Endoscopic Ultrasonography Guided Biliary Drainage

Assiut University

Status: Unknown

Conditions: Malignant Hepatobiliary Neoplasm

Treatments: Procedure: Endoscopic ultrasonography guided biliary drainage; Procedure: Percutaneous trans-hepatic biliary drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT03195075

EUS

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Presence of un-resectable malignant distal biliary obstruction.
2. Failed conventional endoscopic retrograde cholangio-pancreaticography and inaccessible papilla because of accompanying duodenal obstruction, peri-ampullary tumor infiltration, ampulla stenosis, or surgically altered anatomy (Billroth II operation, Roux-an-Y operation).
3. Histological or cytological diagnosis of malignancy
4. No serious or uncontrolled medical illness

Exclusion criteria

1. Patient age of less than 18 years
2. Uncorrectable coagulopathy
3. History of allergy to radio-contrast agents
4. Refusal to participate in this study
5. Severs co-existed cardiopulmonary and /or renal disease
6. Low platelet count (50000/μL)
7. Patients with disturbed conscious level

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Group 1

Active Comparator group

Description:

20 Patients with malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography will be subjected to endoscopic ultrasonography guided biliary drainage

Treatment:

Procedure: Endoscopic ultrasonography guided biliary drainage

Group 2

Active Comparator group

Description:

20 Patients with malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography will be subjected to percutaneous trans-hepatic biliary drainage.

Treatment:

Procedure: Percutaneous trans-hepatic biliary drainage