跳至主要内容
临床试验/NCT03510754
NCT03510754已完成不适用

Endoscopic Ultrasound-guided Biliary Drainage for Malignant Biliary Obstruction After Failed ERCP: a Single Italian Center Experience

Azienda USL Reggio Emilia - IRCCS0 个研究点目标入组 36 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
主要终点
Technical success

研究概览

简要总结

In this study the investigators retrospectively report outcomes of direct transluminal EUS-BD in a series of patients with malignant biliary obstruction after failed ERCP as the experience of a single Italian center

详细描述

INTRODUCTION Endoscopic retrograde cholangiopancreatography (ERCP) with placement of biliary stents is the treatment of choice for palliation of malignant obstructive jaundice and has a success rate of 90% with low morbidity rate.1 In 5 to 10% of cases, even in expert hands, stents' placement failed for several reasons as altered anatomy due to surgical intervention, gastric outlet obstruction, ampullary tumors invasion, high grade biliary strictures and all other causes of failed biliary cannulation.

In these unfortunately cases alternative methods have been developed. Percutaneous transhepatic biliary drainage (PTDB) is a efficacy technique but is associated with an adverse events rate of 30% and a negative impact on the quality of life of patients due to the external drainage;4 furthermore surgical biliodigestive anastomosis is burdened by a morbidity and mortality of 30% and 10% respectively.

An effective alternative to PTDB, introduced for the first time in 1996, is endoscopic ultrasonography-guided biliary drainage (EUS-BD). EUS-BD can be performed by four different routes: EUS-guided hepaticogastrostomy, choledochoduodenostomy, rendezvous and anterograde transpapillary drainage.

Among these, rendezvous technique seems to be the safest of all EUS-guided procedure at the expense of a not excellent success rate (from 44% to 80%) and with the limit of the need of a accessible papilla by endoscopy.8 These limitations are overcome by direct transluminal EUS-guided approach as hepaticogastrostomy and choledochoduodenostomy that also ensure a 1-stage procedure.

In this study the investigators retrospectively report outcomes of direct transluminal EUS-BD in a series of patients with malignant biliary obstruction after failed ERCP as the experience of a single Italian center.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients over 18 years old, malignant bile duct obstruction with unsuccessful ERCP drainage.

排除标准

  • Patients with benign stricture

结局指标

主要结局

Technical success

时间窗: 1 day

the correct placement of the metal or plastic stent across the stomach or duodenum to the chosen biliary branch, with radiologically and endoscopically confirmed.

Early clinical success

时间窗: 14 days

drop of bilirubin hematic level by 50 % after 2 week from EUS-BD

late clinical success

时间窗: 30 days

as the reaching of hematic bilirubin level compatible with a possible chemotherapy treatment at 3-4 weeks after the endoscopic performance

次要结局

  • Procedure-related adverse events(30 days)
  • Stent patency(1 year)
  • Re-stenting(1 year)

研究者

发起方
Azienda USL Reggio Emilia - IRCCS
申办方类型
Other Gov
责任方
Sponsor

相似试验

Endoscopic Ultrasound-guided Biliary Drainage for... | 临床试验