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Endoscopic Ultrasonography Guided Biliary Drainage

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ClinicalTrials.gov Identifier: NCT03195075
Recruitment Status : Not yet recruiting
First Posted : June 22, 2017
Last Update Posted : June 22, 2017
Sponsor:
Information provided by (Responsible Party):
Abdelhamed Mohamed, 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.


Condition or disease Intervention/treatment Phase
Malignant Hepatobiliary Neoplasm Procedure: Endoscopic ultrasonography guided biliary drainage Procedure: Percutaneous trans-hepatic biliary drainage Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Endoscopic Ultrasonography-Guided Biliary Drainage Versus Percutaneous Trans-hepatic Biliary Drainage for Malignant Biliary Obstruction After Failed Endoscopic Retrograde Cholangio-pancreaticography
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Ultrasound

Arm Intervention/treatment
Active Comparator: Group 1
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
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

Active Comparator: Group 2
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
Percutaneous trans-hepatic biliary drainage in interventional radiology department using self-expandable metal stent will be done for group 2




Primary Outcome Measures :
  1. Laboratory evaluation of efficacy of endoscopic ultrasonography and percutaneous trans-hepatic biliary drainage in malignant biliary obstruction. [ Time Frame: 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

  2. Radiological evaluation of efficacy of endoscopic ultrasonography and percutaneous trans-hepatic biliary drainage in malignant biliary obstruction [ Time Frame: 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 :
  1. Evaluation of post-procedural complications [ Time Frame: Within six months from procedure. ]
    Evaluation of biliary leakage by ultrasound, hemorrhage by hemoglobin level, perforation and stent potency.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195075


Contacts
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Contact: Mohamed El-Yamany, MD 01002228914 elyamany72@yahoo.com
Contact: wael Ahmed, MD 01064236064 drwaelabbas@yahoo.com

Sponsors and Collaborators
Assiut University

Publications:

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Responsible Party: Abdelhamed Mohamed, Principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03195075     History of Changes
Other Study ID Numbers: EUS
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No