NCT04717687撤回不适用
Étude Pilote de l'évaluation de la Technique de l'électroporation irréversible Dans le Cholangiocarcinome Infiltrant périhilaire
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- The success rate of the technique, being the realisation of the irreversible electroporation.
研究概览
简要总结
The aim of the study is to evaluate the feasibility of irreversible electroporation in the treatment of locally advanced cholangiocarcinoma. This technique would allow to treat the unresectable part of the tumor to make it more accessible for a secondary surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old
- •Patient with infiltrating cholangiocarcinoma of the gallstone convergence considered as unresectable on the pre-operative imaging data performed during the month preceding inclusion, and in multidisciplinary consultation meeting specialised in digestive oncology
- •Histologically (or cytologically) proven tumor of less than 4 cm of the largest diameter
- •World Health Organization Performance Index 0 or 1
- •No history of other cancer, except baso-cellular skin carcinoma or epidermoid cervix cancer or any other cancer in complete remission for more than 3 years
- •No prior radiotherapy for cholangiocarcinoma
- •Biological analyses performed during the month preceding inclusion : hepatic enzymes (AST and ALT <3N), preserved renal function (creatinine clearance according to Modification of the Diet in Renal Disease >50ml/min); bilirubin <3N; bile drainage must be correct with a bilirubin below 3N , with or without drainage/prothesis, hemoglobin >9g/dL, leucocytes >3500/mm3, platelets >75000/mm3, prothrombin rate >70%
- •Signature of the informed consent
排除标准
- •Cholangiocarcinoma of more than 4cm diameter or resectable according tio the imaging data
- •Severe and/or uncontrolled (cardiac, pulmonary, renal, liver decompensation...) visceral failure, in the 6 months preceding the study
- •Visceral metastases or peritoneal carcinosis
- •History of cancers except if remission for more than 3 years, in-situ cancer, epidermoid or baso-cellular cancer
- •Metal biliary prothesis non extractable
- •Patient with history of epileptic events
- •History of myocard infarction for less than 6 months
- •Unstabilised coronary disease for at least 6 months
- •Cardiac rhythm trouble or QT space above 550ms without treatment
- •Patient eligible to liver transplant
- •Patient naive of chemiotherapy
- •Patient with a pacemaker, an implanted automatic defibrillator or an automatic electronic device or an electronic device with metal pieces
- •Patient with contra-indication to the use of NanoKnife system
- •History of hypersensitivity to gadolinium or to iodized contrast product not allowing a suitable radiologic monitoring
- •Refusal or language or psychic incapacity to sign the informed consent
- •Subject who cannot submit to the constraints of the protocol (subjects for which an MRI or a scan is contra-indicated, claustrophobic subjects, non cooperative or not able to come to the follow-up visits)
- •Concomitant participation to another study
- •Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.
- •Women at age to procreate and not using effective contraception
结局指标
主要结局
The success rate of the technique, being the realisation of the irreversible electroporation.
时间窗: At Day 0
The study will be considered positive if the success rate is above 90% and the complication rate below or equal to 30%
次要结局
未报告次要终点
研究者
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