Unravelling the Impact of Radiofrecuency in Liver Surgery: the Key to Decrease Local Recurrence?

Официальное название

Unravelling the Impact of Radiofrecuency in Liver Surgery: the Key to Decrease Local Recurrence? (Study LIVERaTION)

Обзор

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.

Вмешательства

• Процедура Additional margin coagulation
  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

Первичные конечные точки

• Local recurrence [Срок оценки: 5 years follow-up]

Вторичные конечные точки (5)

• overall survival (OS) [Срок оценки: From the surgery to death or lost of follow-up whichever came first, assessed up to 24 months]
• Disease free survival (DFS) [Срок оценки: 2 years of follow-up]
• Cancer specific survival (CSS) [Срок оценки: From the surgery to recurrence/last follow-up whichever came first, assessed up to 24 months]
• Postoperative complications [Срок оценки: 90 days after surgery]
• Hepatic recurrence [Срок оценки: From the surgery to hepatic recurrence or lost of follow-up whichever came first, assessed up to 24 months]

Критерии участия

Критерии включения

• 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
• Consecutive patients (both sexes equally distributed) suffering from CRLM confirmed either by abdominal CT, abdominal MRI or/and by histologic-cytological evaluation or patients suffering from HCC.
• Any previous chemotherapy regime is permitted.
• ASA score 1 to 3.

Критерии исключения

• Previous or concurrent cancer that is distinct from one primary tumor of which the Liver metastasis comes 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.
• Bening primary tumor of the liver.
• Pregnant woman.
• Participation in another clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Hospital del Mar Research Institute — Barcelona

Публикации

• 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, Orreg PMID 41290310

Идентификаторы

NCT: NCT05492136 · Liveration_v2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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