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

Phase 4
18 Years
Open (Enrolling)
Stomach Neoplasms

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Visibility at upper endoscopy

Outcome Description:

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

Outcome Time Frame:

During diagnostic upper endoscopy

Safety Issue:


Principal Investigator

Adolfo Parra-Blanco, MD

Investigator Role:

Study Director

Investigator Affiliation:

Pontificia Universidad Catolica de Chile


Chile: Institutional Review Board

Study ID:




Start Date:

July 2012

Completion Date:

November 2012

Related Keywords:

  • Stomach Neoplasms
  • Acetylcysteine, Simethicone, Stomach Neoplasms
  • Neoplasms
  • Stomach Neoplasms