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Cholangiocarcinoma treatment with radiofrequency ablation or photodynamic therapy (CARP)

Cholangiocarcinoma treatment with radiofrequency ablation or photodynamic therapy (CARP)
射频消融或光动力疗法 (CARP) 治疗胆管癌
批准号:
434336116
负责人:
Professor Dr. Albrecht Hoffmeister
金额:
$0.0万
依托单位国家:
德国
项目类别:
Clinical Trials
财政年份:
--
资助国家:
德国
项目状态:
未结题
起止时间:

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中文摘要
翻译
Klatkin肿瘤是胆道癌的一种形式。它们通常直到很晚才被诊断出来,而且很少有可能进行根治性手术。它们的解剖位置通常会导致胆管梗阻,因此治疗的目的是保持胆管的开放。这是通过植入支架的内窥镜逆行胆胰管造影术(ERCP)完成的。支架疗法结合光动力疗法(PDT)可延长预期寿命。光动力疗法需要注射主要被癌细胞吸收的光敏剂。然后用ERCP对特定波长的光进行照射,以杀死癌细胞。缺点不仅包括高成本和可获得性差,而且最重要的是,患者必须在几周内避免阳光直射。射频消融(RFA)和支架植入构成了一种替代方法,在ERCP过程中通过加热杀死癌细胞。RFA技术可用范围更广,部署也更容易。然而,它还没有得到广泛的研究。目前还没有比较这两种方法的随机试验。目前申请中描述的这项试验将根据接受PDT还是RFA来比较Klatkin肿瘤患者的存活率。此外,还将收集有关副作用和生活质量的数据。
英文摘要
Klatskin tumours are a form of bile duct cancer. They are generally not diagnosed until quite late and a curative operation is rarely a possibility. Their anatomic location usually results in bile duct obstruction and the aim of therapy is thus to keep the ducts open. This is accomplished through endoscopic retrograde cholangiopancreatography (ERCP) by implanting stents. Stent therapy combined with photodynamic therapy (PDT) extends life expectancy. PDT requires an injection of photosensitizer that is absorbed primarily by the cancer cells. Light of a particular wavelength is then applied with ERCP to kill the cancer cells. Drawbacks include not only high costs and poor availability, but foremost that patients have to avoid direct sunlight for a period of weeks. Radio frequency ablation (RFA) together with stent implantation constitutes an alternative by which the cancer cells are killed through heat applied during ERCP. The RFA technology is more widely available and easier to deploy. However, it has not been studied extensively. No randomized trials exist comparing the two methods. The trial described in the current application will compare survival in patients with Klatskin tumours depending on whether they receive PDT or RFA. Moreover, data will be collected on side-effects and quality of life.
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A multi-centred, randomized, controlled trial comparing weight loss in endoscopically implanted duodenal-jejunal bypass liner vs intragastric balloons vs a sham procedure
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