Pancreatic Cancer Clinical Trial
Official title:
Endoscopic Ultrasound-Guided Biliary Drainage (EUS-BD) Compared to Standard Transpapillary Biliary Drainage (ERCP-TP) for Palliation of Jaundice in Unresectable Cancer of the Head of the Pancreas (BILPAL TRIAL)
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.
Obstructive jaundice is the most common symptom in patients with periampullary cancer and
cancer of the pancreatic head. For patients with unresectable tumors, palliation of
malignant obstructive is traditionally achieved using endoscopic retrograde
cholangiopancreatography (ERCP) with transpapillary (TP) stent placement. Data show that
ERCP is equivalent to surgery with regards to relief of jaundice. Self-expandable metal
stents (SEMS) offer prolonged palliation compared to large-bore (10Fr) plastic stents.
However, it is believed that gastric outlet obstruction occurs more commonly in patients who
have received SEMS for palliation of MOJ. In addition, ERCP is associated with adverse
events including pancreatitis, post-sphincterotomy bleeding, and perforation.
More recently endoscopic ultrasound (EUS)-guided biliary drainage has been described for
biliary drainage in patients with malignant distal bile duct obstruction. Thus far it has
been used as a rescue approach when traditional ERCP-guided transpapillary biliary drainage
ERCP fails. TP failure can occur as a result of duodenal obstruction, failed cannulation,
and failed wire access across the stricture.
Potential advantages of EUS-guided biliary drainage include avoidance of pancreatitis and
post-sphincterotomy bleeding. Additionally, it may result in a lower frequency of gastric
outlet obstruction since the stent does not encroach upon the tumor.
To compare the potential advantages of EUS-guided biliary drainage the investigators are
conducting a multicenter, randomized trial comparing the EUS-guided drainage to traditional
ERCP.
This EUS-BD vs. 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.
This study will enroll 120 subjects; 60 subjects in each arm. Trial duration is about 1 year
and involves 5-7 visits.
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