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

NCT ID: NCT01653171

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-11-30

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.

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.

Conditions

Stomach Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Control

Standard upper endoscopy withouth premedication

Group Type: NO_INTERVENTION

No interventions assigned to this group

Water

100 mL of water, 20 minutes before upper endoscopy

Group Type: PLACEBO_COMPARATOR

Water (Placebo)

Intervention Type: DRUG

Water 100 mL

Simethicone

Simethicone 200 mg, in water for up to 100 mL, to take 20 minutes prior to examination

Group Type: EXPERIMENTAL

Simethicone

Intervention Type: DRUG

200 mg (5 mL) in water for up to 100 mL, to take 20 minutes prior to examination

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

Group Type: EXPERIMENTAL

Simethicone

Intervention Type: DRUG

200 mg (5 mL) in water for up to 100 mL, to take 20 minutes prior to examination

N-acetylcysteine 500 mg

Intervention Type: DRUG

500 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination

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

Group Type: EXPERIMENTAL

Simethicone

Intervention Type: DRUG

200 mg (5 mL) in water for up to 100 mL, to take 20 minutes prior to examination

N-acetylcysteine 1000 mg

Intervention Type: DRUG

1000 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination

Interventions

Water (Placebo)

Water 100 mL

Intervention Type: DRUG

Simethicone

200 mg (5 mL) in water for up to 100 mL, to take 20 minutes prior to examination

Intervention Type: DRUG

N-acetylcysteine 500 mg

500 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination

Intervention Type: DRUG

N-acetylcysteine 1000 mg

1000 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination

Intervention Type: DRUG

Other Intervention Names

(Placebo); Flapex, Andromaco, Chile; Mucolítico, Sanitas, Chile; Mucolítico, Sanitas, Chile

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Hugo Monrroy

Internal Medicine Physician, Gastroenterology Residency Training Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adolfo Parra-Blanco, MD

Role: STUDY_DIRECTOR

Pontificia Universidad Catolica de Chile

Esteban Glasinovic, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica

Hugo Monrroy, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Roberto Candia, MD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Locations

Hospital Clinico Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, Chile

Countries

Chile

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Other Identifiers

12-221

Identifier Type: -

Identifier Source: org_study_id