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Risk Factors for Variceal Bleeding in Egyptian Patients With Non-Cirrhotic Portal Hypertension

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: NCT02635815
Recruitment Status : Completed
First Posted : December 21, 2015
Last Update Posted : March 4, 2016
Sponsor:
Information provided by (Responsible Party):
Sara Abdelhakam, Ain Shams University

Brief Summary:

Background & Aims: Non-cirrhotic portal hypertension (NCPH) represents a relatively infrequent group of conditions. This work aimed at determining causes of NCPH and evaluating the role of some clinical, laboratory, imaging and endoscopic parameters in prediction of variceal bleeding in an Egyptian cohort with NCPH.

Methods: Sixty patients with non-cirrhotic portal hypertension and oesophageal varices were included. All underwent complete clinical evaluation, laboratory investigations, Color Doppler ultrasonography, platelet count/spleen diameter (mm) ratio and upper gastrointestinal endoscopy. Patients were classified into two groups according to variceal bleeding: (1) Group I: twenty six patients with history of bleeding or had an attack of bleeding during one year follow-up; and (2) Group II: thirty four patients without bleeding.


Condition or disease Intervention/treatment
Portal Hypertension Procedure: Upper gastrointestinal endoscopy

Detailed Description:
All of the included patients underwent: (1) A complete clinical evaluation; (2) Laboratory investigations: CBC, liver profile, viral markers (HBs Ag, HB core Ab, HCV Ab) using the ELISA technique; (3) Thrombophilia workup to clarify the underlying etiology of vascular liver disease. It was done only for patients with Budd-Chiari syndrome and extrahepatic portal vein thrombosis: anticardiolipin antibodies, lupus anticoagulant, antinuclear antibodies, protein C, S, antithrombin III, factor V Leiden G1691A mutation, prothrombin gene G20210A mutation, methylene tetrahydrofolate reductase C677T mutation by PCR, Janus tyrosine kinase-2 (JAK II) V617F mutation by PCR (to exclude myeloproliferative disorders) and flow cytometry for CD55 and CD59 (to exclude paroxysmal nocturnal hemoglobinuria); (4) Abdominal ultrasonography: for liver size, echogenicity, spleen size, portal vein diameter and ascites; (5) Color Doppler ultrasonographic study: was done in the morning after an overnight fasting using a color Doppler unit with a 3.5 MHz convex probe for confirmation of portal vein (PV) patency and diameter, mean PV flow velocity (mean PVV) (cm/sec), PV direction of flow, splenic vein patency and diameter, presence of portosystemic collaterals and patency of hepatic veins; (6) Platelet count/spleen diameter ratio: calculated as: platelet count/ maximum spleen bipolar diameter by ultrasound in mm; (7) Ultrasonography guided liver biopsy: for diagnosis of NCPH and exclusion of cirrhotic portal hypertension; and (8) Upper gastrointestinal endoscopy using the Pentax video endoscope EG 3440. Oesophageal varices were classified according to their size into small, medium or large [8]. Prophylaxis with band ligation was done to patients with large or medium sized risky varices who were eligible for starting anticoagulation. The diagnosis of variceal bleeding was confirmed if an actively bleeding varix or a varix with adherent clot or white nipple was seen. Red color signs were classified into Cherry Red Spots "CRS", Red Wale Markings "RWM" and Hematocystic Spots "HCS". Gastric varices were classified into either gastro-esophageal varices (GEV) or isolated gastric varices (IGV). Portal hypertensive gastropathy (PHG) was classified into either mild or severe.

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Variceal Bleeding in Egyptian Patients With Non-Cirrhotic Portal Hypertension
Study Start Date : January 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Endoscopy

Group/Cohort Intervention/treatment
Group I
twenty six patients with history of bleeding or had an attack of bleeding during one year follow-up. All underwent upper gastrointestinal endoscopy.
Procedure: Upper gastrointestinal endoscopy
Upper gastrointestinal endoscopy using the Pentax video endoscope EG 3440

Group II
thirty four patients without bleeding. All underwent upper gastrointestinal endoscopy.
Procedure: Upper gastrointestinal endoscopy
Upper gastrointestinal endoscopy using the Pentax video endoscope EG 3440




Primary Outcome Measures :
  1. The presence or absence of variceal bleeding within one year of follow up. [ Time Frame: 1 year ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Egyptian patients with non-cirrhotic portal hypertension (NCPH) with oesophageal varices, presenting with or without variceal bleeding
Criteria

Inclusion Criteria:

  • Egyptian patients with non-cirrhotic portal hypertension (NCPH) with oesophageal varices

Exclusion Criteria:

  • Patients with concomitant infection with viral hepatitis, cirrhotic portal hypertension, hepatocellular carcinoma as well as those with other sources of bleeding such as erosions or ulcers were excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635815


Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Reda Elwakil, Professor Ain Shams University

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Responsible Party: Sara Abdelhakam, Assistant Professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT02635815    
Other Study ID Numbers: 699
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Hypertension, Portal
Hypertension
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases