NCT05595122招募中不适用
EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction: a Pilot Study Using FCSEMS Through LAMS
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年12月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Stentdysfunction after technical successful EUS-CDS
研究概览
简要总结
A prospective single-centre pilot study investigating the feasibility and safety of EUS-guided choledochostomy as primary drainage strategy in patients with distal malignant biliary obstruction using a FCSEMS through LAMS to reduce stent dysfunction.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Written informed consent
排除标准
- •Age < 18 year
- •Surgically altered anatomy after previous gastric, periampullary or duodenal resection
- •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.
结局指标
主要结局
Stentdysfunction after technical successful EUS-CDS
时间窗: 6 months
Recurrent jaundice after initial clinical success, ongoing jaundice in combination with remaining dilatation of the bile ducts, or cholangitis.
次要结局
- Time to stent dysfunction(6 months)
- Number of participants with technical success of LAMS placement(1 day (directly after intervention))
- Number of participants with technical success of FCSEMS through LAMS(1 day (directly after intervention))
- Number of participants with clinical success(14 days)
- Procedure time(1 day (directly after intervention))
- Adverse events(6 months)
- Number of re-interventions(6 months)
- Time to start treatment (chemotherapy or surgery)(6 months)
- Hospitalization(30 days)
- Survival(6 months)
- Costs(6 months)
研究者
Rogier P. Voermans
Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (2)
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