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Status unknownNCT03269786Updated Oct 9, 2018

Changes in Lab and Ultrasonography After Endoscopic Varisceal Treatment

An observational study in Liver Cirrhosis, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 60 Years
Sex
All
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Study summary

laboratory and ultrasongraphicc changes after endoscopical varices treatment

02

Conditions studied

  • Liver Cirrhosis

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03

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

patients with liver cirrhosis and portal hyprtension with esophagel varisces

Inclusion criteria

  • patients with liver cirrhosis and portal hyprtension with esophagel varisces

Exclusion criteria

Exclusion Criteria:

    1. Patients with heart failure or renal failure 2. patients with COPD 3. Patients with hepato cellular carcinoma and portal vein thrombosis 4. Pregnant
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • cirrhotic patients with esophagel varisces

    Endoscopic band ligation or injection scelerotheraby will be done for all patients

    Diagnostic Test: Liver function tests (ALT,AST,ALBUMIN,BILIRUBIN,INR,PC,CBC) · Device: biannual ultrasonography

Interventions

  • Diagnostic testLiver function tests (ALT,AST,ALBUMIN,BILIRUBIN,INR,PC,CBC)

    Liver function tests will be assessed after endoscopic varisceal treatment for 6 monthes

  • Devicebiannual ultrasonography

    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

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6 months

  2. 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

    Time frame: 6 months

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Study locations

1 site
  • Assiut University
    Assuit, 171516, Egypt
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03269786
Lead sponsor
Assiut University
Responsible party
Mahmoud Abdelhamed (principal investigator, Assiut University) — Principal investigator
First posted
Sep 1, 2017
Start date
Nov 1, 2018 (estimated)
Primary completion
Nov 1, 2019 (estimated)
Completion
Nov 1, 2019 (estimated)
Last update
Oct 9, 2018

Study contacts

salwa el gendi, professor doctor
Contact
salwaelgendi@yahoo.com
01005766155
hanan sharaf, assistant professor
Contact
dr_hanansharaf@yahoo.com
01005035006

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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