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| Name | Class |
|---|---|
| Catholic University, Italy | OTHER |
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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.
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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic ultrasound | Diagnostic Test | Measurement of the common bile duct diameter |
| Measure | Description | Time Frame |
|---|---|---|
| Common bile duct diameter | Measurement by endoscopic ultrasound in patients with malignant obstructive jaundice | Enrollment over 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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This study concerns individuals with jaundice with an indication for EUS examination of a pancreatic head solid lesion, a distal CBD mass, or a carcinoma of the ampulla of Vater who undergo diagnostic EUS-guided tissue acquisition or for evaluation of resectability, discovered at previously performed imaging studies. Only patients with a definitive diagnosis of neoplasia will enter in the final analysis. Eligible individuals will be recruited by endosonographers among the centers of the ECCO study group.
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| Name | Affiliation | Role |
|---|---|---|
| Mihai Rimbas, MD, PhD | Clinical Hospital Colentina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastroenterology Department, Clinical Hospital Colentina | Bucharest | 020125 | Romania |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D041781 | Jaundice, Obstructive |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D019160 | Endosonography |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D007565 | Jaundice |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |