Actively Recruiting
ERCP With and Without EUS Guided HGS for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
Led by Mansoura University · Updated on 2024-09-26
72
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A prospective randomized clinical trial to evaluate efficacy and safety of combined EUS-HGS and ERCP compared to ERCP for bilateral biliary decompression in advanced malignant hilar biliary obstruction. The primary outcome will be technical success, clinical success, procedural duration, and re-interventions. Secondary outcomes will be the rate of adverse events. patients will be followed up at 1 and 3 month intervals
CONDITIONS
Official Title
ERCP With and Without EUS Guided HGS for Bilateral Biliary Decompression in Malignant Hilar Biliary Obstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of inoperable malignant hilar biliary obstruction confirmed by imaging (magnetic resonance cholangiography, computed tomography, or direct cholangiography) classified as Bismuth type III or 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)
- No narrowing or obstruction in the duodenum
- Willingness to participate and share data in the study
You will not qualify if you...
- Pregnancy
- Distal biliary obstruction as the main lesion
- Benign biliary stenosis
- Malignant hilar biliary obstruction classified as Bismuth type I or II
- Presence of duodenal obstruction
- Surgically altered anatomy or inability to access the major duodenal papilla
- Previous biliary drainage intervention
- Previous failed biliary cannulation at ERCP
- Large volume ascites
- Unfit for anesthesia
- Uncorrectable coagulopathy or thrombocytopenia
- History of allergy to radiocontrast agents
- Refusal to participate or share data in the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mansoura univeristy
Al Mansurah, Dakahlia Governorate, Egypt, 35511
Actively Recruiting
Research Team
M
Mennatallah E Saad, Asslecturer
CONTACT
A
Ahmed Y Altonbary, Assprofessor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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