Endoscopic Ultrasound-guided Biliary Drainage for Malignant Biliary Obstruction After Failed ERCP ((EUS-BD))

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

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

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Obstructive Jaundice
• Intervention / Treatment: Procedure: Eus guided biliary drainage

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 36

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients afferent to Santa Maria Nuova Hospital in Reggio Emilia, between January 2011 and November 2017, with malignant obstructive jaundice, in whom ERCP had failed

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with benign stricture

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	the 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 success	drop of bilirubin hematic level by 50 % after 2 week from EUS-BD	14 days
late clinical success	as the reaching of hematic bilirubin level compatible with a possible chemotherapy treatment at 3-4 weeks after the endoscopic performance	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure-related adverse events	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.	30 days
Stent patency	the time between stent placement and its occlusion	1 year
Re-stenting	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.	1 year

Collaborators and Investigators

• Sponsor: Arcispedale Santa Maria Nuova-IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): December 8, 2017

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: April 26, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 27, 2018
• Last Update Submitted That Met QC Criteria: April 26, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Biliary drainage; Endoscopic ultrasound; Endoscopic ultrasound guided biliary drainage
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Manifestations; Hyperbilirubinemia; Jaundice; Jaundice, Obstructive
• Other Study ID Numbers: CORE002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No