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

April 6, 2018 updated by: Hugo Monrroy, Pontificia Universidad Catolica de Chile

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • Region Metropolitana
      • Santiago, Region Metropolitana, Chile, 833-0024
        • Hospital Clínico Pontificia Universidad Católica de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard upper endoscopy withouth premedication
Placebo Comparator: Water
100 mL of water, 20 minutes before upper endoscopy
Drug: Water (Placebo)
Water 100 mL
Other Names:
  • (Placebo)
Experimental: Simethicone
Simethicone 200 mg, in water for up to 100 mL, to take 20 minutes prior to examination
Drug: Simethicone
200 mg (5 mL) in water for up to 100 mL, to take 20 minutes prior to examination
Other Names:
  • Flapex, Andromaco, Chile
Experimental: N-acetylcysteine 500 mg + Simethicone
N-acetylcysteine 500 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination
Drug: Simethicone
200 mg (5 mL) in water for up to 100 mL, to take 20 minutes prior to examination
Other Names:
  • Flapex, Andromaco, Chile
Drug: N-acetylcysteine 500 mg
500 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination
Other Names:
  • Mucolítico, Sanitas, Chile
Experimental: N-acetylcysteine 1000 mg + Simethicone
N-acetylcysteine 1000 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination
Drug: Simethicone
200 mg (5 mL) in water for up to 100 mL, to take 20 minutes prior to examination
Other Names:
  • Flapex, Andromaco, Chile
Drug: N-acetylcysteine 1000 mg
1000 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination
Other Names:
  • Mucolítico, Sanitas, Chile

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visibility at upper endoscopy
Time Frame: During diagnostic 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Investigators

  • Study Director: Adolfo Parra-Blanco, MD, Pontificia Universidad Catolica de Chile
  • Principal Investigator: Esteban Glasinovic, MD, Pontificia Universidad Católica
  • Principal Investigator: Hugo Monrroy, MD, Pontificia Universidad Catolica de Chile
  • Principal Investigator: Roberto Candia, MD, Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

July 26, 2012

First Submitted That Met QC Criteria

July 27, 2012

First Posted (Estimate)

July 30, 2012

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 6, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-221

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stomach Neoplasms

Clinical Trials on Water (Placebo)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe