Premedication With Simethicone or Simethicone Plus N-acetylcysteine in Improving Visibility During Upper Endoscopy

Stomach Neoplasms Clinical Trial

— PRUE  

Official title:

Effectiveness of Premedication With Simethicone or Simethicone Plus N-acetylcysteine vs. Placebo in Improving Visibility During Upper Endoscopy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653171
• Other study ID #: 12-221
• Status: Completed
• Phase: Phase 4
• First received: July 26, 2012
• Last updated: April 6, 2018
• Start date: July 2012
• Est. completion date: November 2013

Study information

• Verified date: April 2018
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether premedication with Simethicone or Simethicone plus N-acetylcysteine are effective improving visibility during Upper endoscopy compared with use of water or no preparation.

Description:

While globally there has been a downward trend in the incidence of gastric cancer, it remains the second leading cause of cancer mortality in the world. In Chile is the leading cause of death from malignant tumors in both sexes, and is recognized as a problem and public health priority in our country. Detection of gastric cancer in early stages has a huge impact on healing and therefore the prognosis of patients. In countries like Japan, where the incidence of this neoplasm is one of the highest in the world, mass screening programs have failed to demonstrate significant impact at the population level, there is a body of evidence to support endoscopic screening especially with the advent of new minimally invasive procedures such as endoscopic mucosal resection for gastric cancers detected in early stages. In our country, it is estimated that about half of the patients already have lymph node metastases or involvement of adjacent organs at diagnosis. The best way to reduce disease burden from this disease would be through primary prevention interventions or effective early detection. For this purpose the upper gastrointestinal endoscopy is the method of choice to examine the gastric mucosa in search of early lesions, and this is the point where adequate visibility of the mucosa is overriding. Mucus, foam and bubbles accumulated in the gastrointestinal tract mucosa interfere with adequate endoscopic visualization and thus represent risk of failing to diagnose early lesions. For this reason is that various anti-foam agents, anti-bubbles are widely used in endoscopic centers mainly in Japan, where its use is almost a rule, unlike the West where its use is limited by the theoretical risk of aspiration. Simethicone has been proven as a good anti-foam agent prior to endoscopy to remove mucus and bubbles. It has also been studied in other scenarios such as colonoscopy as an additive in the preparation of the colon to eliminate bubbles in endoscopic capsule for small bowel preparation as well as Endoscopic Ultrasound which reduces artifacts and increases the accuracy of the study. Currently N-acetylcysteine, a mucolytic agent, either alone or in combination with Simethicone has proven effective in removing mucus and gastric bubbles when used 20 minutes prior to the upper endoscopy, improving the visualization of the gastric mucosa. Other agents such as pronase have also been described as useful in this task are not yet available in our area. In the context of the relevance of gastric cancer in our environment, our low rate of early cancer detection and the absence of national policies on the preparation and agents that may improve visualization of the mucosa, this study aims to compare the effect of products available in our country in preparation for an endoscopy in order to improve visualization of the mucosa and increase the chance of recognizing early lesions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnostic upper endoscopy performed for medical indications

Exclusion Criteria:

• Upper gastrointestinal surgery

• Gastric Cancer

• Deep sedation with propofol

• Indication of therapeutic endoscopy

• Emergency endoscopy

• Patients with a history of

• Upper gastrointestinal bleeding

• Caustic ingestion

• Pregnancy

• Diabetes mellitus

• Asthma

• Allergic reactions to medication

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Drug:
• Water (Placebo)
Water 100 mL
• Simethicone
200 mg (5 mL) in water for up to 100 mL, to take 20 minutes prior to examination
• N-acetylcysteine 500 mg
500 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination
• N-acetylcysteine 1000 mg
1000 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination

Locations

Country	Name	City	State
Chile	Hospital Clinico Pontificia Universidad Catolica de Chile	Santiago	Region Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

References & Publications (20)

Albert J, Göbel CM, Lesske J, Lotterer E, Nietsch H, Fleig WE. Simethicone for small bowel preparation for capsule endoscopy: a systematic, single-blinded, controlled study. Gastrointest Endosc. 2004 Apr;59(4):487-91. — View Citation

Banerjee B, Parker J, Waits W, Davis B. Effectiveness of preprocedure simethicone drink in improving visibility during esophagogastroduodenoscopy: a double-blind, randomized study. J Clin Gastroenterol. 1992 Oct;15(3):264-5. — View Citation

Bhandari P, Green S, Hamanaka H, Nakajima T, Matsuda T, Saito Y, Oda I, Gotoda T. Use of Gascon and Pronase either as a pre-endoscopic drink or as targeted endoscopic flushes to improve visibility during gastroscopy: a prospective, randomized, controlled, — View Citation

Chang CC, Chen SH, Lin CP, Hsieh CR, Lou HY, Suk FM, Pan S, Wu MS, Chen JN, Chen YF. Premedication with pronase or N-acetylcysteine improves visibility during gastroendoscopy: an endoscopist-blinded, prospective, randomized study. World J Gastroenterol. 2 — View Citation

Chávez Rossell M. [Endoscopic treatment of early gastric cancer: from Endoscopic Mucosal Resection (EMR) to Endoscopic Submucosal Dissection (ESD)]. Rev Gastroenterol Peru. 2005 Jan-Mar;25(1):76-92. Review. Spanish. — View Citation

Csendes A, Smok G, Medina E, Salgado I, Rivera R, Quitral M. [Clinical course characteristics of gastric cancer 1958-1990]. Rev Med Chil. 1992 Jan;120(1):36-42. Spanish. — View Citation

Everett SM, Axon AT. Early gastric cancer: disease or pseudo-disease? Lancet. 1998 May 2;351(9112):1350-2. — View Citation

Fang YH, Chen CX, Zhang BL. Effect of small bowel preparation with simethicone on capsule endoscopy. J Zhejiang Univ Sci B. 2009 Jan;10(1):46-51. doi: 10.1631/jzus.B0820148. — View Citation

Fédération nationale des centres de lutte contre le cancer. [Recommendations for clinical practice: 2004 Standards, Options and Recommendations for management of patients with adenocarcinomas of the stomach (excluding cardial and other histological forms — View Citation

Kuo CH, Sheu BS, Kao AW, Wu CH, Chuang CH. A defoaming agent should be used with pronase premedication to improve visibility in upper gastrointestinal endoscopy. Endoscopy. 2002 Jul;34(7):531-4. — View Citation

Lambert R, Guilloux A, Oshima A, Pompe-Kirn V, Bray F, Parkin M, Ajiki W, Tsukuma H. Incidence and mortality from stomach cancer in Japan, Slovenia and the USA. Int J Cancer. 2002 Feb 20;97(6):811-8. — View Citation

McColl KE. Screening for early gastric cancer. Gut. 2005 Jun;54(6):740-2. — View Citation

McDonald GB, O'Leary R, Stratton C. Pre-endoscopic use of oral simethicone. Gastrointest Endosc. 1978 Nov;24(6):283. — View Citation

McNally PR, Maydonovitch CL, Wong RK. The effectiveness of simethicone in improving visibility during colonoscopy: a double-blind randomized study. Gastrointest Endosc. 1988 May-Jun;34(3):255-8. — View Citation

Ono H, Kondo H, Gotoda T, Shirao K, Yamaguchi H, Saito D, Hosokawa K, Shimoda T, Yoshida S. Endoscopic mucosal resection for treatment of early gastric cancer. Gut. 2001 Feb;48(2):225-9. — View Citation

Principles of training in gastrointestinal endoscopy. From the ASGE. American Society for Gastrointestinal Endoscopy. Gastrointest Endosc. 1999 Jun;49(6):845-53. Review. — View Citation

Sánchez del Río A, Alarcón Fernández O, Baudet JS, Sainz Menéndez Z, Socas Méndez M. Reliability of the Spanish version of a brief questionnaire on patient satisfaction with gastrointestinal endoscopy. Rev Esp Enferm Dig. 2005 Aug;97(8):554-61. English, S — View Citation

Tashiro A, Sano M, Kinameri K, Fujita K, Takeuchi Y. Comparing mass screening techniques for gastric cancer in Japan. World J Gastroenterol. 2006 Aug 14;12(30):4873-4. — View Citation

Tongprasert S, Sobhonslidsuk A, Rattanasiri S. Improving quality of colonoscopy by adding simethicone to sodium phosphate bowel preparation. World J Gastroenterol. 2009 Jun 28;15(24):3032-7. — View Citation

Yoon H, Kim N, Lee HS, Shin CM, Park YS, Lee DH, Park DJ, Kim HH, Jung HC. Effect of endoscopic screening at 1-year intervals on the clinicopathologic characteristics and treatment of gastric cancer in South Korea. J Gastroenterol Hepatol. 2012 May;27(5): — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visibility at upper endoscopy	The antrum, proximal part of the greater curvature, distal part of the greater curvature and the gastric fundus were assessed separately in terms of visibility mucosa. He scored from 1 to 4 each zone according to a score of visibility, as defined in previous publications by Chang et al. The sum of the scores from the four locations was defined as the total mucosal visibility score (TMVS) for each patient	During diagnostic upper endoscopy