Evaluation of Gastroesophageal Varices by Transnasal Endoscopy.

NCT02767206 | Unknown

• 1 other identifier: TransView
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Esophageal Varices; Gastric Varices; Hypertension Portal; Liver Cirrhosis

Keywords

Transnasal endoscopy; ultrathin endoscopes; esophageal varices; gastric varices

Outcome Measures

Primary Outcomes (2)

• Patient satisfaction through the visual analogue scale

  Patients will be interrogated about their perception related to transnasal EGD

  immediate

• Adverse events

  Patients will be monitored about adverse events related to the procedure

  immediate

Secondary Outcomes (1)

• interobserver agreement

  24 weeks

Study Arms (1)

portal hypertension

Patients with cirrhosis or non-cirrhotic portal hypertension.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Related Publications (25)

• 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.

  PMID: 25018847 BACKGROUND

• Aedo MR, Zavala-Gonzalez MA, 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.

  PMID: 24748920 RESULT

• 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. Surg Endosc. 2012 Dec;26(12):3565-72. doi: 10.1007/s00464-012-2367-4. Epub 2012 Sep 14.

  PMID: 22976847 RESULT

• 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. Aliment Pharmacol Ther. 2014 Sep;40(5):467-76. doi: 10.1111/apt.12866. Epub 2014 Jul 9.

  PMID: 25039412 RESULT

• 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 screening in high-risk patients. J Clin Gastroenterol. 2013 Apr;47(4):314-21. doi: 10.1097/MCG.0b013e3182617fc1.

  PMID: 23059405 RESULT

• 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. doi: 10.1016/s0016-5107(99)70283-x.

  PMID: 10343210 RESULT

• 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.

  PMID: 24567791 RESULT

• Bosch J, Pizcueta P, Feu F, Fernandez M, Garcia-Pagan JC. Pathophysiology of portal hypertension. Gastroenterol Clin North Am. 1992 Mar;21(1):1-14.

  PMID: 1568769 RESULT

• Boyer TD. Natural history of portal hypertension. Clin Liver Dis. 1997 May;1(1):31-44, x. doi: 10.1016/s1089-3261(05)70253-1.

  PMID: 15562666 RESULT

• 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. Endoscopy. 2011 Aug;43(8):649-56. doi: 10.1055/s-0030-1256474. Epub 2011 Jun 9.

  PMID: 21660907 RESULT

• Ciriza de los Rios C, Fernandez Eroles AL, Garcia Menendez L, Carneros Martin JA, Diez Hernandez A, Delgado Gomez M. [Sedation in upper gastrointestinal endoscopy. Analysis of tolerance, complications and cost-effectiveness]. Gastroenterol Hepatol. 2005 Jan;28(1):2-9. doi: 10.1157/13070376. Spanish.

  PMID: 15691461 RESULT

• D'Amico G, Pagliaro L, Bosch J. Pharmacological treatment of portal hypertension: an evidence-based approach. Semin Liver Dis. 1999;19(4):475-505. doi: 10.1055/s-2007-1007133.

  PMID: 10643630 RESULT

• 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 gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007 Sep;46(3):922-38. doi: 10.1002/hep.21907. No abstract available.

  PMID: 17879356 RESULT

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

  PMID: 6970703 RESULT

• 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. Epub 2014 Sep 22.

  PMID: 25440925 RESULT

• 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 screening and surveillance for Barrett's esophagus: a randomized and blinded comparison. Am J Gastroenterol. 2006 Dec;101(12):2693-703. doi: 10.1111/j.1572-0241.2006.00890.x.

  PMID: 17227516 RESULT

• 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 esophagogastroduodenoscopy in Japan. Hepatogastroenterology. 2007 Apr-May;54(75):770-4.

  PMID: 17591059 RESULT

• 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. Epub 2008 Dec 31.

  PMID: 20485641 RESULT

• 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. Sedation and anesthesia in GI endoscopy. Gastrointest Endosc. 2008 Nov;68(5):815-26. doi: 10.1016/j.gie.2008.09.029. No abstract available.

  PMID: 18984096 RESULT

• 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. doi: 10.1055/s-2007-966351. Epub 2007 Jun 22.

  PMID: 17583856 RESULT

• 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.2010.01.022. No abstract available.

  PMID: 20438882 RESULT

• 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. Dig Liver Dis. 2008 Sep;40(9):767-75. doi: 10.1016/j.dld.2008.02.033. Epub 2008 Apr 18.

  PMID: 18424197 RESULT

• 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-light endoscopy. Gastric Cancer. 2014 Jan;17(1):122-9. doi: 10.1007/s10120-013-0250-1. Epub 2013 Mar 14.

  PMID: 23494118 RESULT

• 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.

  PMID: 23382625 RESULT

• Trevisani L, Cifala 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):906-11. doi: 10.3748/wjg.v13.i6.906.

  PMID: 17352021 RESULT

MeSH Terms

Conditions

Esophageal and Gastric Varices; Hypertension, Portal; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator Anderson Faria

Study Record Dates

• First Submitted: May 2, 2016
• First Posted: May 10, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02