Pancreatic Cancer Clinical Trial
Official title:
Endoscopic Ultrasound Evaluation of the Common Bile Duct in Patients With Obstructive Jaundice Due to Bilio-Pancreatic Malignancies: A Multicenter Prospective Study
The main objective of the study is to evaluate the size of the common bile duct (CBD) in a large cohort of patients with jaundice secondary to pancreatic head or distal bile duct malignancy undergoing diagnostic EUS for tissue acquisition or evaluation of resectability and to establish factors associated with a dilation of the CBD greater than 15mm.
Rationale: The size of the common bile duct (CBD) may influence the type of stent used and
the type of the procedure performed in cases of EUS-guided biliary drainage. However, no data
of the size of the CBD in patients with jaundice presenting with a pancreatic head mass or
with a distal cholangiocarcinoma/ carcinoma of the ampulla of Vater are available.
Objectives: To evaluate the size of the CBD in a large cohort of patients with jaundice
secondary to pancreatic head or distal bile duct malignancy undergoing diagnostic EUS for
tissue acquisition or evaluation of resectability and to establish factors associated with a
dilation of the CBD greater than 15mm.
Study design: International prospective observational multicenter trial. Study population:
Patients ≥18 years old, referred for EUS-guided tissue sampling or evaluation of
resectability of a pancreatic, a distal bile duct lesion or a carcinoma of the ampulla of
Vater determining obstructive jaundice.
Intervention: EUS examination Main study parameters/endpoints: measurement of the CBD in
patients with an obstructive distal biliary mass. Determine the factors associated with a CBD
greater than 15mm Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: Measurement of the CBD during EUS examination does not add
additional risks to the procedure.
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