Liver Cirrhosis Clinical Trial
Official title:
Evaluation of Gastroesophageal Varices in Cirrhotic and Non-cirrhotic Patients With Portal Hypertension by Transnasal Endoscopy.
Verified date | February 2017 |
Source | Federal University of Minas Gerais |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Enrolling by invitation |
Enrollment | 50 |
Est. completion date | |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Federal University of Minas Gerais |
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Ilyas JA, Kanwal F. Primary prophylaxis of variceal bleeding. Gastroenterol Clin North Am. 2014 Dec;43(4):783-94. doi: 10.1016/j.gtc.2014.08.008. Review. — View Citation
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* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient satisfaction through the visual analogue scale | Patients will be interrogated about their perception related to transnasal EGD | immediate | |
Primary | Adverse events | Patients will be monitored about adverse events related to the procedure | immediate | |
Secondary | interobserver agreement | endoscopic images will be assessed by different endoscopists to check for interobserver agreement | 24 weeks |
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