An observational study in Pancreatic Cancer, Cholangiocarcinoma of the Extrahepatic Bile Duct and Ampulla of Vater Cancer, sponsored by Clinical Hospital Colentina. Completed at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-28.
Sponsored by Clinical Hospital Colentina · Observational
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.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's enrollment of 539 is above the median of 200 across 740 observational studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Clinical Hospital Colentina is the lead sponsor of 14 studies on the registry; 2 are open to participants now.
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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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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurement of the common bile duct diameter
Common bile duct diameter
Measurement by endoscopic ultrasound in patients with malignant obstructive jaundice
Time frame: Enrollment over 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Clinical Hospital Colentina