The Role of Endoscopic Ultrasound in Evaluation of Patients With Indefinite Cause of Bile Duct Dilatation
Primary Purpose
Bile Duct Diseases
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endoscopic ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Bile Duct Diseases
Eligibility Criteria
Inclusion Criteria:
- Prior inconclusive imaging studies of bile duct dilation.
- 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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Sites / Locations
- AssiutU
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patients with undiagnosed bile duct dilatation
Arm Description
patients with bile duct dilation detected by imaging studies without revealing definite cause of obstruction
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05475964
Brief Title
The Role of Endoscopic Ultrasound in Evaluation of Patients With Indefinite Cause of Bile Duct Dilatation
Official Title
Assistant Lecturer of Tropical Medicine and Gastroenterology
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 9, 2022 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
HMHamed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients with undiagnosed bile duct dilatation
Arm Type
Other
Arm Description
patients with bile duct dilation detected by imaging studies without revealing definite cause of obstruction
Intervention Type
Device
Intervention Name(s)
Endoscopic ultrasound
Intervention Description
Endoscopic ultrasound and biopsy intake of suspected lesions
Primary Outcome Measure Information:
Title
The percentage of patients with bile duct dilatation
Description
Can EUS detect the cause of bile duct dilatation in patients not diagnosed by other imaging modalities
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Prior inconclusive imaging studies of bile duct dilation.
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).
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hager Hamed, Master
Phone
01090377530
Email
hagerhamed1992@med.aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Hamed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hager Hamed, Master
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
AssiutU
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
The Role of Endoscopic Ultrasound in Evaluation of Patients With Indefinite Cause of Bile Duct Dilatation
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