Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction

Completed · Not applicable

Conditions studied: Pancreatic Cancer, Pancreatic Neoplasms, Pancreatic Adenocarcinoma

In brief

The purpose of this study is to compare the rates of adverse events between patients undergoing Endoscopic Ultrasound- guided biliary drainage and Endoscopic Retrograde Cholangiopancreatography for distal malignant biliary obstruction.

Key facts

Study ID

NCT03054987

Run by

AdventHealth

People needed

67

Starts

2016-09-01

Expected to finish

2018-10-01

Last updated by the study team

2019-02-15

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• ≥ 18 years of age.
• Has jaundice due to malignant distal (more than 3cm distal to liver hilum) biliary obstruction.
• The subject (or when applicable the subject's LAR) is able to understand and willing to sign an informed consent form prior to the initiation of any study procedures.

You may not qualify if…

• Age <18 years
• Females who are pregnant or lactating. Pregnancy in females of childbearing potential will be determined by routine preoperative urine HCG testing.
• Coagulopathy which cannot be corrected (INR >1.6, thrombocytopenia with platelet count <50,000/ml)
• Has surgically altered gastrointestinal anatomy such as but not limited to (Billroth II/Roux en-Y, gastric bypass).
• Liver metastasis involving >30% of liver volume.
• Liver cirrhosis with portal hypertension and/or ascites.

Where it is running

• Center for Interventional Endoscopy - Florida Hospital — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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