EUS Evaluation of CBD Diameter in Malignant Obstructive Jaundice

Pancreatic Cancer Clinical Trial

— ECCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03494023
• Other study ID #: Col-gastro 7
• Status: Completed
• Start date: March 27, 2018
• Est. completion date: April 15, 2020

Study information

• Verified date: April 2020
• Source: Clinical Hospital Colentina
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 539
• Est. completion date: April 15, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ampulla of Vater Cancer
• Cholangiocarcinoma
• Cholangiocarcinoma of the Extrahepatic Bile Duct
• Jaundice
• Jaundice, Obstructive
• Pancreatic Cancer

Intervention

Diagnostic Test:
• Endoscopic ultrasound
Measurement of the common bile duct diameter

Locations

Country	Name	City	State
Romania	Gastroenterology Department, Clinical Hospital Colentina	Bucharest

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Hospital Colentina	Catholic University, Italy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Common bile duct diameter	Measurement by endoscopic ultrasound in patients with malignant obstructive jaundice	Enrollment over 6 months