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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Control | No Intervention | In this arm it will be permitted one/several conventional methods according to surgeon preference:
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| Arm 2: study arm | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Additional margin coagulation | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival (OS) | defined as time from surgery until death or the end of the study, patients who discontinue from the study without disease will be censored at the time of their last tumour evaluation prior to death or discontinuation. | From the surgery to death or lost of follow-up whichever came first, assessed up to 24 months |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos fuste, MD PhD | Contact | 0034 932483207 | cfuste@imim.es |
| Name | Affiliation | Role |
|---|---|---|
| Patricia Sánchez Velazquez, MD PhD FEBS | Hospital del Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Mar Research Institute | Recruiting | Barcelona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41290310 | Derived | Luque Villalobos E, Ielpo B, Aldrighetti L, Anselmo A, Beghdadi N, Berardi G, Briceno F, Ciria R, Dorcaratto D, Durczynski A, Ettorre GM, Delvecchio A, Ferri V, Grat M, Garces-Albir M, Grochola LF, Hogendorf P, Izzo F, Kobryn K, Kontis E, Korkolis D, Krol R, Lesurtel M, Lopez-Ben S, Christogiannis C, Koutsiouroumpa O, Mavridis D, Memeo R, Murawa D, Machairas N, Mora-Oliver I, Munoz-Forner E, Orrego C, Dantas C, Fuste C, Garcia Picazo A, Pessaux P, Pilat T, Pittau G, Radosevic A, Ratti F, Sotiropoulos G, Toutouzas K, Trotovsek B, Wystrychowski W, Zacharoulis D, Vicente E, Burdio F, Sanchez Velazquez P. LIVERATION trial: a multicentre European randomised study on radiofrequency margin coagulation and its impact on oncological outcomes after liver surgery - study protocol. BMJ Open. 2025 Nov 24;15(11):e100518. doi: 10.1136/bmjopen-2025-100518. |
| Label | URL |
|---|---|
| Website | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 30, 2024 | Sep 1, 2025 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D016609 | Neoplasms, Second Primary |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| Disease free survival (DFS) |
Disease free survival (DFS), calculated as the time from surgery until disease progression, patients who have not progressed at the time the SVR analysis is performed will be censored at the time of their last tumour evaluation |
| 2 years of follow-up |
| Cancer specific survival (CSS) | Cancer-specific survival (CSS), measured from the date of surgery to the date of death from colorectal cancer/HCC or last follow-up. | From the surgery to recurrence/last follow-up whichever came first, assessed up to 24 months |
| Postoperative complications | Graded by Clavien-Dindo clasification and CCI | 90 days after surgery |
| Hepatic recurrence | Tumoral recurrence within the liver | From the surgery to hepatic recurrence or lost of follow-up whichever came first, assessed up to 24 months |
| D008107 |
| Liver Diseases |