Evaluation of Gastroesophageal Varices by Transnasal Endoscopy.

February 19, 2017 updated by: Anderson Antônio de Faria, Federal University of Minas Gerais

Evaluation of Gastroesophageal Varices in Cirrhotic and Non-cirrhotic Patients With Portal Hypertension by Transnasal Endoscopy.

The study aims to evaluate the feasibility of transnasal endoscopy in patients with portal hypertension, cirrhotic and non-cirrhotic. The incidence of the procedure's adverse effects, the patient's tolerance and his/her opinion about the exam are analyzed. In addition, the interobserver matched for the discoveries found in the study is carried out.

Study Overview

Status

Unknown

Conditions

Detailed Description

It is a descriptive study that proposes to evaluate the feasibility of the transnasal endoscopy to screen for gastroesophageal varices in patients with portal hypertension, cirrhotic and non-cirrhotic. The rupture of gastroesophageal varices is the principal cause of death among cirrhotics, responsible for high rates of morbidity and mortality. Current medical literature recommends that the cirrhotic and the carriers of non-cirrhotic portal hypertension screen for gastric-esophageal varices in order to establish prophylactic and therapeutic measures, when recommended. Usually, the conventional peroral esophagogastroduodenoscopy is used for such purpose but the need for sedation reduces productivity, increases costs and introduces a small but not insignificant risk concerning complications, especially in decompensated cirrhotic. For this reason, a transnasal endoscopy would be an interesting option for these patients because it does not require sedation.

The patients will be referred to endoscopy unit from general hepatology and viral hepatitis ambulatory settings. All of those who were asked to undergo esophagogastroduodenoscopy to screen for gastroesophageal varices will be invited to participate in the study, as long as they fulfill the inclusion criteria and agree to participate and sign Consent Form.

After the endoscopy, a questionnaire will be filled out with information about the exam, tolerance, incidence of adverse effects and alterations that were found. This questionnaire will have information about the liver disease cause, the cirrhosis staging to evaluate the patient's disease gravity and the patient's perception of the exam. The endoscopy will register the alterations that were found and the data about the patient's monitoring. Besides, the alterations related to the portal hypertension and afterwards the images analyzed by another endoscopist will be photographed for the matched calculation.

The results will be submitted to analysis. Statistical differences will be calculated using test "t" of student or Chi-square and significant values (p) under 0.05 considered.

Study Type

Observational

Enrollment (Actual)

50

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Endoscopies were performed in patients between 18 and 70 years with clinical, laboratory or histologic cirrhosis. They included patients of both genders who had indicated to perform transnasal endoscopy for screening of gastroesophageal varices.

Description

Inclusion Criteria:

  • The inclusion criteria were age (older than 18), clinical, laboratory or histologic diagnosis of hepatic cirrhosis or portal hypertension, and agreement to participate in the study.

Exclusion Criteria:

  • Refusal to submit to the procedure; refusal or inability to sign the term of consent; previous nasal surgery; coagulation disturbances considered as international normalized ratio more than 2, platelets below 40,000; current use of coumarins and heparin; history of repetition epistaxis; allergic rhinitis; nasal anatomic abnormality or known oropharynx; and infection of superior aerial ducts at the moment of the exam.

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

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
portal hypertension
Patients with cirrhosis or non-cirrhotic portal hypertension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction through the visual analogue scale
Time Frame: immediate
Patients will be interrogated about their perception related to transnasal EGD
immediate
Adverse events
Time Frame: immediate
Patients will be monitored about adverse events related to the procedure
immediate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
interobserver agreement
Time Frame: 24 weeks
endoscopic images will be assessed by different endoscopists to check for interobserver agreement
24 weeks

Collaborators and Investigators

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

Sponsor

Federal University of Minas Gerais

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

March 1, 2016

Primary Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

May 2, 2016

First Submitted That Met QC Criteria

May 6, 2016

First Posted (Estimate)

May 10, 2016

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 19, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TransView

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 Liver Cirrhosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe