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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03237247
Recruitment Status : Completed
First Posted : August 2, 2017
Last Update Posted : August 8, 2017
Sponsor:
Information provided by (Responsible Party):
Wael M Sayed, Assiut University

Tracking Information
First Submitted Date July 22, 2017
First Posted Date August 2, 2017
Last Update Posted Date August 8, 2017
Actual Study Start Date March 1, 2016
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 7, 2017)
differential diagnosis of extrahepatic cholestasis [ Time Frame: 10 days ]
complete blood count parameters
Original Primary Outcome Measures
 (submitted: July 30, 2017)
differential diagnosis extrahepatic cholestasis [ Time Frame: 10 days ]
complete blood count parameters
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Role of Complete Blood Picture in Predicting the Etiology of Extrahepatic Cholestasis
Official Title Role of Complete Blood Picture in Predicting the Etiology of Extrahepatic Cholestasis
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population patients with extrahepatic cholestasis
Condition Extrahepatic Cholestasis
Intervention Not Provided
Study Groups/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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 30, 2017)
38
Original Actual Enrollment Same as current
Actual Study Completion Date February 28, 2017
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03237247
Other Study ID Numbers 17100256
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wael M Sayed, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date August 2017