ERCP With and Without EUS Guided HGS for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
NCT ID: NCT06613945
Last Updated: 2024-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
72 participants
INTERVENTIONAL
2024-09-01
2026-10-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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
Combined ERCP and EUS-HGS 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.
ERCP biliary drainage
bilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage
ERCP biliary drainage
bilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage
Interventions
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ERCP biliary drainage
bilateral metallic stents insertion will be attempted through ERCP to secure biliary drainage
Combined ERCP and EUS-HGS 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Principal Investigators
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Mennatallah E saad, asslecturer
Role: PRINCIPAL_INVESTIGATOR
Mansoura University
Locations
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Mansoura univeristy
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MD.24.08.881
Identifier Type: -
Identifier Source: org_study_id
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