ClinicalTrials.gg
CompletedNCT03510754(EUS-BD)Updated Jun 11, 2025

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

An observational study in Obstructive Jaundice and Pancreatic Cancer, sponsored by Azienda USL Reggio Emilia - IRCCS. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by Azienda USL Reggio Emilia - IRCCS · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
36
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Obstructive Jaundice
  • Pancreatic Cancer

Keywords

  • Endoscopic ultrasound
  • Biliary drainage
  • Endoscopic ultrasound guided biliary drainage
03

In context

Jaundice, Obstructive

62 studies on the registry are indexed under Jaundice, Obstructive; 15 are open to participants now.

This study's enrollment of 36 is below the median of 125 across 20 observational studies indexed under Jaundice, Obstructive.

Browse Jaundice, Obstructive studies →

Lead sponsor

Azienda USL Reggio Emilia - IRCCS is the lead sponsor of 93 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with benign stricture
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
36 participants (actual)
Patient registry
No

Interventions

  • ProcedureEus guided biliary drainage

    After reaching the cardia or the lesser curvature of the stomach, for the transgastric approach, or the duodenal bulb, for the transduodenal one, intrahepatic left and extrahepatic bile ducts were punctured with a 19-gouge needle and the access was confirmed the injection of contrast under fluoroscopy to obtain an anterograde cholangiogram. A 0.035-inch guide was advanced into the selected bile duct and under EUS and fluoroscopic view a stent was placed through the hepatogastrostomy between a left bile duct and the gastric lumen or through the choledochoduodenostomy between the common bile duct and the duodenal lumen.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

  2. Early clinical success

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

    Time frame: 14 days

  3. late clinical success

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

    Time frame: 30 days

Secondary outcomes

  1. 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.

    Time frame: 30 days

  2. Stent patency

    the time between stent placement and its occlusion

    Time frame: 1 year

  3. 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.

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03510754
Lead sponsor
Azienda USL Reggio Emilia - IRCCS
Responsible party
Sponsor
First posted
Apr 27, 2018
Start date
Jan 1, 2011
Primary completion
Nov 30, 2017
Completion
Dec 8, 2017
Last update
Jun 11, 2025

Study contacts

Romano Sassatelli, MD
study chair · Azienda USL Reggio Emilia - IRCCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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