Effect of Variceal Eradication on Portal Circulation

Assessment of Portal Circulation Before and After Variceal Eradication in Patients With Liver Cirrhosis.

Study the effect of variceal eradication on portal circulation, liver stiffness and Child-Pugh and MELD scores in patients with liver cirrhosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Portosystemic Collateral Veins
• Intervention / Treatment: Radiation: Abdominal computed tomography with angiography.

Detailed Description

Portosystemic collateral circulation is a consequence of portal hypertension, which occurs in chronic liver disease and is responsible for numerous complications.

Gastric and oesophageal varices are two of common portosystemic collaterals, patients usually presented with hematemesis, melena, or both, ultimately 20% is the mortality during the first attack.

Although both band ligation and sclerotherapy are effective modalities of treatment in controlling acute variceal bleeding, in preventing future variceal bleeding as well as in eradicating varices with very few complications , their effects on portal circulation have raised concerns among hepatologist.

Information about collateral pathways is especially relevant when interventional procedures or surgery is indicated because inadvertent distribution of these vessels can cause significant bleeding.

Few studies pointed on development of new portosystemic collaterals post variceal eradication depending on abdominal computed tomography (CT ) compared to pre-variceal eradication as showed paraoesophageal varices, retro-gastric varices not visualized with endoscopy ,or large deep gastric collaterals that may increase risk for rebleeding.

Also, liver stiffness measurement and indirect markers of portal hypertension have been correlated with the severity of portal hypertension and have been used to predict the presence of varices, and there is rising question what about effect of variceal eradication on liver stiffness.

The Child-Pugh and MELD scores were significantly higher for patients with gastric variceal bleeding , and the question here is variceal eradication can improve Child-Pugh and MELD scores or there is no effect.

• Study Type: Observational
• Enrollment (Anticipated): 52

Contacts and Locations

• Study Contact: Name: Esraa Swifee, M.A gastroenterology; Phone Number: +201000700150; Email: esraayousef27@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with documented liver cirrhosis (Based on clinical, laboratory and ultrasonographic findings) undergoing either primary or secondary prophylaxis variceal eradication at endoscopy unit of El-Rajhi hospital, Assuit University.

Description

Inclusion Criteria:

• • Age between 18 and 70 years old.

  • Patient with documented liver cirrhosis undergoing either primary or secondary prophylactic variceal eradication.
  • Liver cirrhosis with Child-Pugh score A and B.

Exclusion Criteria:

• • Age less than 18 years.

  • Have contraindications to computed abdominal CT-angiography (e.g. allergy to all suitable contrast agents, renal failure).
  • Patients with history of recent significant bleeding varices.
  • Previous history of variceal ligation, sclerotherapy, and TIPS operation.
  • Patients with isolated gastric varices.
  • Patients with HCC or other malignancies.
  • End-stage liver disease (Child score more than 9).
  • Patients with malignant portal vein thrombosis.
  • Patients with non-cirrhotic portal hypertension.
  • Patients refuse to participate in the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
canditates for variceal eradication; patients with documented liver cirrhosis (Based on clinical, laboratory and ultrasonographic findings) undergoing either primary or secondary prophylaxis variceal eradication at endoscopy unit of El-Rajhi hospital, Assuit University	Radiation: Abdominal computed tomography with angiography.; technique of combing a Computed Tomography scan with the injection of dye to create pictures of the portal circulation and portosystemic collaterals veins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study the effect of variceal eradication on portal circulation, liver stiffness and Child-Pugh and MELD scores in patients with liver cirrhosis.	Study the effect of variceal eradication on portal circulation and development of new portosystemic collaterals had not be found before variceal eradication in patients with liver cirrhosis	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study the effect of variceal eradication on liver stiffness and Child-Pugh and MELD scores in patient with liver cirrhosis	study how can variceal eradication affect liver elasticity, liver function so can calculate Child-Pugh and MELD scores which can life expectancy of patients with liver cirrhosis	4 years

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Esraa Swifee, Assiut University

Publications and helpful links

General Publications

• Abdel-Aty M, Fouad M, Sallam MM, Elgohary EA, Ismael A, Nawara A, Hawary B, Tag-Adeen M, Khaled S. Incidence of HCV induced-Esophageal varices in Egypt: Valuable knowledge using data mining analysis. Medicine (Baltimore). 2017 Jan;96(4):e5647. doi: 10.1097/MD.0000000000005647.
• Garcia-Tsao G, Abraldes JG, Berzigotti A, Bosch J. Portal hypertensive bleeding in cirrhosis: Risk stratification, diagnosis, and management: 2016 practice guidance by the American Association for the study of liver diseases. Hepatology. 2017 Jan;65(1):310-335. doi: 10.1002/hep.28906. Epub 2016 Dec 1. No abstract available. Erratum In: Hepatology. 2017 Jul;66(1):304.
• Augustin S, Millan L, Gonzalez A, Martell M, Gelabert A, Segarra A, Serres X, Esteban R, Genesca J. Detection of early portal hypertension with routine data and liver stiffness in patients with asymptomatic liver disease: a prospective study. J Hepatol. 2014 Mar;60(3):561-9. doi: 10.1016/j.jhep.2013.10.027. Epub 2013 Nov 6.
• Lahbabi M, Mellouki I, Aqodad N, Elabkari M, Elyousfi M, Ibrahimi SA, Benajah DA. Esophageal variceal ligation in the secondary prevention of variceal bleeding: Result of long term follow-up. Pan Afr Med J. 2013 May 3;15:3. doi: 10.11604/pamj.2013.15.3.2098. Print 2013.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2021
• Primary Completion (Anticipated): April 15, 2025
• Study Completion (Anticipated): May 15, 2025

Study Registration Dates

• First Submitted: August 30, 2020
• First Submitted That Met QC Criteria: September 2, 2020
• First Posted (Actual): September 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: portal circulation assessment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No