NCT04112030

Brief Summary

The study aimed to assess role of DIA in diagnosing nature of indeterminate bile ducts stricture

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2016

Status
completed

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

Study Start

First participant enrolled

October 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
Last Updated

October 2, 2019

Status Verified

September 1, 2019

Enrollment Period

1.4 years

First QC Date

September 30, 2019

Last Update Submit

September 30, 2019

Conditions

Bile Duct Stricture

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of DIA compared to routine cytology in case of IBDS

    all samples were subjected to DIA and routine cytology and the result was compared with final diagnosis

    Baseline

Interventions

Digital image analysisDIAGNOSTIC_TEST

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

the study included 50 patients with biliary stricture with no obvious cause in MRCP

You may qualify if:

  • Any patient presented with biliary stricture with no obvious cause in abdominal imaging

You may not qualify if:

  • biliary obstruction due to other causes as stones, or tumor,
  • biliary surgery within the last six months
  • Coagulopathy
  • lost follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Park JY, Jeon TJ. Factors Associated with Malignant Biliary Strictures in Patients with Atypical or Suspicious Cells on Brush Cytology. Clin Endosc. 2019 Mar;52(2):168-174. doi: 10.5946/ce.2018.105. Epub 2019 Jan 9.

    PMID: 30625267BACKGROUND

  • Aljahdli ES. Management of distal malignant biliary obstruction. Saudi J Gastroenterol. 2018 Mar-Apr;24(2):71-72. doi: 10.4103/sjg.SJG_611_17. No abstract available.

    PMID: 29637911BACKGROUND

  • Helmy A, Saad Eldien HM, Seifeldein GS, Abu-Elfatth AM, Mohammed AA. Digital Image Analysis has an Additive Beneficial Role to Conventional Cytology in Diagnosing the Nature of Biliary Ducts Stricture. J Clin Exp Hepatol. 2021 Mar-Apr;11(2):209-218. doi: 10.1016/j.jceh.2020.07.009. Epub 2020 Jul 26.

    PMID: 33746446DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Biliary brush sample were subjected to routine cytology and digital image analysis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Al-rahji University Hospital, Faculty of Medicine, Assiut, Egypt

Study Record Dates

First Submitted

September 30, 2019

First Posted

October 2, 2019

Study Start

October 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

October 2, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share