EUS Evaluation of CBD Diameter in Malignant Obstructive Jaundice

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.

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Key information

Conditions

Pancreatic Cancer Ampulla of Vater Cancer Cholangiocarcinoma of the Extrahepatic Bile Duct Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Hyperbilirubinemia Jaundice Jaundice, Obstructive Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastroenterology Department, Clinical Hospital Colentina

Bucharest, 020125, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Ultrasound

Diagnostic Test

Measurement of the common bile duct diameter

Primary outcomes

Common bile duct diameter

Time frame: Enrollment over 6 months

Measurement by endoscopic ultrasound in patients with malignant obstructive jaundice

Sponsors and collaborators

Lead sponsor

Clinical Hospital Colentina

Other

Collaborators

Catholic University, Italy

Registry information

Official study title

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

Acronym: ECCO

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2020
First posted: Apr 11, 2018
Registry last updated: Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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