NCT05475964

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 9, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

July 27, 2022

Status Verified

July 1, 2022

Enrollment Period

2.2 years

First QC Date

July 20, 2022

Last Update Submit

July 26, 2022

Conditions

Bile Duct Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

patients with undiagnosed bile duct dilatation

OTHER

patients with bile duct dilation detected by imaging studies without revealing definite cause of obstruction

Device: Endoscopic ultrasound

Interventions

Endoscopic ultrasoundDEVICE

Endoscopic ultrasound and biopsy intake of suspected lesions

patients with undiagnosed bile duct dilatation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prior inconclusive imaging studies of bile duct dilation.
  • Common bile duct diameter of \>10 mm with prior cholecystectomy or \>7 mm without

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AssiutU

Asyut, Egypt

Location

MeSH Terms

Conditions

Bile Duct Diseases

Interventions

Endosonography

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Hager Hamed, Master

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hager Hamed, Master

CONTACT

01090377530hagerhamed1992@med.aun.edu.eg

Hamed

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant lecturer of tropical medicine and gastroenterology

Study Record Dates

First Submitted

July 20, 2022

First Posted

July 27, 2022

Study Start

September 9, 2022

Primary Completion

December 1, 2024

Study Completion

August 1, 2025

Last Updated

July 27, 2022

Record last verified: 2022-07

Locations

EG(1)