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

NCT02635815 | Completed DMC

• 1 other identifier: 699
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• The presence or absence of variceal bleeding within one year of follow up.

  1 year

Study Arms (2)

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

Group II

thirty four patients without bleeding. All underwent upper gastrointestinal endoscopy.

Procedure: Upper gastrointestinal endoscopy

Interventions

Upper gastrointestinal endoscopy PROCEDURE

Upper gastrointestinal endoscopy using the Pentax video endoscope EG 3440

Group I; Group II

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Egyptian patients with non-cirrhotic portal hypertension (NCPH) with oesophageal varices, presenting with or without variceal bleeding

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

MeSH Terms

Conditions

Hypertension, Portal

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Reda Elwakil, Professor

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 17, 2015
• First Posted: December 21, 2015
• Study Start: January 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 4, 2016

Record last verified: 2016-03