跳至主要内容
临床试验/NCT04915703
NCT04915703招募中不适用

Flushing of Internalized Percutaneous Transhepatic Biliary Drainage Catheters

Erasmus Medical Center1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2022年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
38
试验地点
1
主要终点
time-to-symptom-onset in patients with an internal external PTBD catheter without daily flushing compared to patients with an internal external PTBD catheter who daily flush the catheter

研究概览

简要总结

Percutaneous transhepatic biliary drainage (PTBD) is a drainage method for biliary obstruction. Patients with a PTBD catheter often need multiple re-interventions because of symptoms of catheter obstruction such as pain, jaundice, pruritus, leakage and/or fever. The onset of these symptoms results in hospital visits, opening of the external catheter of an internal external PTBD and re-interventions.

The investigators hypothesize that daily flushing of an internal external biliary catheter will increase the time-to-symptom-onset.

详细描述

Bile is synthesized and secreted by the liver and transported into the peripheral bile ducts, to the left or right hepatic duct which join together in the common hepatic duct and more distally in the common bile duct. Secreted bile is stored in the gall bladder. During a meal, the bile is secreted into the duodenum.

Obstruction of the biliary tract will result in cholestasis with symptoms as jaundice and pruritus and cholangitis in case of infection, usually related to prior biliary intervention. Causes of biliary obstruction are benign or malignant.

Percutaneous transhepatic biliary drainage (PTBD) is a drainage method for biliary obstruction. The procedure starts with percutaneous puncture under fluoroscopic or ultrasound guidance and cannulation of the peripheral biliary tree, which is confirmed by contrast injection in the biliary tree. The needle will be exchanged for a guidewire which can be advanced into the biliary tract. When the correct position is reached, a drainage catheter with side holes is placed.

There are two types of PTBD techniques: placement of an external biliary drain and placement of an internal external biliary drain. The external biliary drain is positioned in the bile duct above a stenosis and drains the bile externally into a bag outside the patient. Capping of an external biliary drain will stop the drainage of bile into the bag and forces the bile to drain towards the digestive tract. The internal external biliary drain is placed in the bile duct and the tip of the internal external biliary drain is localised in the duodenum allowing both bile flow through the drain to the digestive tract (internal) or into the bag (external). Capping of an internal external biliary drain will stop the external drainage and results in internal drainage only.

Complications of PTBD are bleeding (usually during or shortly after the procedure), infection (cholangitis, abscess, peritonitis, cholecystitis, pancreatitis), catheter obstruction and catheter dislocation(1). Catheter obstruction will result in cholestasis resulting in jaundice, drain leakage and finally cholangitis. The exact prevalence of PTBD catheter obstruction is not described in literature, however the prevalence of cholangitis in patients with a PTBD catheter is reported as high as 59%(2). Subsequently, the PTBD catheter often needs a revision (re-intervention), i.e. exchanging the catheter for a new one. If catheter obstruction is assessed during re-intervention, attempts can be made to remove the obstruction or the obstructed PTBD catheter can be exchanged for a new PTBD catheter.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

盲法说明

open

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

  • •Patient with obstruction of the bile duct(s) planned for internal external PTBD;
  • •Proficient in Dutch language;
  • •Written informed consent.

排除标准

  • •Age < 18 years;
  • •No informed consent;
  • •Pregnancy;
  • •Obstruction caused by gall stones;
  • •External PTBD catheter (without internalization);
  • •Patient has already a PTBD catheter;
  • •More than 1 PTBD catheter is placed at intervention.

研究组 & 干预措施

Intervention

Experimental

flushing of internal external PTBD catheter 3 times a day

干预措施: Flushing of PTBD catheter (Procedure)

Standard of Care

No Intervention

no flushing of PTBD catheter

结局指标

主要结局

time-to-symptom-onset in patients with an internal external PTBD catheter without daily flushing compared to patients with an internal external PTBD catheter who daily flush the catheter

时间窗: 12 weeks

time-to-symptom-onset

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adriaan Moelker

Radiologist

Erasmus Medical Center

研究点 (1)

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