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临床试验/NCT05786326
NCT05786326已完成不适用

The Use of Multi Holes Fully Covered Metallic Stents Versus Uncovered and Partially Covered Metallic Stents in the Management of Malignant Biliary Obstruction: Randomized Parallel Clinical Trial.

Zagazig University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年3月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Efficacy of multi holes fully covered metallic stents in management of malignant biliary obstruction

研究概览

简要总结

multiholes fully covered metallic stents in the management of malignant biliary obstruction

详细描述

Malignant biliary obstruction is still a diagnostic and therapeutic challenge requiring a multidisciplinary approach. Most cases are inoperable at the time of diagnosis. Relieving the obstruction and normalizing the serum bilirubin level is usually the first step by biliary catheterization and stent placement.

Biliary stent placement has largely replaced surgical bypass for the palliation of malignant biliary obstruction. Rigid plastic stents, despite it is cheap and easily removed, but with limited duration of stent patency. Self-expandable metal stents (SEMS) have larger luminal diameters and provide longer patency time than rigid plastic stents. SEMS are composed of a variety of metals and can be uncovered, partially covered, or fully covered.

Uncovered stents are prone to obstruction by tumor growths; however, covered stents may block bile duct branches and are at risk of migration. A multihole self-expandable metallic stent was developed to prevent the obstruction of bile duct branches. In addition, the holes may prevent migration due to small ingrowths which reduce the tension of the membrane

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

  • •Clinical diagnosis of malignant obstructive jaundice.
  • •Patient not eligible for surgery.
  • •Age above 18 years, any gender.

排除标准

  • •Benign obstructive jaundice.
  • •Patient eligible for surgery.
  • •Failure to stent insertion.
  • •Patient not fit for ERCP and/or anaesthesia.
  • •Surgical and anatomical abnormalities interfere with endoscopy.

研究组 & 干预措施

multiholes fully covered metaalic stents group

Experimental

Insertion of multiholes fully covered self-expandable metallic stents in the biliary tree through Endoscopic retrogrades cholangiopancreatography (ERCP)patients with malignant biliary obstruction.

干预措施: group 1 (Device)

parially covered metallic stents group

Active Comparator

Insertion of partially covered metallic stents in patients with malignant biliary obstruction.

干预措施: group 2 (Device)

unocoered metaalic stents group

Active Comparator

Insertion of uncovered metallic stents in patients with malignant biliary obstruction.

干预措施: group 3 (Device)

结局指标

主要结局

Efficacy of multi holes fully covered metallic stents in management of malignant biliary obstruction

时间窗: at 3 and 6 months follow up after stents ineration

Detect the stent in his place. Patients clinically improved, and bilirubin decrease or reach normal values.

次要结局

  • Stent dysfunction (obstruction or migration)(after 3 and 6 months from stents insertion)

研究者

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

H Abdelkader

lecturer at tropical medicine department, faculty of medicine,Zagazig

Zagazig University

研究点 (1)

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