Predictive Factors and Outcome of Esophageal Ulcers After Endoscopic Treatment of Esophageal Varices

October 2, 2014 updated by: Ibrahim Shebl, Tanta University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

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.

The study include more than 224 patients who undergo endoscopic management of esophageal varices:

Methods:

All patients will be subjected to:

  • full history taking.
  • -complete clinical examination.
  • -investigations for all groups: i) Complete Blood Count (CBC) ii) liver function tests iii) Kidney function tests. iv) ultrasound on abdomen and pelvis
  • Upper endoscopy at day 0 , follow up endoscopy at day 14 and at 6months

End points:

  1. ry end point:at 14 days to look for and characterize ulcer if any
  2. ry end point: at 6months to look for general and local outcome of intervention

Inclusion criteria:

Patient with esophageal varices having upper GIT endoscopy

Exclusion criteria:

Patients having endoscopy with no esophageal varices (EVs)

ETHICAL CONSIDERATIONS Unexpected risks during the course of the research will be cleared to the participants and the ethical committee on time , thrombophlebitis may occur during taking blood sample, the investigators will use sterilized techniques during taking sample also bleeding from pinpoint needle track could happen , the investigators will do needle track ablation to avoid it. The investigators will use sterilized techniques during taking sample.

Informed consent will be taken and everyone will be given a coded number . Names will not be mentioned ,no pictures will be taken to any part of the body. Results of investigations will be collected, tabulated and statistically analyzed for scientific purposes only.

Study Type

Interventional

Enrollment (Anticipated)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Gharbia
      • Tanta, Gharbia, Egypt, 31111
        • Recruiting
        • Tanta University Hospital
        • Contact:
        • Principal Investigator:
          • Asem A Elfert, MD
        • Sub-Investigator:
          • Fat-heya E Assel, MD
        • Sub-Investigator:
          • Ferial Elkalla, MD
        • Sub-Investigator:
          • Galal Elkassas, MD
        • Sub-Investigator:
          • Mohamed Elhendawy
        • Sub-Investigator:
          • Loai Mansour
        • Sub-Investigator:
          • Mohamed Rabei
        • Sub-Investigator:
          • Samah Mosaad
        • Sub-Investigator:
          • Ibrahim Kabbash, MD
        • Sub-Investigator:
          • Mohamed Elkassas
        • Sub-Investigator:
          • Islam S Ismail
        • Sub-Investigator:
          • Ibrahim Shebl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with esophageal varices having upper GIT endoscopy

Exclusion Criteria:

  • Patients having endoscopy with no EVs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Esophagogastroduodenoscope
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.
Device: Esophagogastroduodenoscope
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.
Other Names:
  • EGD, upper GI endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of esophageal ulcer bleeding after endoscopic management of esophageal varices.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Investigators

  • Principal Investigator: Asem A Elfert, MD, Tanta Faculty of Medicine, Professor
  • Study Director: Fat-heya E Assel, MD', Tanta Faculty of Medicine, Professor
  • Study Director: Ferial Elkalla, MD, Tanta Faculty of Medicine, Professor
  • Study Director: Galal Elkassas, MD, Tanta Faculty of Medicine, Professor
  • Study Director: Mohamed Elhendawy, Dr.
  • Study Director: Loai Mansour, Dr.
  • Study Director: Mohamed Rabei, Dr.
  • Study Director: Samah Mosaad, Dr.
  • Study Director: Ibrahim A Kabbash, MD, Tanta Faculty of Medicine, Professor
  • Study Director: Mohamed Elkassas, Dr.
  • Study Director: Islam S Ismail, Dr.
  • Study Director: Ibrahim Shebl, Dr.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

September 26, 2014

First Submitted That Met QC Criteria

September 30, 2014

First Posted (Estimate)

October 3, 2014

Study Record Updates

Last Update Posted (Estimate)

October 6, 2014

Last Update Submitted That Met QC Criteria

October 2, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • esophageal ulcers

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ulcer

Clinical Trials on Esophagogastroduodenoscope

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe