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

Assistant Lecturer of Tropical Medicine and Gastroenterology

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05475964
Enrollment
50
Registered
2022-07-27
Start date
2022-09-09
Completion date
2025-08-31
Last updated
2022-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile Duct Diseases

Brief 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.

Detailed 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.

Interventions

DEVICEEndoscopic ultrasound

Endoscopic ultrasound and biopsy intake of suspected lesions

Sponsors

HMHamed
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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). \-

Design outcomes

Primary

MeasureTime frameDescription
The percentage of patients with bile duct dilatation2 yearsCan EUS detect the cause of bile duct dilatation in patients not diagnosed by other imaging modalities

Countries

Egypt

Contacts

Primary Contacthager Hamed, Master
hagerhamed1992@med.aun.edu.eg01090377530
Backup ContactHamed

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026