIVERaTION)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital del Mar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Radiofrequency devices have been increasingly employed in liver surgery in order to achieve proper hemostasis and this use has become more evident with the implementation of minimal invasive surgery. Due to its well-known efficacy for tumor ablation (i.e. hepatocarcinoma) it use has been extended in some cases to ablate the liver surface after resection in questionable resection. Till date, despite the majority of surgeons apply an additional coagulation in doubtful margins, there is not an evidence that this maneuver really decreases the local recurrence or increases the overall survival. On the contrary, some studies have suggested that non-anatomical resections in order to spare liver parenchyma could lead to major zones of liver ischemia in the remnant liver and thus favoring recurrence. However, major liver ischemia (defined as grade 2 o more) is unlikely to be provoked by 1 cm-depth additional coagulation of the margin.
The investigators previously published in a retrospective study the concept of additional margin coagulation within liver resections and narrow margins and demonstrated that the study group had significantly less local recurrence compared to the controls. Therefore, in the present study the aim is to continue this evaluation through a multicenter randomized clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Cancer, Treatment-Related
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1566 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Control
Arm Type
No Intervention
Arm Description
In this arm it will be permitted one/several conventional methods according to surgeon preference:
Conventional crusch-clamp or finger fracture technique
Ultrasonic dissector (CUSA, SONOK..) or Ultrasonic mediated devices
Water jet dissector
Argon beam coagulator
Arm Title
Arm 2: study arm
Arm Type
Experimental
Arm Description
In this arm it will be permitted to use the radiofrequency devices which have demonstrated evidence in the literature in terms of reducing local recurrence alone or in combination with any conventional method described previously in Arm. (Coolingbis device by VecMedical as well as Aquamantys (Medtronic) These devices and their operating procedure have been described in detail elsewhere Briefly, it consists of a handheld instrument that might be employed not only for margin coagulation but also as hemostatic instrument. After performing the hepatectomy the bladeless part of the device should be applied onto the surgical margin following the protocol 3-4 s/cm2 of liver transection surface at maximum power output.in order to perform an additional margin coagulation
Intervention Type
Procedure
Intervention Name(s)
Additional margin coagulation
Intervention Description
After performing the hepatectomy the selected device should be applied onto the surgical margin following the protocol 3-4 s/cm2 of liver transection surface at maximum power output in order to perform an additional margin coagulation
Primary Outcome Measure Information:
Title
Local recurrence
Description
Local recurrence (LR): defined as any growing or enhancing tumour in the margin of hepatic resection specifically reviewed to this aim in a later follow-up imaging
Time Frame
5 years follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent granted prior to the initiation of the surgical procedure, given with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
18 year of age or older
WHO performance scale 0-2 (see appendix 1)
Patients suffering from liver metastases of colorectal origin confirmed either by abdominal CT, abdominal MRI or/and by histologic-cytological evaluation.
Patients suffering from primary liver tumor such as Hepatocarcinoma
Patients suffering from other extra-liver metastases when they are assumed to be curable at any moment are allowed to join the trial (e.g. lung metastases that are amenable to be resected at any moment).
Patients should not have been previously treated by either local therapy or resection in the liver (naïve for local or resection approach of the liver).
Any previous chemotherapy regime is permitted.
ASA (American Society of Anesthesiology classification) of the patient: 1 to 3
Exclusion Criteria:
Previous or concurrent cancer that is distinct from one primary tumor of which the LM come from EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis & T1). Any cancer curatively treated > 3 years prior to enrollment is permitted.
ASA 4
Non-resectable extrahepatic metastases
Liver metastasis from other origin apart from colorectal
Any condition that in the opinion of the investigator may interfere evaluation of the study results.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos fuste, MD PhD
Phone
0034 932483207
Email
cfuste@imim.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Sánchez Velazquez, MD PhD FEBS
Organizational Affiliation
Hospital del Mar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital del Mar Research Institute
City
Barcelona
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Unravelling the Impact of Radiofrecuency in Liver Surgery: the Key to Decrease Local Recurrence?
We'll reach out to this number within 24 hrs