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Endoscopic Ultrasound-guided Biliary Drainage for Malignant Biliary Obstruction After Failed ERCP


2011-01-01


2017-11-30


2017-12-08


36

Study Overview

Endoscopic Ultrasound-guided Biliary Drainage for Malignant Biliary Obstruction After Failed ERCP

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

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. Definitions: Technical success was defined as 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 was defined as a drop of bilirubin hematic level by 50 % after 2 week from EUS-BD, while late clinical success was considered as the reaching of hematic bilirubin level compatible with a possible chemotherapy treatment at 3-4 weeks after the endoscopic performance. Procedure-related adverse events were recorded and graded as mild if they resolved spontaneously, moderate if they required a specific intervention without the need for an extension of hospitalization and severe in case of death or if they required a specific intervention (surgical or not) with consequent prolongation of hospitalization. Stent patency duration was defined as the time between stent placement and its occlusion Re-stenting was defined as the necessary to second EUS-guided stent placement in patients who didn't achieve early clinical success or in the case of jaundice recurrence from the first treatment.

  • Obstructive Jaundice
  • Pancreatic Cancer
  • PROCEDURE: Eus guided biliary drainage
  • CORE002

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2018-04-06  

N/A  

2018-04-26  

2018-04-26  

N/A  

2018-04-27  

2018-04-27  

N/A  

2018-04  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
Primary Outcome MeasuresMeasure DescriptionTime Frame
Technical successthe correct placement of the metal or plastic stent across the stomach or duodenum to the chosen biliary branch, with radiologically and endoscopically confirmed.1 day
Early clinical successdrop of bilirubin hematic level by 50 % after 2 week from EUS-BD14 days
late clinical successas the reaching of hematic bilirubin level compatible with a possible chemotherapy treatment at 3-4 weeks after the endoscopic performance30 days
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Procedure-related adverse eventsgraded as mild if they resolved spontaneously, moderate if they required a specific intervention without the need for an extension of hospitalization and severe in case of death or if they required a specific intervention (surgical or not) with consequent prolongation of hospitalization.30 days
Stent patencythe time between stent placement and its occlusion1 year
Re-stentingthe necessary to second EUS-guided stent placement in patients who didn't achieve early clinical success or in the case of jaundice recurrence from the first treatment.1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

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

  • Exclusion Criteria:

  • Patients with benign stricture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • STUDY_CHAIR: Romano Sassatelli, MD, Azienda USL Reggio Emilia - IRCCS

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available