NCT03237247

Brief Summary

Cases with extrahepatic cholestasis are common and faced during day to day clinical practice, however reaching the final etiology is sometimes challenging and needs investigations which are usually expensive, may carry hazards to the patients, or inaccessible so we are in need for a method which is easily available, affordable and safe for aiding in the differential diagnosis of extrahepatic cholestasis. our study aiming to evaluate the role of complete blood count in predicting the etiology of extrahepatic cholestasis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Shorter than P25 for all trials

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

March 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

12 months

First QC Date

July 22, 2017

Last Update Submit

August 7, 2017

Conditions

Extrahepatic Cholestasis

Keywords

extrahepatic cholestasis, CBC

Outcome Measures

Primary Outcomes (1)

  • differential diagnosis of extrahepatic cholestasis

    complete blood count parameters

    10 days

Study Arms (5)

Benign

cases with benign biliary stricture

Calcular OJ

cases with calcular extrahepatic cholestasis

Malignant Distal

cases with malignant distal extrahepatic cholestasis

Malignant Proximal

cases with malignant proximal extrahepatic cholestasis

Intrahepatic

cases with intrahepatic cholestasis

Eligibility Criteria

Age14 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with extrahepatic cholestasis

You may qualify if:

  • patients with extrahepatic cholestasis

You may not qualify if:

  • age under 14 years
  • previous bilio-pancreatic interventions
  • hemoglobinopathy
  • splenomegaly
  • myeloproliferative disorders
  • diabetes mellitus
  • recent blood transfusion in less than one month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cholestasis, Extrahepatic

Condition Hierarchy (Ancestors)

CholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

July 22, 2017

First Posted

August 2, 2017

Study Start

March 1, 2016

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

August 8, 2017

Record last verified: 2017-08