The Role of Endoscopic Ultrasound in Evaluation of Patients With Indefinite Cause of Bile Duct Dilatation

Bile Duct Diseases Clinical Trial

Official title:

Assistant Lecturer of Tropical Medicine and Gastroenterology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05475964
• Other study ID #: EUS in biliary dilatation
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 9, 2022
• Est. completion date: August 2025

Study information

• Verified date: July 2022
• Source: Assiut University
• Contact: hager Hamed, Master
• Phone: 01090377530
• Email: hagerhamed1992[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In the era of diagnostic imaging advances, Bile Duct Dilatation becomes a common incidental finding in patients present with either gastrointestinal symptoms or undergone the imaging study for any other complaints. Endoscopic ultrasound enables high resolution views of the biliary system, so it can help detection of different pathologies which cause bile duct dilatation and difficult to be detected by other imaging studies.

Description:

The normal diameter of the common bile duct (CBD) varies by age, imaging modality, prior cholecystectomy, and previous biliary obstruction, but 7 mm or more is considered widely accepted cutoff for biliary dilatation, and 10 mm or more among post-cholecystectomy patients.

BDD with unclear etiology detected on trans abdominal ultrasound (TUS), computed tomography (CT), or magnetic resonance cholangiopancreatography (MRCP). Although, these imaging techniques have a good sensitivity and specificity in detecting biliary tract diseases, limitations are still present in the detection of intraductal small stones, ampullary lesions and small masses.

As regard TUS, overlying bowel gas and operator-dependence, often harshen an adequate visualization of the biliary duct to identify the etiology, and CT could miss tumors less than 2 cm in size, while the sensitivity of MRCP decreases in stones 3 mm or less in size.

Endoscopic ultrasound (EUS) enables high resolution views of the biliary tree as it joins the pancreatic duct and duodenum, so it helps detection of biliary pathologies difficult to be diagnosed by external radiograph. In addition, EUS is less invasive than the competitive endoscopic retrograde cholangiopancreatography (ERCP) as a diagnostic modality and it avoids the patients the post-ERCP pancreatitis which is a very common complication, as well as providing a unique opportunity of tissue sampling and staging of any detected malignant lesions.

Previously, EUS has proven it's high ability to the detect the stones in the extrahepatic ducts with a sensitivity as high as of 94% and specificity of 95%.

Besides, it's well performance in the evaluation of biliary strictures with a sensitivity 80%, and a specificity of 97% in detecting malignant biliary strictures.

When it comes to ampullary and pancreatic lesions, direct endoscopic visualization with a side-viewing endoscope can effectively evaluate the periampullary area and detect ampullary mass and diverticulum, as well examine the pancreas for chronic pancreatitis, masses, and cysts.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Prior inconclusive imaging studies of bile duct dilation.

2. Common bile duct diameter of >10 mm with prior cholecystectomy or >7 mm without

Exclusion Criteria:

Definite cause of obstruction stone, stricture, or mass on imaging studies (TUS, CT, MRCP or ERCP).

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Related Conditions & MeSH terms

• Bile Duct Diseases

Intervention

Device:
• Endoscopic ultrasound
Endoscopic ultrasound and biopsy intake of suspected lesions

Locations

Country	Name	City	State
Egypt	AssiutU	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
HMHamed

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients with bile duct dilatation	Can EUS detect the cause of bile duct dilatation in patients not diagnosed by other imaging modalities	2 years