DRKS00013276招募中2 期
Microscopic Tumor Clearance after Liver Transplantation for Proximal Bile Duct Cancer - pro-duct002
Charité - Universitätsmedizin Berlin, Chirurgische Klinik, Campus Charité Mitte | Charité Campus Virchow-Klinikum0 个研究点目标入组 50 人开始时间: 2018年1月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Protocol defined diagnosis of perihilarcholangiocarcinoma in patients with primary sclerosing cholangitis (PSC): i.e. histological diagnosis of cholangiocarcinoma (obtained via ERC) or dominant stenosis plus cytological diagnosis of severe dysplasia or two subsequent cytological results of severe dysplasia or carcinoma whereby the second has been obtained after 2 weeks of antibiotic treatment to exclude inflammatory changes
- •Protocol defined diagnosis of perihilar cholangiocarcinoma in patients without PSC: clinical diagnosis of proximal bile duct cancer based on ERC plus a second method (CT or MRI), cytology is obtained during ERC, but a cytological result of carcinoma or severe dysplasia is not mandatory
- •tumor not curatively resectable as judged by an experienced hepatobiliary surgeon (> 50 liver resections for perihilar cholangiocarcinoma)
- •on-line review of defined patient data and acceptance for priority listing by an Eurotransplant expert panel consisting of two experts recruited from the Eurotransplant Liver Allocation Committee; in case of split decision addition of a third expert for definite decision on priority listing with a respective matchMELD.
- •obligatory diagnostic laparoscopy (including robotic approach) or laparotomy before priority listing (see SOP diagnostic laparoscopy (including robotic approach)/laparotomy, chapter, chapter 7.5.1.4)
- •age between 18 and 70 years
- •negative pregnancy test
- •informed consent before study enrolment (all other procedures are clinical routine procedures in the management of these patients)
排除标准
- •locally very advanced, unresectable tumor infiltrating adjacent other organs, the main trunk of the hepatic artery
- •a visible tumor mass on CT or MRI scan larger than 3 cm in diameter
- •highly elevated CA 19-9 levels (> 1000 U/ml)
- •Decompression of the bile ducts by external drainage (PTCD)
- •tumors suspicious for gallbladder cancer
- •known lymph node or distant metastasis (determined mandatory by CT scan/MRI and diagnostic laparoscopy (including robotic approach) or laparotomy, further investigations if deemed necessary, a PET scan is recommended)
- •patients undergoing multi-organ transplantation or have undergone previous solid organ or bone marrow transplantation
- •previous photodynamic therapy, radiation, brachytherapy or combinations of these procedures
- •previous tumor biopsy (except via ERC) systematic lymphadenectomy (except SOP defined diagnostic laparoscopy (including robotic approach/laparotomy), surgical preparation at the region of the hepatoduodenal ligament (except cholecystectomy for other reasons) or previous completed or attempted surgery for hilar cholangiocarcinoma
- •pregnancy or breastfeeding
- •patients unwilling to consent to saving and propagation of pseudonymized medical data for study reasons
- •general contraindications for liver transplantation
- •subjects who are legally detained in an official institute
研究者
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