Liver CirrhosisNCT03269786
Changes in Lab and Ultrasonography After Endoscopic Varisceal Treatment
An observational study of Liver Cirrhosis, run by Assiut University at 1 site in Egypt.
Trial summary
laboratory and ultrasongraphicc changes after endoscopical varices treatment Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Liver function tests (ALT,AST,ALBUMIN,BILIRUBIN,INR,PC,CBC) and biannual ultrasonography
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 1 Nov 2019
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients with liver cirrhosis and portal hyprtension with esophagel varisces
Who may be able to join
- patients with liver cirrhosis and portal hyprtension with esophagel varisces
Who cannot join
- 1. Patients with heart failure or renal failure 2. patients with COPD 3. Patients with hepato cellular carcinoma and portal vein thrombosis 4. Pregnant
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University
Asyut, 171516
Salwa elgendi, Proessor doctor, 01005766155, sawaelgendi@yahoo.com
hanan sharaf, assI stand professor, 01005035006, dr_hanansharaf@.com
About this study
Official title: Laoboratory and Ultrasonographic Changes After Endoscopic Varisceal Treatment
laboratory and ultrasongraphicc changes after endoscopical varices treatment
- Conditions
- Liver Cirrhosis
- Being tested
- Liver function tests (ALT,AST,ALBUMIN,BILIRUBIN,INR,PC,CBC), biannual ultrasonography
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver function tests (ALT,AST,ALBUMIN,BILIRUBIN,INR,PC,CBC)Diagnostic test
Liver function tests will be assessed after endoscopic varisceal treatment for 6 monthes
biannual ultrasonographyDevice
portal vein diameter , portal vein velocity and flow direction, volume flow in portal vein , congetive index, spleen size.will be assessed after endoscopic varisceal treatment by using biannual ultrasonography for 6 monthes
| Study group | Role | What they receive |
|---|---|---|
| cirrhotic patients with esophagel varisces | Endoscopic band ligation or injection scelerotheraby will be done for all patients Receives: Diagnostic Test: Liver function tests (ALT,AST,ALBUMIN,BILIRUBIN,INR,PC,CBC); Device: biannual ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in liver function tests
Liver function tests (ALT, AST, bilirubin,Albumin,Cbc,Prothrombin time,INR ) level (expected to be lower after endoscopic varisceal treatment
(ex
Measured: 6 months
Ultrasonographic changes
{ portal vein diameter , portal vein velocity and flow direction, volume flow in portal vein , congetive index, spleen size.(expected to be chnged after endoscopic varisceal treatment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Nov 2018 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdelhamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269786
- Sponsor's protocol ID
- laucaevt
- Status last verified
- Oct 2018
- First submitted
- 27 Aug 2017
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laoboratory and Ultrasonographic Changes After Endoscopic Varisceal Treatment
- ClinicalTrials.gov ID
- NCT03269786
- Acronym / sponsor ID
- laucaevt
- Conditions
- Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 1 Sep 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.
laboratory and ultrasongraphicc changes after endoscopical varices treatment
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cirrhotic patients with esophagel varisces | – | Diagnostic Test: Liver function tests (ALT,AST,ALBUMIN,BILIRUBIN,INR,PC,CBC), Device: biannual ultrasonographyEndoscopic band ligation or injection scelerotheraby will be done for all patients |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients with liver cirrhosis and portal hyprtension with esophagel varisces
Key inclusion criteria (1 listed)
- patients with liver cirrhosis and portal hyprtension with esophagel varisces
Key exclusion criteria (1 listed)
- 1. Patients with heart failure or renal failure 2. patients with COPD 3. Patients with hepato cellular carcinoma and portal vein thrombosis 4. Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver function tests (ALT,AST,ALBUMIN,BILIRUBIN,INR,PC,CBC)Liver function tests will be assessed after endoscopic varisceal treatment for 6 monthes | Diagnostic test | cirrhotic patients with esophagel varisces |
| biannual ultrasonographyportal vein diameter , portal vein velocity and flow direction, volume flow in portal vein , congetive index, spleen size.will be assessed after endoscopic varisceal treatment by using biannual ultrasonography for 6 monthes | Device | cirrhotic patients with esophagel varisces |
Primary outcome
Changes in liver function tests
Time frame: 6 months
Liver function tests (ALT, AST, bilirubin,Albumin,Cbc,Prothrombin time,INR ) level (expected to be lower after endoscopic varisceal treatment (ex
Ultrasonographic changes
Time frame: 6 months
{ portal vein diameter , portal vein velocity and flow direction, volume flow in portal vein , congetive index, spleen size.(expected to be chnged after endoscopic varisceal treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by Assiut University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact salwa el gendi, professor doctor (01005766155, salwaelgendi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in liver function tests (time frame: 6 months). The study lists 2 primary outcomes in all. 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 9 Oct 2018.