Extrahepatic CholestasisNCT03237247
Role of Complete Blood Picture in Predicting the Etiology of Extrahepatic Cholestasis
An observational study of Extrahepatic Cholestasis, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Extrahepatic Cholestasis
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 28 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Child, Adult, Older adult
Study population: patients with extrahepatic cholestasis
Who may be able to join
- patients with extrahepatic cholestasis
Who cannot join
- age under 14 years
- previous bilio-pancreatic interventions
- hemoglobinopathy
- splenomegaly
- myeloproliferative disorders
- diabetes mellitus
- recent blood transfusion in less than one month
About this study
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.
- Conditions
- Extrahepatic Cholestasis
- Keywords
- extrahepatic cholestasis, CBC
- Medical subject headings
- Cholestasis, Extrahepatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
differential diagnosis of extrahepatic cholestasis
complete blood count parameters
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start1 Mar 2016
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extrahepatic CholestasisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael M Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237247
- Sponsor's protocol ID
- 17100256
- Status last verified
- Aug 2017
- First submitted
- 22 Jul 2017
- Last updated
- 8 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Complete Blood Picture in Predicting the Etiology of Extrahepatic Cholestasis
- ClinicalTrials.gov ID
- NCT03237247
- Acronym / sponsor ID
- 17100256
- Conditions
- Extrahepatic Cholestasis
- Keywords
- extrahepatic cholestasis, CBC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 2 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients with extrahepatic cholestasis
Key inclusion criteria (1 listed)
- patients with extrahepatic cholestasis
Key exclusion criteria (7 listed)
- age under 14 years
- previous bilio-pancreatic interventions
- hemoglobinopathy
- splenomegaly
- myeloproliferative disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
differential diagnosis of extrahepatic cholestasis
Time frame: 10 days
complete blood count parameters
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Extrahepatic Cholestasis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differential diagnosis of extrahepatic cholestasis (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2017.