跳至主要内容
临床试验/NCT07096895
NCT07096895招募中不适用

EUS-directed Transenteric ERCP (EDEE) in Patients With Benign and Malignant Underlying Conditions and Inaccessible Papilla/Biliodigestive Anastomosis (BDA)

Evangelisches Krankenhaus Düsseldorf1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年2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
40
试验地点
1
主要终点
Technical success rate

研究概览

简要总结

Safety and efficacy of EDEE (EUS-directed transenteric ERCP)

详细描述

Background and Study Objective Endoscopic retrograde cholangiopancreatography (ERCP) is considered the gold standard when biliary intervention is indicated. However, there are situations where conventional ERCP is no longer feasible - for example, in the presence of malignant gastric outlet obstruction.

Additionally, the number of patients with surgically altered anatomy due to benign or malignant underlying diseases is increasing. For this group of patients, enteroscopy-assisted ERCP can generally be considered. However, the success rate of this procedure varies depending on the anatomical situation and is only around 61.7%. Therefore, patients in whom the papilla or the biliodigestive anastomosis (BDA) cannot be reached either via conventional endoscopy or enteroscopy-assisted ERCP - yet require biliary intervention - present a particular clinical challenge.

Traditionally, the only option in such cases has often been percutaneous transhepatic drainage (PTBD). This approach frequently requires repeated procedures over several months and, in some cases, results in a permanent external drainage. In recent years, endoscopic ultrasound (EUS)-guided techniques have emerged as a promising treatment option for this patient population. These methods show a high technical success rate of approximately 90%, but are not suitable in cases requiring complex interventions (e.g., multiple strictures of the BDA) or when targeting the right biliary system.

An alternative approach involves a two-step procedure: first, an EUS-guided entero-enteric anastomosis is created using a lumen-apposing metal stent (LAMS); in a second step, ERCP is performed via the LAMS. This procedure is referred to in the literature as Endoscopic Ultrasound-Directed Transenteric ERCP (EDEE).

Since only a few systematic studies on this alternative procedure have been published so far, the objective of this retrospective study is to assess the technical and clinical success rates and evaluate the safety of EDEE.

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

  • •signed consent form
  • •Indication for an EDEE
  • •Age >18 years

排除标准

  • •Age < 18 years

研究组 & 干预措施

EDEE

Experimental

干预措施: EDEE (EUS-directed transenteric ERCP) (Procedure)

结局指标

主要结局

Technical success rate

时间窗: during the procedure

number an rate of patients with successful creation of gastro-enterostomy followed by successfull ERCP via LAMS (lumen apposing metal stent) including all planned interventions

Safety of EDEE

时间窗: during the procedure

number and rate of patients, in whom a procedure related complication occured

次要结局

  • Clinical success rate(at the day of last procedure)
  • Requirement for reinterventions(during the procedure)
  • Technical aspects of gastro-enterostomy(during the procedure)
  • Techinical aspect of ERCP via LAMS(during procedure)

研究者

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

Torsten Beyna

PD Dr. med

Evangelisches Krankenhaus Düsseldorf

研究点 (1)

Loading locations...

相似试验