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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
- Conditions
- Obstructive Jaundice, Pancreatic Cancer
- 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.
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
Early clinical success
drop of bilirubin hematic level by 50 % after 2 week from EUS-BD
Measured: 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
Measured: 30 days
Secondary outcomes (3)
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
Stent patency
the time between stent placement and its occlusion
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 Jan 2011
- Primary completion30 Nov 2017
- Study completion8 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive JaundiceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Romano Sassatelli, MD, Study chair, Azienda USL Reggio Emilia - IRCCS
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-guided Biliary Drainage for Malignant Biliary Obstruction After Failed ERCP: a Single Italian Center Experience
- ClinicalTrials.gov ID
- NCT03510754
- Acronym / sponsor ID
- (EUS-BD) / CORE002
- Conditions
- Obstructive Jaundice, Pancreatic Cancer
- Keywords
- Endoscopic ultrasound, Biliary drainage, Endoscopic ultrasound guided biliary drainage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (1 listed)
- patients over 18 years old, malignant bile duct obstruction with unsuccessful ERCP drainage.
Key exclusion criteria (1 listed)
- Patients with benign stricture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eus guided biliary drainageAfter 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. | Procedure or surgery | – |
Primary outcome
Technical success
Time frame: 1 day
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
Time frame: 14 days
drop of bilirubin hematic level by 50 % after 2 week from EUS-BD
late clinical success
Time frame: 30 days
as the reaching of hematic bilirubin level compatible with a possible chemotherapy treatment at 3-4 weeks after the endoscopic performance
3 secondary outcomes
Procedure-related adverse events
Time frame: 30 days
Stent patency
Time frame: 1 year
Re-stenting
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romano Sassatelli, MD study chair
Azienda USL Reggio Emilia - IRCCS
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.