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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
Sponsor:
Collaborator:
Catholic University, Italy
Information provided by (Responsible Party):
Mihai Rimbas, Clinical Hospital Colentina

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Pancreatic Cancer Cholangiocarcinoma of the Extrahepatic Bile Duct Ampulla of Vater Cancer Jaundice, Obstructive Diagnostic Test: Endoscopic ultrasound

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.

Study Design
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Study Type : Observational
Actual Enrollment : 539 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: Endoscopic ultrasound
    Measurement of the common bile duct diameter

Outcome Measures
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Primary Outcome Measures :
  1. Common bile duct diameter [ Time Frame: Enrollment over 6 months ]
    Measurement by endoscopic ultrasound in patients with malignant obstructive jaundice


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Romania
Gastroenterology Department, Clinical Hospital Colentina
Bucharest, Romania, 020125
Sponsors and Collaborators
Clinical Hospital Colentina
Catholic University, Italy
Investigators
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Principal Investigator: Mihai Rimbas, MD, PhD Clinical Hospital Colentina
More Information
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Responsible Party: Mihai Rimbas, Assistant Professor, Clinical Hospital Colentina
ClinicalTrials.gov Identifier: NCT03494023    
Other Study ID Numbers: Col-gastro 7
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cholangiocarcinoma
Jaundice
Jaundice, Obstructive
Neoplasms
Adenocarcinoma
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations