EUS Evaluation of CBD Diameter in Malignant Obstructive Jaundice

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Endoscopic Ultrasound Evaluation of the Common Bile Duct in Patients With Obstructive Jaundice Due to Bilio-Pancreatic Malignancies: A Multicenter Prospective Study

Conditions
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Pancreatic Cancer, Cholangiocarcinoma of the Extrahepatic Bile Duct, Ampulla of Vater Cancer, Jaundice, Obstructive

Intervention / Treatment
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* Diagnostic Test: Endoscopic ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with jaundice and a pancreatic head mass lesion referred for EUS-guided tissue acquisition or staging Patients with jaundice and a distal CBD lesion suggestive of cholangiocarcinoma or a carcinoma of the ampulla of Vater referred for EUS-guided tissue acquisition or staging Serum bilirubin level ≥3 mg/dL Age ≥18 years Written informed consent Exclusion Criteria: Presence of altered anatomy from previous gastric surgery (Billroth II or Roux-en-Y anastomosis) Previously performed sphincterotomy, biliary plastic stent or metal stent placement Previous percutaneous drainage of the bile duct Pregnancy Inability to sign the informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Endoscopic ultrasound|Measurement of the common bile duct diameter|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Common bile duct diameter | Measurement by endoscopic ultrasound in patients with malignant obstructive jaundice | Enrollment over 6 months |