Endoscopic Ultrasonography Guided Biliary Drainage

Study Overview
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Brief Summary
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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
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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: Failed conventional endoscopic retrograde cholangio-pancreaticography. Altered anatomy Tumor preventing access into the biliary tree Prior surgical procedure Biliary sphincter stenosis Contra-indication to percutaneous access

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

Conditions
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Malignant Hepatobiliary Neoplasm

Intervention / Treatment
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* Procedure: Endoscopic ultrasonography guided biliary drainage
* Procedure: Percutaneous trans-hepatic biliary drainage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of un-resectable malignant distal biliary obstruction. 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). Histological or cytological diagnosis of malignancy No serious or uncontrolled medical illness Exclusion Criteria: Patient age of less than 18 years Uncorrectable coagulopathy History of allergy to radio-contrast agents Refusal to participate in this study Severs co-existed cardiopulmonary and /or renal disease Low platelet count (50000/μL) Patients with disturbed conscious level
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This study will include 40 consecutive jaundiced patients with distal malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography. Twenty patients with failed endoscopic retrograde cholangio-pancreaticography will be subjected to endoscopic ultrasonography-guided biliary drainage will be performed by single endoscopist and another 20 patients with failed endoscopic retrograde cholangio-pancreaticography for percutaneous trans-hepatic biliary drainage.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>20 Patients with malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography will be subjected to endoscopic ultrasonography guided biliary drainage | Procedure: Endoscopic ultrasonography guided biliary drainage<br>* Endoscopic ultrasonography guided biliary drainage includes rendezvous techniques, endoscopic ultrasonography guided choledochoduodenostomy, and endoscopic ultrasonography-guided hepatogastrostomy using self-expandable metal stent will be done for group 1<br>|
| Active Comparator: Group 2<br>20 Patients with malignant biliary obstruction after failed endoscopic retrograde cholangio-pancreaticography will be subjected to percutaneous trans-hepatic biliary drainage. | Procedure: Percutaneous trans-hepatic biliary drainage<br>* Percutaneous trans-hepatic biliary drainage in interventional radiology department using self-expandable metal stent will be done for group 2<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of post-procedural complications | Evaluation of biliary leakage by ultrasound, hemorrhage by hemoglobin level, perforation and stent potency. | Within six months from procedure. |