EUS Evaluation of CBD Diameter in Malignant Obstructive Jaundice (ECCO)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03494023|
Recruitment Status : Completed
First Posted : April 11, 2018
Last Update Posted : April 28, 2020
|Condition or disease||Intervention/treatment|
|Pancreatic Cancer Cholangiocarcinoma of the Extrahepatic Bile Duct Ampulla of Vater Cancer Jaundice, Obstructive||Diagnostic Test: Endoscopic ultrasound|
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.
|Study Type :||Observational|
|Actual Enrollment :||539 participants|
|Official Title:||Endoscopic Ultrasound Evaluation of the Common Bile Duct in Patients With Obstructive Jaundice Due to Bilio-Pancreatic Malignancies: A Multicenter Prospective Study|
|Actual Study Start Date :||March 27, 2018|
|Actual Primary Completion Date :||December 31, 2019|
|Actual Study Completion Date :||April 15, 2020|
- Diagnostic Test: Endoscopic ultrasound
Measurement of the common bile duct diameter
- Common bile duct diameter [ Time Frame: Enrollment over 6 months ]Measurement by endoscopic ultrasound in patients with malignant obstructive jaundice
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03494023
|Gastroenterology Department, Clinical Hospital Colentina|
|Bucharest, Romania, 020125|
|Principal Investigator:||Mihai Rimbas, MD, PhD||Clinical Hospital Colentina|