Trials / Completed
CompletedNCT03494023
EUS Evaluation of CBD Diameter in Malignant Obstructive Jaundice
Endoscopic Ultrasound Evaluation of the Common Bile Duct in Patients With Obstructive Jaundice Due to Bilio-Pancreatic Malignancies: A Multicenter Prospective Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 539 (actual)
- Sponsor
- Clinical Hospital Colentina · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
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.
Conditions
- Pancreatic Cancer
- Cholangiocarcinoma of the Extrahepatic Bile Duct
- Ampulla of Vater Cancer
- Jaundice, Obstructive
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Endoscopic ultrasound | Measurement of the common bile duct diameter |
Timeline
- Start date
- 2018-03-27
- Primary completion
- 2019-12-31
- Completion
- 2020-04-15
- First posted
- 2018-04-11
- Last updated
- 2020-04-28
Locations
1 site across 1 country: Romania
Source: ClinicalTrials.gov record NCT03494023. Inclusion in this directory is not an endorsement.