Endoscopic Ultrasonography Guided Biliary Drainage

Not Applicable

• Conditions: Malignant Hepatobiliary Neoplasm
• Interventions: Procedure: Endoscopic ultrasonography guided biliary drainage; Procedure: Percutaneous trans-hepatic biliary drainage

• Registration Number: NCT03195075
• Lead Sponsor: Assiut University

Brief 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.

Detailed 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

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Status Verified: 2017-06
• Study First Submitted: 2017-06-04
• Study First Submitted QC: 2017-06-21
• Last Update Submitted: 2017-06-21
• Study First Posted: 2017-06-22
• Last Update Posted: 2017-06-22
• Study Start: 2018-01
• Primary Completion: 2020-01
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Endoscopic ultrasonography guided biliary drainage	20 Patients with malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography will be subjected to endoscopic ultrasonography guided biliary drainage
Group 2	Percutaneous trans-hepatic biliary drainage	20 Patients with malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography will be subjected to percutaneous trans-hepatic biliary drainage.

Primary Outcome Measures

Name	Time	Method
Laboratory evaluation of efficacy of endoscopic ultrasonography and percutaneous trans-hepatic biliary drainage in malignant biliary obstruction.	Liver function test before the procedure and follow up changes after one week from procedures.	Evaluation of serum bilirubin and alkaline phosphatase by liver function test before and after the procedures
Radiological evaluation of efficacy of endoscopic ultrasonography and percutaneous trans-hepatic biliary drainage in malignant biliary obstruction	Biliary dilation before the procedures and follow up changes after one week from procedures.	Evaluation of biliary dilation by abdominal ultrasonography before and after the procedures,

Secondary Outcome Measures

Name	Time	Method
Evaluation of post-procedural complications	Within six months from procedure.	Evaluation of biliary leakage by ultrasound, hemorrhage by hemoglobin level, perforation and stent potency.