Status:
COMPLETED
EUS-Guided Choledochoduodenostomy Versus ERCP for Primary Biliary Decompression in Distal Malignant Biliary Obstruction
Lead Sponsor:
Mansoura University
Conditions:
Malignant Biliary Obstruction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Malignant biliary obstruction commonly caused by pancreatic adenocarcinoma, cholangiocarcinoma and other etiologies like gallbladder carcinoma, hepatocellular carcinoma, lymphoma, and metastasis to re...
Detailed Description
This study will be a single center, prospective randomized comparative study that includes 50 patients with distal malignant biliary obstruction including pancreatic head masses, distal cholangiocarci...
Eligibility Criteria
Inclusion
- Age: 18 years and older.
- Presence of locally advanced or metastatic pancreatic head mass on CT or magnetic resonance imaging of the abdomen
- Absence of duodenal obstruction.
- Elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal (1.2 mg/dL).
- Histologic or cytologic diagnosis of malignancy.
- Accept sharing in the study.
Exclusion
- Age younger than 18 years.
- Pregnancy.
- Hilar biliary obstruction (as the main lesion or coexisting with distal obstruction).
- Presence of duodenal obstruction.
- Histologic or cytologic diagnosis of malignancy.
- Patients underwent previous intervention for biliary drainage.
- Previously failed biliary cannulation at ERCP.
- Prior biliary sphincterotomy or stent placement.
- Surgically altered anatomy or inability to access the major duodenal papilla.
- Patients unfit for anesthesia.
- Patients having uncorrectable coagulopathy or thrombocytopenia.
- History of allergy to radiocontrast agents.
- Refuse sharing in the study.
Key Trial Info
Start Date :
July 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04898777
Start Date
July 1 2021
End Date
July 1 2024
Last Update
December 27 2024
Active Locations (1)
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1
Specialized Medical Hospital
Al Mansurah, Dakahlia Governorate, Egypt, 35516