Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan.
Gastroenterological and Transplant Surgery, Graduate School of Biomedical and Health Science, Hiroshima University, Hiroshima, Japan
BMJ Open. 2023 Oct 27;13(10):e075891. doi: 10.1136/bmjopen-2023-075891.
Small liver tumours are difficult to identify during hepatectomy, which prevents curative tumour excision. Preoperative marking is a standard practice for small, deep-seated tumours in other solid organs; however, its effectiveness for liver tumours has not been validated. The objective of this study is to evaluate the effectiveness of preoperative markings for curative resection of small liver tumours.
This is an open-label, single-arm, single-centre, phase II study. Patients with liver tumours of ≤15 mm requiring hepatectomy will be enrolled and will undergo preoperative marking by placing a microcoil near the tumour using either the percutaneous or transvascular approach. The tumours, including the indwelling markers, will be excised. The primary endpoint will be the successful resection rate of liver tumours, defined as achieving a surgical margin of ≥5 mm and ≤15 mm. Secondary endpoints will include the results of preoperative marking and hepatectomy.
Ethical approval for this trial was obtained from the Ethical Committee for Clinical Research of Hiroshima University, Japan. The results will be published at an academic conference or by submitting a paper to a peer-reviewed journal.
jRCTs062220088.
在肝切除术中，小的肝脏肿瘤难以识别，这会妨碍对肿瘤的根治性切除。术前标记是其他实体器官中小而深在的肿瘤的标准做法；然而，其对肝脏肿瘤的有效性尚未得到验证。本研究的目的是评估术前标记对小肝脏肿瘤根治性切除的有效性。
这是一项开放标签、单臂、单中心、二期研究。将招募需要肝切除术的≤15mm 肝脏肿瘤患者，并通过经皮或经血管途径在肿瘤附近放置微线圈进行术前标记。将切除包括留置标记物的肿瘤。主要终点是肝脏肿瘤的成功切除率，定义为达到手术切缘≥5mm 且≤15mm。次要终点将包括术前标记和肝切除术的结果。
本试验已获得日本广岛大学临床研究伦理委员会的伦理批准。结果将在学术会议上发表或通过向同行评议期刊提交论文发表。
jRCTs062220088。
