两种不同切除技术（传统肝切除与前入路）对结直肠癌肝转移血行肿瘤细胞播散的影响——前瞻性随机多中心试验
Influence of two different resection techniques (conventional liver resection versus anterior approach) of liver metastases from colorectal cancer on hematogenous tumor cell dissemination - prospective randomized multicenter trial.
作者信息
Schmidt T, Koch M, Antolovic D, Reissfelder C, Schmitz-Winnenthal F H, Rahbari N N, Schmidt J, Seiler C M, Büchler M W, Weitz J
机构信息
Department of Surgery, University of Heidelberg, Heidelberg, Germany.
出版信息
BMC Surg. 2008 Mar 5;8:6. doi: 10.1186/1471-2482-8-6.
BACKGROUND
Surgical hepatic resection remains the treatment of choice for patients with liver metastases from colorectal cancer despite the use of alternative therapeutic strategies. Although this procedure provides long-term survival in a significant number of patients, 50-75% of the patients develop intra- and/or extrahepatic recurrence. One possible reason for tumor recurrence may be intraoperative hematogenous tumor cell dissemination due to mechanical manipulation of the tumor during hepatic resection. Surgical technique may have an influence on hematogenous tumor cell spread. We hypothesize that hematogenous tumor cell dissemination may be reduced by using the anterior approach technique compared to conventional liver resection.
METHODS/DESIGN: This is a multi-centre prospective randomized controlled, superiority trial to compare two liver resection techniques of liver metastases from colorectal cancer. 150 patients will be included and randomized intraoperatively after surgical exploration just prior to resection. The primary objective is to compare the anterior approach with the conventional liver resection technique with regard to intraoperative haematogenous tumor cell dissemination. As secondary objectives we examine five year survival rates (OS and DFS), blood loss, duration of operation, requirement of blood transfusions, morbidity rate, prognostic relevance of tumor cell detection in blood and bone marrow and the comparison of tumor cell detection by different detection methods.
CONCLUSION
This trial will answer the question whether there is an advantage for the anterior approach technique compared to the conventional resection group with regard to tumor cell dissemination. It will also add further information about prognostic differences, safety, advantages and disadvantages of each technique.
TRIAL REGISTRATION
Current controlled trials - ISRCTN45066244.
背景
尽管采用了其他治疗策略，但手术肝切除仍是结直肠癌肝转移患者的首选治疗方法。虽然该手术能使大量患者获得长期生存，但仍有50% - 75%的患者会发生肝内和/或肝外复发。肿瘤复发的一个可能原因可能是肝切除术中对肿瘤的机械操作导致肿瘤细胞经血行播散。手术技术可能会影响肿瘤细胞的血行播散。我们假设与传统肝切除相比，采用前入路技术可减少肿瘤细胞的血行播散。
方法/设计：这是一项多中心前瞻性随机对照优势试验，旨在比较两种结直肠癌肝转移的肝切除技术。将纳入150例患者，在手术探查后、切除术前进行术中随机分组。主要目的是比较前入路与传统肝切除技术在术中肿瘤细胞血行播散方面的差异。次要目的包括检查五年生存率（总生存期和无病生存期）、失血量、手术时间、输血需求、发病率、血液和骨髓中肿瘤细胞检测的预后相关性以及不同检测方法对肿瘤细胞检测的比较。
结论
该试验将回答与传统切除组相比，前入路技术在肿瘤细胞播散方面是否具有优势的问题。它还将提供有关每种技术的预后差异、安全性、优缺点的更多信息。
试验注册
当前受控试验 - ISRCTN45066244
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