EUS Evaluation of CBD Diameter in Malignant Obstructive Jaundice

NCT03494023 | Completed

• 1 other identifier: Col-gastro 7
• Study Type: observational
• Target: 539
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Common bile duct diameter

  Measurement by endoscopic ultrasound in patients with malignant obstructive jaundice

  Enrollment over 6 months

Interventions

Endoscopic ultrasound DIAGNOSTIC_TEST

Measurement of the common bile duct diameter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinical Hospital Colentina: lead
• Catholic University, Italy: collaborator

Study Sites (1)

Gastroenterology Department, Clinical Hospital Colentina

Bucharest, 020125, Romania

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Jaundice, Obstructive

Interventions

Endosonography

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Jaundice; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mihai Rimbas, MD, PhD

  Clinical Hospital Colentina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 31, 2018
• First Posted: April 11, 2018
• Study Start: March 27, 2018
• Primary Completion: December 31, 2019
• Study Completion: April 15, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)