EUS BD vs ERCP TP for Pancreatic Cancer
Status unconfirmed · Not applicable
Conditions studied: Pancreatic Cancer, Pancreatic Adenocarcinoma, Biliary Tract Neoplasms, Biliary Duct Obstruction, Unresectable Pancreatic Cancer, Periampullary Cancer, Periampullary Carcinoma Non-Resectable
In brief
This Endoscopic Ultrasound guided Biliary Drainage (EUS-BD) vs. Endoscopic Retrograde Cholangiopancreatography (ERCP-TP) trial (BILPAL) is a randomized controlled multicenter trial that will provide evidence whether or not traditional ERCP biliary drainage is to be performed in patients with obstruction in bile duct due to unresectable pancreatic head or periampullary tumor.
Key facts
- Study ID
- NCT03063554
- Run by
- Weill Medical College of Cornell University
- People needed
- 120
- Starts
- 2016-10-18
- Expected to finish
- 2018-10-01
- Last updated by the study team
- 2017-02-24
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age between 18 and 90 years old
- Clinically indicated for biliary endoscopic drainage with Endoscopic Ultrasound guidance or ERCP
- CT scan has demonstrated a lesion in the pancreatic head area with metastases and/ or local tumor ingrowth preventing resection.
- CT with evidence of distant metastases or local tumor ingrowth into portal or mesenteric vessels (as defined by the tumor surrounding the vessel for at least 180 degrees of the circumference)
- A serum bilirubin level of > 2.5mg/dL at randomization
- Deemed surgically unresectable
- Consents to participation in the randomized controlled trial
You may not qualify if…
- > 90 years
- Severe comorbidity (Karnofsky <50%)
- Any prior successful previous biliary drainage including ERCP and stenting, percutaneous biliary and surgical,
- Prior surgically altered pancreaticobiliary or gastroduodenal anatomy.
- Female of childbearing potential with a positive pregnancy test prior to the procedure or intends to become pregnant during the study.
- Currently participating in another device trial that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
Where it is running
- Weill Cornell Medical College — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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