Evaluation of Gastroesophageal Varices by Transnasal Endoscopy.

NCT ID: NCT02767206

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-03-31

Brief Summary

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.

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.

Conditions

Esophageal Varices; Gastric Varices; Hypertension Portal; Liver Cirrhosis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

portal hypertension

Patients with cirrhosis or non-cirrhotic portal hypertension.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Minas Gerais

OTHER

Sponsor Role: lead

Responsible Party

Anderson Antônio de Faria

Principal investigator Anderson Faria

Responsibility Role: PRINCIPAL_INVESTIGATOR

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Other Identifiers

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Identifier Type: -

Identifier Source: org_study_id