UnknownNot Applicable

EUS BD vs ERCP TP for Pancreatic Cancer

United States120 participantsStarted 2016-10-18

Plain-language summary

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.

Who can participate

Age range18 Years – 90 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. \> 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.

What they're measuring

Efficacy of Stent Patency

Timeframe: 6 months after randomization

Trial details

NCT IDNCT03063554

SponsorWeill Medical College of Cornell University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-09-01

Contact for this trial

Michel Kahaleh, MD

646-962-4797 mik9071@med.cornell.edu

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