ERCP With and Without EUS Guided HGS for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
Endoscopic Retrograde Cholangiopancreatography With and Without Endoscopic Ultrasound Guided Hepaticogastrostomy for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Bilateral stenting by Endoscopic Retrograde Cholangiopancreatography in malignant hilar biliary obstructions (MHBO) is challenging and technically difficult. EUS hepaticogastrostomy (EUS-HGS) has been increasingly used as an alternative method to achieve internal biliary drainage in MHBO. Because of the difficulty of ERCP in such scenario, the combination of EUS-HGS and ERCP provides a possible chance of longer stent patency with less event of stent clogging Aim of the work: to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced MHBO.
The inclusion criteria will be presence of inoperable MHBO with elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal The study patients will be randomized in 1:1 ratio to: ERCP biliary drainage (ERCP-BD) group: bilateral metallic stents insertion will be attempted by transpapilary approach. Combined ERCP and EUS-HGS group: unilateral metallic stent will be inserted on right side by transpapilary approach and a transmural stent will be inserted on left side by EUS.
technical success, clinical success, procedural duration, and re-interventions and adverse events will be assesed
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mennatallah E Saad, Asslecturer
- Phone Number: 0502200590 0502200590
- Email: mennaehab@mans.edu.eg
Study Contact Backup
- Name: Ahmed Y Altonbary, Assprofessor
- Phone Number: 0502200590 0502200590
- Email: a.tonbary@gmail.com
Study Locations
-
-
Dakahlia
-
Mansoura, Dakahlia, Egypt, 35511
- Recruiting
- Mansoura Univeristy
-
Contact:
- Ahmed Y Altonbary, Assprofessor
- Phone Number: +2 +20 100 5100091
- Email: a.tonbary@gmail.com
-
Contact:
- Mennatallah E Saad, Asslecturer
- Phone Number: +2 +20 122 2449220
- Email: mennaehab@mans.edu.eg
-
Principal Investigator:
- Mennatallah E Saad, Asslecturer
-
Sub-Investigator:
- Ahmed Y Altonbary, Assprofessor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Presence of inoperable malignant hilar biliary obstruction on magnetic resonance cholangiography, computed tomography and/or direct cholangiography bismuth type III & IV only.
- Histologically confirmed malignant hilar biliary obstruction.
- Elevated serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL).
- Absence of duodenal narrowing/obstruction.
- Accept sharing in the study
Exclusion Criteria:
- Pregnancy.
- Distal biliary obstruction as the main lesion.
- Benign biliary stenosis.
- Malignant hilar biliary obstruction bismuth type I and II.
- Presence of duodenal obstruction.
- Surgically altered anatomy or inability to access the major duodenal papilla.
- Patients underwent previous intervention for biliary drainage.
- Previously failed biliary cannulation at ERCP.
- Large volume ascites.
- Patients unfit for anesthesia.
- Patients having uncorrectable coagulopathy or thrombocytopenia.
- History of allergy to radiocontrast agents.
- Refuse sharing in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Combined EUS-HGS and ERCP biliary drainage
unilateral metallic stent will be inserted on right side through ERCP and a hepaticogastrostomy transmural stent will be inserted on left side by EUS to secure biliary drainage
|
unilateral metallic stent will be inserted on right side by ERCP and a hepaticogastrostomy transmural stent will be inserted on left side by EUS to secure biliary drainage.
|
|
Active Comparator: ERCP biliary drainage
bilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage
|
bilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Technical success
Time Frame: during the procedure
|
considered after stent placement (expanded and patent) with good bile flow and drainage
|
during the procedure
|
|
Procedural duration
Time Frame: at the end of the procedure
|
defined as time from biliary cannulation to stent placement by ERCP, and time from needle puncture of the dilated bile duct to stent placement by EUS
|
at the end of the procedure
|
|
Clinical success
Time Frame: 3 month
|
considered at 2 weeks by a 50% decrease in total bilirubin levels from baseline and at 4 weeks if total bilirubin is less than 3mg/dL.
|
3 month
|
|
Re-interventions
Time Frame: 3 month
|
need for re-intervention to secure biliary drainage
|
3 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse events
Time Frame: 3 month
|
Early adverse events (within 48 hours after procedure) including: pancreatitis, cholangitis, bleeding, perforation and peritonitis. - Late adverse events include stent dysfunction either due to food impaction, tumor ingrowth or stent migration |
3 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mennatallah E saad, asslecturer, Mansoura University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MD.24.08.881
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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