NCT03269877

Brief Summary

The spleen could be considered a neglected organ. To date, it has been deemed an ancillary organ in portal hypertension or an organ localization in lymphoproliferative diseases. Hypersplenism is a common disorder characterized by an enlarged spleen which causes rapid and premature destruction of blood cells. It can result from any splenomegaly. It is most common with splenomegaly secondary to portal hypertension and hematological disorders. Portal Hypertension is an important cause of splenomegaly in most tropical countries This work will involve a series of studies aiming to:

  1. 1.Assess the prevalence and pattern of hypersplenism, and grade the severity of cytopenias in patients with cirrhosis and portal hypertension.
  2. 2.Elucidate the relationship between hypersplenism, in these patients, and:
  3. 3.The severity of liver cirrhosis as assessed by Child's and the Model of End-stage Liver Disease (MELD) scores.
  4. 4.The presence and grade of gastroesophageal varices as assessed by upper endoscopy.
  5. 5.The presence of hepatocellular carcinoma
  6. 6.Portal hemodynamics and portal vein thrombosis as assessed by Doppler Ultrasound.
  7. 7.Test the hypothesis that leucopenia in cirrhotic patients may be caused, at least in part, by apoptosis of polymorphnuclear leucocytes.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

September 1, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

August 28, 2017

Last Update Submit

August 30, 2017

Conditions

Hypersplenism

Outcome Measures

Primary Outcomes (2)

  • Prevalence

    Percentage of hypersplenism in patients proven to have liver cirrhosis and portal hypertension

    6 months

  • Severity

    Depending mainly on the severity of cytopenia of the blood elements (RBCs, WBCs, and platlets), hypersplenism will be graded as mild, moderate, or severe, and given a total score of \<2 points, 2-3 points, and \>3 points, respectively

    1 year

Secondary Outcomes (3)

  • Correlations with severity of liver disease

    1 year

  • Correlation with Eosophageal varices

    1 year

  • Correlations with hepatocellular carcinoma

    1 year

Study Arms (1)

Liver cirrhosis and hypersplenism

Patients proven to have Liver Cirrhosis and Hypersplenism based on clinical examination, Laboratory findings, and abdominal ultrasound examinaton

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All admitted patients who fulfill the inclusion criteria over a period of one year will be included. We are expecting that a total of 400 patients will be recruited.

You may qualify if:

  • All patients with documented evidence of liver cirrhosis (of any etiology other than alcoholic cirrhosis) and portal hypertension, based on clinical examination, abdominal ultrasound examination, upper gastrointestinal endoscopy.
  • Male and female patients aged between 18-60 years.

You may not qualify if:

  • Patients with splenomegaly of any cause other than liver cirrhosis.
  • Patients with any lymphoproliferative disorders.
  • Patients with extrahepatic malignancy.
  • Patients younger than 18 years old.
  • Any associated cardiovascular disease.
  • Failure to obtain consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Kim G, Cho YZ, Baik SK, Kim MY, Hong WK, Kwon SO. The accuracy of ultrasonography for the evaluation of portal hypertension in patients with cirrhosis: a systematic review. Korean J Radiol. 2015 Mar-Apr;16(2):314-24. doi: 10.3348/kjr.2015.16.2.314. Epub 2015 Feb 27.

    PMID: 25741193RESULT

  • Lv Y, Lau WY, Li Y, Deng J, Han X, Gong X, Liu N, Wu H. Hypersplenism: History and current status. Exp Ther Med. 2016 Oct;12(4):2377-2382. doi: 10.3892/etm.2016.3683. Epub 2016 Sep 7.

    PMID: 27703501RESULT

  • McCormick PA, Walker S, Benepal R. Hypersplenism is related to age of onset of liver disease. Ir J Med Sci. 2007 Dec;176(4):293-6. doi: 10.1007/s11845-007-0089-8. Epub 2007 Oct 18.

    PMID: 17943410RESULT

  • Orlando R, Lirussi F, Basso SM, Lumachi F. Splenomegaly as risk factor of liver cirrhosis. A retrospective cohort study of 2,525 patients who underwent laparoscopy. In Vivo. 2011 Nov-Dec;25(6):1009-12.

    PMID: 22021698RESULT

  • Ramirez MJ, Titos E, Claria J, Navasa M, Fernandez J, Rodes J. Increased apoptosis dependent on caspase-3 activity in polymorphonuclear leukocytes from patients with cirrhosis and ascites. J Hepatol. 2004 Jul;41(1):44-8. doi: 10.1016/j.jhep.2004.03.011.

    PMID: 15246206RESULT

MeSH Terms

Conditions

Hypersplenism

Condition Hierarchy (Ancestors)

Splenic DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Ramy M Elbarody, MSc

CONTACT

00201006486228ramybarody@yahoo.com

Ahmed H Salem, PhD

CONTACT

00201066339195ahsalem10@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator at Tropical Medicine and Gastroenterology Department

Study Record Dates

First Submitted

August 28, 2017

First Posted

September 1, 2017

Study Start

September 1, 2017

Primary Completion

October 1, 2018

Study Completion

December 31, 2018

Last Updated

September 1, 2017

Record last verified: 2017-08