Endoscopic Ultrasonography Guided Biliary Drainage

Malignant Hepatobiliary Neoplasm Clinical Trial

Official title: Endoscopic Ultrasonography-Guided Biliary Drainage Versus Percutaneous Trans-hepatic Biliary Drainage for Malignant Biliary Obstruction After Failed Endoscopic Retrograde Cholangio-pancreaticography

Status Not yet recruiting

Clinical Trial Summary

Endoscopic ultrasonography is a widely accepted modality for the diagnosis of gastrointestinal and pancreatic-biliary diseases.

Endoscopic ultrasonography-guided biliary drainage has attracted attention as an alternative procedure to percutaneous trans-hepatic biliary drainage, with a technical success between 75%-100% and with low complication rate. Other important advantage of endoscopic ultrasonography-guided biliary drainage compared with external percutaneous trans-hepatic biliary drainage is better quality of life due to the internal placement of the stent.

Clinical Trial Description

If endoscopic retrograde cholangio-pancreaticography fails to achieve biliary drainage, more invasive options are usually considered. These include percutaneous trans-hepatic biliary drainage and surgical intervention but they have been associated with a higher risk of complications and prolonged hospital stay.

Some disadvantages with the percutaneous approach include the need to traverse the liver, a decreased quality of life due to the presence of external drainage and a significant morbidity and mortality, 7% and 5% respectively.

The external drainage of percutaneous trans-hepatic biliary drainage may add to the patient's burden owing to the cosmetic problem, skin inflammation or pain, or bile leakage, compromising the quality of life. From this point, the internal drainage of endoscopic ultrasonography-guided biliary drainage eliminates several issues.

Endoscopic ultrasonography-guided biliary drainage using a metal stent, particularly a lumen-apposing metal stent, can also be performed in patients with a large amount of ascites, which is often contraindicated in percutaneous trans-hepatic biliary drainage. Endoscopic ultrasonography-guided biliary drainage performed in the same session of the failed endoscopic retrograde cholangio-pancreaticography, in the same room and under the same sedation.

On the other hand, the endoscopic ultrasonography-guided biliary drainage, has major limitation due to fewer cases reported till date and lack of long term data. Because of, the technical difficulty encountered during re-intervention and problem of stent migration, the expertise needed for such procedure is a major limitation of the techniques.

Furthermore, comparative studies of endoscopic ultrasonography-guided biliary drainage versus percutaneous trans-hepatic biliary drainage are required to select the optimal candidates and to best evaluate the technical and treatment outcomes also in terms of quality of life and costs. Recently, Endoscopic ultrasonography-guided biliary drainage has been introduced as an alternative for patients who had failed endoscopic retrograde cholangio-pancreaticography.

Indications for endoscopic ultrasonography-guided biliary drainage:

1. Failed conventional endoscopic retrograde cholangio-pancreaticography.

2. Altered anatomy

3. Tumor preventing access into the biliary tree

4. Prior surgical procedure

5. Biliary sphincter stenosis

6. Contra-indication to percutaneous access ;

Related Conditions & MeSH terms

• Malignant Hepatobiliary Neoplasm

• NCT number: NCT03195075
• Study type: Interventional
• Source: Assiut University
• Contact: Mohamed El-Yamany, MD
• Phone: 01002228914
• Email: elyamany72@yahoo.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2018
• Completion date: September 2020