NL-OMON53481招募中不适用
EUS-guided choledochoduodenostomy for primary drainage of malignant distal biliary obstruction: a pilot study using FCSEMS through LAMS - SCORPION-II-pilot study
Amsterdam UMC0 个研究点目标入组 25 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Radiographically (CT or EUS) distal malignant bile duct obstruction
- •- Histology or cytology proven malignancy of the primary tumour or metastasis;
- •onsite cytology evaluation after EUS guided fine-needle sampling that is highly
- •suspected of a malignancy suffices
- •- Indication for biliary drainage; in case of a resectable tumour this should
- •be discussed during a clinical multidisciplinary meeting
排除标准
- •- Age < 18 year
- •- Surgically altered anatomy after previous gastric, periampullary or duodenal
- •- Cancer extending into the antrum or proximal duodenum
- •- Extensive liver metastases
- •- WHO performance score of 4 (in bed 100% of time)
- •- Uncorrectable coagulopathy, defined by INR>1.5 or platelets < 50 x 10^9/L*
- •- Clinically relevant gastric-outlet obstruction
- •- Unable to complete sign informed consent
- •* Inclusion is allowed after corrective treatment measures are taken, according
- •to local protocol and treating physician.
研究者
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