A Study to Evaluate Endoscopic Visibility of Stomach After a Combination Drink of N-acetylcysteine and Simethicone
Improvement in Endoscopic Mucosal Visibility Using a Pre-procedure Combination Drink of N-acetylcysteine and Simethicone: A Randomized Controlled Trial
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Apr 2023
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2023
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedFirst Posted
Study publicly available on registry
April 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedApril 6, 2023
February 1, 2023
3 months
March 6, 2023
April 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Any change in adequate visibility between the two groups.
The difference in adequate visibility between the two groups. Gastric total visibility score (TVS) will be used as proposed by Monrroy et al. It will be calculated by assessment of mucosal visibility on a Likert scale of 1 to 4 in areas of the gastric antrum, lower gastric body, upper gastric body and fundus. A TVS \<7 will be used to define adequate visibility (AV).
Upto three months
Secondary Outcomes (3)
Any change in endoscopy time
Upto one week
The rate of adverse outcome
Upto one week
The rate of gastric mucosal lesion yield
Upto one week
Study Arms (2)
Arm 1
EXPERIMENTALArm which will be randomised to get the combination drink prior to the diagnostic endoscopy
Arm 2
NO INTERVENTIONComparator arm where endoscopy will be done without any drink
Interventions
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.
Eligibility Criteria
You may qualify if:
- Consecutive patients presenting for ambulatory diagnostic endoscopy
- Willing Informed consent
- Age 18-75 years
You may not qualify if:
- Patients undergoing therapeutic endoscopy
- Patients undergoing emergency endoscopy
- Deeply sedated \& anesthetized patients
- Pregnant patients
- Clinically suspected motility disorders (gastroparesis, achalasia)
- Patients with esophageal stricture
- Patients with gastric outlet obstruction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)
Lucknow, Uttar Pradesh, 226014, India
Related Publications (2)
Monrroy H, Vargas JI, Glasinovic E, Candia R, Azua E, Galvez C, Rojas C, Cabrera N, Vidaurre J, Alvarez N, Gonzalez J, Espino A, Gonzalez R, Parra-Blanco A. Use of N-acetylcysteine plus simethicone to improve mucosal visibility during upper GI endoscopy: a double-blind, randomized controlled trial. Gastrointest Endosc. 2018 Apr;87(4):986-993. doi: 10.1016/j.gie.2017.10.005. Epub 2017 Oct 14.
PMID: 29037773BACKGROUNDAnikhindi SA, Kumar A, Uedo N, Singla V, Anikhindi A, Sharma P et al. Pre-endoscopy drink of simethicone and N-acetylcysteine significantly improves visualization in upper gastrointestinal endoscopy. J Dig Endosc. 2021;12(1):11-8. doi: 10.1055/s-0041-1726225.
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2023
First Posted
April 6, 2023
Study Start
April 1, 2023
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
April 6, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share