MedTrace Logo

A Study to Evaluate Endoscopic Visibility of Stomach After a Combination Drink of N-acetylcysteine and Simethicone

NCT05801055 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-04-06

No results posted yet for this study

Summary

Endoscopy is the diagnostic modality for most gastroduodenal diseases. During endoscopy mucus and foam may actually interfere with the visibility of the stomach mucosa. So the mixture of mucolytic ( N-acetyl cysteine) and anti-foaming agents ( simethicone) agents may disperse the bubbles and mucus in the stomach and enhance gastric visibility. This unique combination drink given 20-30 minutes prior to endoscopy is absolutely safe. There are previous studies from India, which was retrospective study. So, we have planned to conduct this randomized controlled trial on this issue. Adult patients undergoing diagnostic endoscopy will be randomized and one group (100 patients) will be given the combination drink whereas another group 9100 patients) will undergo an endoscopy after overnight fasting only, as a placebo drink may actually hamper the endoscopic visibility. Our primary outcome, gastric visibility will be assessed using a standard visibility scoring system.

Conditions

  • Gastric Disease

Interventions

DRUG

Evaluation of gastric visibility following the combination drink of N-acetyle cysteine and simethocone

The combination drink containing N-acetyl cysteine and simethicone help to disperse bubbles and mucus present in the stomach. During routine upper gastrointestinal endoscopy mucus and bubbles sometimes may hinder mucosal visibility, so small submucosal lesions, ulcers, erosions, and even flat pre-malignant lesions can be missed during endoscopy. The Japanese guidelines also recommend the use of this combination drink to detect early gastric cancers. So we plan to evaluate the role of this drink in improving gastric mucosal visibility in patients undergoing upper gastrointestinal endoscopy.

Sponsors & Collaborators

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2023-06-30
Completion
2023-06-30

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05801055 on ClinicalTrials.gov