ClinicalTrials.gg
CompletedNCT03237247Updated Aug 8, 2017

Role of Complete Blood Picture in Predicting the Etiology of Extrahepatic Cholestasis

An observational study in Extrahepatic Cholestasis, sponsored by Assiut University. Completed. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2017-08-08.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
38
Ages
14 Years and older
Sex
All
01

Study 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.

Read the detailed description

Extrahepatic cholestasis has various etiologies including benign causes (benign stricture, chronic pancreatitis, choledochal cyst, mirizzi syndrome, etc...), choledocholithiasis, malignant causes (cancer pancreas, gallbladder cancer, cholangiocarcinoma, etc....), parasitic infestations (fasciola hepatica, ascaris lumbricoides, etc......) and other causes. it is essential to detect the exact cause of extrahepatic cholestasis in order to determine treatment options. diagnosing such conditions depends on clinical examination, laboratory investigations, imaging studies, endoscopic procedures, biopsy and even surgical intervention. some of these investigations are expensive, not available, or carry risk to the patients. moreover non of them is accurate 100%. Complete blood count is already available, easy to obtain, not invasive investigation. In these study we are trying to evaluate the role of complete blood count parameters namely RDW, MPV, PDW, PCT, NLR, PLR in the differential diagnosis of extrahepatic cholestasis.

02

Conditions studied

  • Extrahepatic Cholestasis

Keywords

  • extrahepatic cholestasis, CBC
03

In context

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

patients with extrahepatic cholestasis

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with extrahepatic cholestasis

Exclusion criteria

Exclusion Criteria:

  • age under 14 years
  • previous bilio-pancreatic interventions
  • hemoglobinopathy
  • splenomegaly
  • myeloproliferative disorders
  • diabetes mellitus
  • recent blood transfusion in less than one month
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
38 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. differential diagnosis of extrahepatic cholestasis

    complete blood count parameters

    Time frame: 10 days

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2016 to primary completion in Feb 2017, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2017
First posted
Aug 2, 2017
StartActual
Mar 1, 2016
Primary completionActual
Feb 28, 2017
CompletionActual
Feb 28, 2017
Last update
Aug 8, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03237247
Lead sponsor
Assiut University
Responsible party
Wael M Sayed (principle investigator, Assiut University) — Principal investigator
First posted
Aug 2, 2017
Start date
Mar 1, 2016
Primary completion
Feb 28, 2017
Completion
Feb 28, 2017
Last update
Aug 8, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion