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Obstructive Jaundice(EUS-BD)NCT03510754

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

An observational study of Obstructive Jaundice and Pancreatic Cancer, run by Azienda USL Reggio Emilia - IRCCS.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obstructive Jaundice, Pancreatic Cancer
What is being tested?
Eus guided biliary drainage
How many people
36 participants
Where
No sites listed yet
Study dates
1 Jan 2011to 8 Dec 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Patients with benign stricture

About this study

Official title: 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

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.

Being tested
Eus guided biliary drainage
Keywords
Endoscopic ultrasound, Biliary drainage, Endoscopic ultrasound guided biliary drainage
Medical subject headings
Jaundice, Obstructive, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Eus guided biliary drainageProcedure or surgery

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 day

  2. Early clinical success

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

    Measured: 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

    Measured: 30 days

Secondary outcomes (3)
  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.

    Measured: 30 days

  2. Stent patency

    the time between stent placement and its occlusion

    Measured: 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2018
  2. Study start1 Jan 2011
  3. Primary completion30 Nov 2017
  4. Study completion8 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03510754
Sponsor's protocol ID
CORE002
Acronym
(EUS-BD)
Status last verified
Apr 2018
First submitted
6 Apr 2018
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Jaundice and Pancreatic Cancer, run by Azienda USL Reggio Emilia - IRCCS.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical success (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.

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