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

NCT03510754 | Completed

• 1 other identifier: CORE002
• Study Type: observational
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Obstructive Jaundice; Pancreatic Cancer

Keywords

Endoscopic ultrasound; Biliary drainage; Endoscopic ultrasound guided biliary drainage

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Procedure-related adverse events

  30 days

• Stent patency

  1 year

• Re-stenting

  1 year

Interventions

Eus guided biliary drainage PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• Patients with benign stricture

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

MeSH Terms

Conditions

Jaundice, Obstructive; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Romano Sassatelli, MD

  Azienda USL Reggio Emilia - IRCCS

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 27, 2018
• Study Start: January 1, 2011
• Primary Completion: November 30, 2017
• Study Completion: December 8, 2017
• Last Updated: June 11, 2025

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share