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Clinical Trials/NCT02256046
NCT02256046UnknownNot Applicable

Predictive Factors and Outcome of Esophageal Ulcers After Endoscopic Treatment of Esophageal Varices; Multicenter Study

Tanta University2 sites in 1 country224 target enrollmentStarted: August 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
224
Locations
2
Primary Endpoint
Incidence of esophageal ulcer bleeding after endoscopic management of esophageal varices.

Study Overview

Brief Summary

Aim of this thesis is to predict the incidence of esophageal ulcer bleeding after endoscopic management of esophageal varices.

This study will be in the department of Tropical Medicine and Infectious Diseases, Tanta University, in at least six months in the period from august 2014 to march 2015 or until the target number of patients reached whichever is longer.

Detailed Description

Portal hypertension is a common clinical syndrome, defined by a pathologic increase in the portal venous pressure, in which the hepatic venous pressure gradient (HVPG) is increased above normal values (1-5 mmHg). In cirrhosis, portal hypertension results from the combination of increased intrahepatic vascular resistance and increased blood flow through the portal venous system.

Esophageal variceal bleeding is one of the most serious complications of portal hypertension, and represents a leading cause of death in patients with cirrhosis. Each bleeding episode is associated with a 30% mortality rate.

Endoscopic therapies for varices aim to reduce variceal wall tension by obliteration of the varix. The two principal methods available for esophageal varices are endoscopic sclerotherapy (EST) and band ligation (EBL). Endoscopic therapy is a local treatment that has no effect on the pathophysiological mechanisms that lead to portal hypertension and variceal rupture. However, a spontaneous decrease in HVPG occurs in around 30% of patients treated with either EST or EBL to prevent variceal rebleeding. EST consists of the injection of a sclerosing agent into the variceal lumen or adjacent to the varix, with flexible catheter with a needle tip, inducing thrombosis of the vessel and inflammation of the surrounding tissues. During active bleeding, sclerotherapy may achieve hemostasis, inducing variceal thrombosis and external compression by tissue edema. With repeated sessions, the inflammation of the vascular wall and surrounding tissues leads to fibrosis, resulting in variceal obliteration.

Furthermore, vascular thrombosis may induce ulcers that also heal, inducing fibrosis. There are technical variations in performing EST, such as type and concentration of the sclerosants, volume injected, interval between sessions, and number of sessions Endoscopic band ligation (EBL) is generally accepted as the treatment of choice for bleeding from esophageal varices. It has shown good results in terms of the control of the active bleeding, with few untoward effects.

Esophageal ulcerations ulcerations occur in the esophageal mucosa after all successful ligations. However, ulcers following Esophageal Variceal Ligation (EVL) are less severe than with ES.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient with esophageal varices having upper GIT endoscopy

Exclusion Criteria

  • Patients having endoscopy with no EVs

Outcomes

Primary Outcomes

Incidence of esophageal ulcer bleeding after endoscopic management of esophageal varices.

Time Frame: 6 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ibrahim Shebl

Dr.

Tanta University

Study Sites (2)

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