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

Sponsor

Pontificia Universidad Catolica de Chile (Other)

Overall Status

Completed

CT.gov ID

NCT01653171

Collaborator

(none)

230

Enrollment

Location

Arms

Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Stomach Neoplasms	Drug: Water (Placebo) Drug: Simethicone Drug: N-acetylcysteine 500 mg Drug: N-acetylcysteine 1000 mg	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

230 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Nov 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Visibility at upper endoscopy [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clinico Pontificia Universidad Catolica de Chile	Santiago	Region Metropolitana	Chile	833-0024

Sponsors and Collaborators

Pontificia Universidad Catolica de Chile

Investigators

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