- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03237247
Role of Complete Blood Picture in Predicting the Etiology of Extrahepatic Cholestasis
August 7, 2017 updated by: Wael M Sayed, Assiut University
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
38
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with extrahepatic cholestasis
Description
Inclusion Criteria:
- patients with extrahepatic cholestasis
Exclusion Criteria:
- age under 14 years
- previous bilio-pancreatic interventions
- hemoglobinopathy
- splenomegaly
- myeloproliferative disorders
- diabetes mellitus
- recent blood transfusion in less than one month
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
differential diagnosis of extrahepatic cholestasis
Time Frame: 10 days
|
complete blood count parameters
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2016
Primary Completion (Actual)
February 28, 2017
Study Completion (Actual)
February 28, 2017
Study Registration Dates
First Submitted
July 22, 2017
First Submitted That Met QC Criteria
July 30, 2017
First Posted (Actual)
August 2, 2017
Study Record Updates
Last Update Posted (Actual)
August 8, 2017
Last Update Submitted That Met QC Criteria
August 7, 2017
Last Verified
August 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17100256
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Extrahepatic Cholestasis
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Theresienkrankenhaus und St. Hedwig-Klinik GmbHHelios Kliniken SchwerinRecruitingExtrahepatic CholestasisGermany
-
Theresienkrankenhaus und St. Hedwig-Klinik GmbHUniversitätsmedizin MannheimCompletedBile Duct Obstruction | Extrahepatic CholestasisGermany
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Theresienkrankenhaus und St. Hedwig-Klinik GmbHCompletedBile Duct Obstruction, ExtrahepaticGermany
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Woo Hyun PaikTerminatedBiliary Stasis, ExtrahepaticKorea, Republic of
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Theresienkrankenhaus und St. Hedwig-Klinik GmbHUniversity Hospital HeidelbergRecruitingBile Duct Obstruction, ExtrahepaticGermany
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Beaujon HospitalUnknown
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Gangnam Severance HospitalRecruitingBile Duct Obstruction, ExtrahepaticKorea, Republic of
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Asan Medical CenterCompletedCholestasis, ExtrahepaticKorea, Republic of
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Boston Scientific CorporationCompletedCholestasis, ExtrahepaticUnited States
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University of Southern CaliforniaCompletedCholestasis, ExtrahepaticUnited States