Evaluation of Gastroesophageal Varices by Transnasal Endoscopy.

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02767206
• Other study ID #: TransView
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 2, 2016
• Last updated: February 19, 2017
• Start date: March 2016

Study information

• Verified date: February 2017
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• 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.

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Esophageal Varices
• Gastric Varices
• Hypertension
• Hypertension Portal
• Hypertension, Portal
• Liver Cirrhosis
• Varicose Veins

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

References & Publications (25)

Aedo MR, Zavala-González MÁ, Meixueiro-Daza A, Remes-Troche JM. Accuracy of transnasal endoscopy with a disposable esophagoscope compared to conventional endoscopy. World J Gastrointest Endosc. 2014 Apr 16;6(4):128-36. doi: 10.4253/wjge.v6.i4.128. — View Citation

Ai ZL, Lan CH, Fan LL, Lan L, Cao Y, Li P, Song O, Chen DF. Unsedated transnasal upper gastrointestinal endoscopy has favorable diagnostic effectiveness, cardiopulmonary safety, and patient satisfaction compared with conventional or sedated endoscopy. Sur — View Citation

Alexandridis E, Inglis S, McAvoy NC, Falconer E, Graham C, Hayes PC, Plevris JN. Randomised clinical study: comparison of acceptability, patient tolerance, cardiac stress and endoscopic views in transnasal and transoral endoscopy under local anaesthetic. — View Citation

Arantes V, Albuquerque W, Salles JM, Freitas Dias CA, Alberti LR, Kahaleh M, Ferrari TC, Coelho LG. Effectiveness of unsedated transnasal endoscopy with white-light, flexible spectral imaging color enhancement, and lugol staining for esophageal cancer scr — View Citation

ASGE Technology Committee., Rodriguez SA, Banerjee S, Desilets D, Diehl DL, Farraye FA, Kaul V, Kwon RS, Mamula P, Pedrosa MC, Varadarajulu S, Song LM, Tierney WM. Ultrathin endoscopes. Gastrointest Endosc. 2010 May;71(6):893-8. doi: 10.1016/j.gie.2010.01 — View Citation

Assy N, Rosser BG, Grahame GR, Minuk GY. Risk of sedation for upper GI endoscopy exacerbating subclinical hepatic encephalopathy in patients with cirrhosis. Gastrointest Endosc. 1999 Jun;49(6):690-4. — View Citation

Atar M, Kadayifci A. Transnasal endoscopy: Technical considerations, advantages and limitations. World J Gastrointest Endosc. 2014 Feb 16;6(2):41-8. doi: 10.4253/wjge.v6.i2.41. Review. — View Citation

Bosch J, Pizcueta P, Feu F, Fernández M, García-Pagán JC. Pathophysiology of portal hypertension. Gastroenterol Clin North Am. 1992 Mar;21(1):1-14. Review. — View Citation

Boyer TD. Natural history of portal hypertension. Clin Liver Dis. 1997 May;1(1):31-44, x. Review. — View Citation

Choe WH, Kim JH, Ko SY, Kwon SY, Kim BK, Rhee KH, Seo TH, Lee TY, Hong SN, Lee SY, Sung IK, Park HS, Shim CS. Comparison of transnasal small-caliber vs. peroral conventional esophagogastroduodenoscopy for evaluating varices in unsedated cirrhotic patients — View Citation

Ciriza de los Ríos C, Fernández Eroles AL, García Menéndez L, Carneros Martín JA, Díez Hernández A, Delgado Gómez M. [Sedation in upper gastrointestinal endoscopy. Analysis of tolerance, complications and cost-effectiveness]. Gastroenterol Hepatol. 2005 J — View Citation

D'Amico G, Pagliaro L, Bosch J. Pharmacological treatment of portal hypertension: an evidence-based approach. Semin Liver Dis. 1999;19(4):475-505. Review. Erratum in: Semin Liver Dis 2000;20(3):399. — View Citation

Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W; Practice Guidelines Committee of the American Association for the Study of Liver Diseases.; Practice Parameters Committee of the American College of Gastroenterology.. Prevention and management of gastroesophag — View Citation

Graham DY, Smith JL. The course of patients after variceal hemorrhage. Gastroenterology. 1981 Apr;80(4):800-9. — View Citation

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

Jobe BA, Hunter JG, Chang EY, Kim CY, Eisen GM, Robinson JD, Diggs BS, O'Rourke RW, Rader AE, Schipper P, Sauer DA, Peters JH, Lieberman DA, Morris CD. Office-based unsedated small-caliber endoscopy is equivalent to conventional sedated endoscopy in scree — View Citation

Kawai T, Miyazaki I, Yagi K, Kataoka M, Kawakami K, Yamagishi T, Sofuni A, Itoi T, Moriyasu F, Osaka Y, Takagi Y, Aoki T. Comparison of the effects on cardiopulmonary function of ultrathin transnasal versus normal diameter transoral esophagogastroduodenos — View Citation

Lee SY, Kawai T. Transnasal route: new approach to endoscopy. Gut Liver. 2008 Dec;2(3):155-65. doi: 10.5009/gnl.2008.2.3.155. — View Citation

Pungpapong S, Keaveny A, Raimondo M, Dickson R, Woodward T, Harnois D, Wallace M. Accuracy and interobserver agreement of small-caliber vs. conventional esophagogastroduodenoscopy for evaluating esophageal varices. Endoscopy. 2007 Aug;39(8):673-80. — View Citation

Standards of Practice Committee of the American Society for Gastrointestinal Endoscopy., Lichtenstein DR, Jagannath S, Baron TH, Anderson MA, Banerjee S, Dominitz JA, Fanelli RD, Gan SI, Harrison ME, Ikenberry SO, Shen B, Stewart L, Khan K, Vargo JJ. Seda — View Citation

Stroppa I, Grasso E, Paoluzi OA, Razzini C, Tosti C, Andrei F, Biancone L, Palmieri G, Romeo F, Pallone F. Unsedated transnasal versus transoral sedated upper gastrointestinal endoscopy: a one-series prospective study on safety and patient acceptability. — View Citation

Tao G, Xing-Hua L, Ai-Ming Y, Wei-Xun Z, Fang Y, Xi W, Li-Yin W, Chong-Mei L, Gui-Jun F, Hui-Jun S, Dong-Sheng W, Yue L, Xiao-Qing L, Jia-Ming Q. Enhanced magnifying endoscopy for differential diagnosis of superficial gastric lesions identified with white — View Citation

Trevisani L, Cifalà V, Sartori S, Gilli G, Matarese G, Abbasciano V. Unsedated ultrathin upper endoscopy is better than conventional endoscopy in routine outpatient gastroenterology practice: a randomized trial. World J Gastroenterol. 2007 Feb 14;13(6):90 — View Citation

Triantafillidis JK, Merikas E, Nikolakis D, Papalois AE. Sedation in gastrointestinal endoscopy: current issues. World J Gastroenterol. 2013 Jan 28;19(4):463-81. doi: 10.3748/wjg.v19.i4.463. Review. — View Citation

Triantos C, Kalafateli M. Primary prevention of bleeding from esophageal varices in patients with liver cirrhosis. World J Hepatol. 2014 Jun 27;6(6):363-9. doi: 10.4254/wjh.v6.i6.363. Review. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

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