Premedication With Simethicone or Simethicone Plus N-acetylcysteine in Improving Visibility During Upper Endoscopy (PRUE)
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Purpose
The purpose of this study is to determine whether premedication with Simethicone or Simethicone plus N-acetylcysteine are effective improving visibility during Upper endoscopy.
| Condition | Intervention | Phase |
|---|---|---|
|
Stomach Neoplasms |
Drug: Water (Placebo) Drug: Simethicone Drug: N-acetylcysteine 500 mg Drug: N-acetylcysteine 1000 mg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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. |
- Visibility at upper endoscopy [ Time Frame: During diagnostic upper endoscopy ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 65 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | November 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: (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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Mucolítico, Sanitas, Chile
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: Adolfo Parra-Blanco, MD | +56-2-6397780 | parrablanco@gmail.com |
| Contact: Hugo Monrroy, MD | +5697392043 | hmonrroy@gmail.com |
| Chile | |
| Hospital Clinico Pontificia Universidad Catolica de Chile | Recruiting |
| Santiago de Chile, Region Metropolitana, Chile, 833-0024 | |
| Contact: Adolfo Parra-Blanco, MD +56-2-6397780 parrablanco@gmail.com | |
| Contact: Hugo Monrroy, MD +56975392043 hmonrroy@gmail.com | |
| Principal Investigator: Adolfo Parra-Blanco, MD | |
| Principal Investigator: Hugo Monrroy, MD | |
| Principal Investigator: Esteban Glasinovic, MD | |
| Hospital Clinico Pontificia Universidad Catolica de Chile | Recruiting |
| Santiago de Chile, Region Metropolitana, Chile, 833-0024 | |
| Contact: Adolfo Parra-Blanco, MD +56-2-6397780 parrablanco@gmail.com | |
| Contact: Hugo Monrroy, MD +56975392043 hmonrroy@gmail.com | |
| Principal Investigator: Hugo Monrroy, MD | |
| Principal Investigator: Esteban Glasinovic, MD | |
| Principal Investigator: Roberto Candia, MD | |
| Principal Investigator: Adolfo Parra-Blanco, MD | |
| 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 |
More Information
Publications:
| Responsible Party: | Hugo Monrroy, Internal Medicine Physician, Gastroenterology Residency Training Program, Pontificia Universidad Catolica de Chile |
| ClinicalTrials.gov Identifier: | NCT01653171 History of Changes |
| Other Study ID Numbers: | 12-221 |
| Study First Received: | July 26, 2012 |
| Last Updated: | July 31, 2012 |
| Health Authority: | Chile: Institutional Review Board |
Keywords provided by Pontificia Universidad Catolica de Chile:
|
Acetylcysteine, Simethicone, Stomach Neoplasms |
Additional relevant MeSH terms:
|
Neoplasms Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Acetylcysteine N-monoacetylcystine Simethicone Antiviral Agents Anti-Infective Agents |
Therapeutic Uses Pharmacologic Actions Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes Emollients Dermatologic Agents |
ClinicalTrials.gov processed this record on June 17, 2013