ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Gastroesophageal Varices by Transnasal Endoscopy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02767206
Recruitment Status : Unknown
Verified February 2017 by Anderson Antônio de Faria, Federal University of Minas Gerais.
Recruitment status was:  Enrolling by invitation
First Posted : May 10, 2016
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Anderson Antônio de Faria, Federal University of Minas Gerais

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.

Condition or disease
Esophageal Varices Gastric Varices Hypertension Portal Liver Cirrhosis

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
Actual Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of Gastroesophageal Varices in Cirrhotic and Non-cirrhotic Patients With Portal Hypertension by Transnasal Endoscopy.
Study Start Date : March 2016
Actual Primary Completion Date : March 2016


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



Primary Outcome Measures :
  1. Patient satisfaction through the visual analogue scale [ Time Frame: immediate ]
    Patients will be interrogated about their perception related to transnasal EGD

  2. Adverse events [ Time Frame: immediate ]
    Patients will be monitored about adverse events related to the procedure


Secondary Outcome Measures :
  1. interobserver agreement [ Time Frame: 24 weeks ]
    endoscopic images will be assessed by different endoscopists to check for interobserver agreement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Publications of Results:

Other Publications:
Responsible Party: Anderson Antônio de Faria, Principal investigator Anderson Faria, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT02767206     History of Changes
Other Study ID Numbers: TransView
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Anderson Antônio de Faria, Federal University of Minas Gerais:
Transnasal endoscopy
ultrathin endoscopes
esophageal varices
gastric varices

Additional relevant MeSH terms:
Hypertension
Liver Cirrhosis
Varicose Veins
Esophageal and Gastric Varices
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases