EUS Evaluation of CBD Diameter in Malignant Obstructive Jaundice (ECCO)

Endoscopic Ultrasound Evaluation of the Common Bile Duct in Patients With Obstructive Jaundice Due to Bilio-Pancreatic Malignancies: A Multicenter Prospective Study

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer; Jaundice, Obstructive; Cholangiocarcinoma of the Extrahepatic Bile Duct; Ampulla of Vater Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 539

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania, 020125
    • Gastroenterology Department, Clinical Hospital Colentina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Common bile duct diameter	Measurement by endoscopic ultrasound in patients with malignant obstructive jaundice	Enrollment over 6 months

Collaborators and Investigators

• Sponsor: Clinical Hospital Colentina
• Collaborators: Catholic University, Italy
• Investigators: Principal Investigator: Mihai Rimbas, MD, PhD, Clinical Hospital Colentina

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): April 15, 2020

Study Registration Dates

• First Submitted: March 31, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (Actual): April 11, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 26, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Skin Manifestations; Hyperbilirubinemia; Cholangiocarcinoma; Jaundice; Jaundice, Obstructive
• Other Study ID Numbers: Col-gastro 7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No