Esophagogastroduodenoscopy, Esophagogastroduodensocopy (EGD) Procedure, Gastritis Associated With Helicobacter Pylori, Lesions in the Esophagus, Stomach, Duodenum or Rectum, N-Acetylcysteine, Placebo - Control, Premedication, Simethicone, Tumor Gastric, Visualization
Conditions
Keywords
Esophagogastroduodenoscopy, Mucous Membrane, Premedication, Simethicone, Acetylcysteine, Gastrointestinal Tract
Brief summary
The goal of this randomized, double-blind, placebo-controlled clinical trial is to assess whether the combination of N-acetylcysteine and simethicone improves mucosal visibility during upper gastrointestinal endoscopy in adults aged 18 to 99 years of both sexes, including both healthy individuals and those with non-bleeding gastrointestinal symptoms. The main questions this study aims to answer are: Does pre-endoscopy administration of N-acetylcysteine/simethicone improve mucosal visualization based on the Toronto Upper Gastrointestinal Cleanliness Score (TUGS)? Is this combination safe and well tolerated in this patient population? Researchers will compare patients receiving N-acetylcysteine (600 mg) and simethicone (100 mg) orally 20-60 minutes before the procedure with those receiving placebo (water) to determine if there is a significant improvement in TUGS scores. Participants will: Receive a single oral dose of either N-acetylcysteine/simethicone or placebo prior to endoscopy Undergo a routine upper GI endoscopy Have mucosal cleanliness evaluated using the TUGS scoring system Be monitored for any adverse events or intolerance
Detailed description
This is a randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the efficacy of N-acetylcysteine (NAC) combined with simethicone in improving mucosal visibility during upper gastrointestinal endoscopy (UGIE). The evaluation will be based on the Toronto Upper Gastrointestinal Cleanliness Score (TUGS), a validated tool to assess mucosal cleanliness. Participants will include adult patients aged 18 to 99 years who are scheduled to undergo diagnostic UGIE for various indications and who do not present with active gastrointestinal bleeding. Eligible participants will be randomized to receive either a single dose of NAC (600 mg) plus simethicone (100 mg) or a placebo (water), administered orally 20 to 60 minutes prior to the procedure. The allocation will be blinded to both participants and endoscopists. The main objective of the study is to determine whether this premedication protocol results in better mucosal visibility, as measured by the total TUGS score. Secondary objectives include documenting the presence of significant endoscopic findings and histopathological diagnoses, and evaluating the tolerability and safety profile of the premedication. TUGS scores will be assigned by trained endoscopists blinded to the treatment allocation. Variables such as age, sex, BMI, duration of fasting, hospital site, and endoscope model will be recorded and controlled for in statistical analyses. The study will also assess any potential adverse events associated with the administration of NAC/simethicone. This study is categorized as Phase 2 because it evaluates the preliminary efficacy and short-term safety of pre-procedural oral N-acetylcysteine (NAC) and simethicone to improve mucosal visibility during diagnostic upper gastrointestinal endoscopy, using the Toronto Upper Gastrointestinal Cleaning Score (TUGCS) as a validated surrogate endpoint. Both agents have established safety profiles for other indications, but their combined use for this indication is not an approved or established standard of care. The trial is randomized, double-blind, placebo-controlled with a moderate sample size designed to estimate effect size and variability rather than to deliver definitive, multi-center confirmatory evidence on hard clinical outcomes. All procedures will adhere to ethical standards, and informed consent will be obtained from all participants. Data will be collected in a coded, anonymized format and analyzed using appropriate statistical methods, including ANCOVA and non-parametric tests where assumptions of normality are not met.
Interventions
DRUGPremedication with n-acetylcysteine
Once the sample size has been calculated, patients who meet the inclusion criteria will be recruited. who will be randomized using the Randomized for Clinical Trial program for assignment to treatment groups A and B. Group A will receive 600 mg of N-acetylcysteine and 100 mg of simethicone orally 20 to 60 minutes before the procedure, while the control group will receive an equivalent placebo infusion (composed of drinking water). Premedication and placebo will be labeled in containers as medication or placebo by external personnel not involved in the study, and the identification of each bag will be noted on a sheet and kept in an envelope that will be opened at the end of the study. Tolerance will be evaluated. If any adverse events are identified, the principal investigator will be notified for action regarding the management of the adverse event and its reporting.
DRUGPlacebo (drinking water)
The control group will receive an equivalent placebo infusion (composed of drinking water)
DRUGPremedication with simethicone
Once the sample size has been calculated, patients who meet the inclusion criteria will be recruited. who will be randomized using the Randomized for Clinical Trial program for assignment to treatment groups A and B. Group A will receive 600 mg of N-acetylcysteine and 100 mg of simethicone orally 20 to 60 minutes before the procedure, while the control group will receive an equivalent placebo infusion (composed of drinking water). Premedication and placebo will be labeled in containers as medication or placebo by external personnel not involved in the study, and the identification of each bag will be noted on a sheet and kept in an envelope that will be opened at the end of the study. Tolerance will be evaluated. If any adverse events are identified, the principal investigator will be notified for action regarding the management of the adverse event and its reporting
Sponsors
Hospital General de Mexicali
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Men and women aged 18 to 70 years old. * Patients who agree to participate in the clinical trial. * Patients without active gastrointestinal bleeding. * Signing of informed consent form.
Exclusion criteria
* Patients with a history of hypersensitivity to N-acetylcysteine * Patients with a history of hypersensitivity to simethicone * Patients with a previous endoscopic diagnosis * Patients with a history of gastric or bariatric surgery * Patients with a history of motor disorders (e.g., scleroderma, diabetic gastroparesis) * Patients taking medications that delay gastric emptying (GLP-1 analogues) * Pregnant or breastfeeding patients * Patients who do not agree to participate in the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total score on the Toronto Upper Gastrointestinal Cleaning Score (TUGCS) | During the index upper endoscopy (Day 0), scored intra-procedure (≈20-60 minutes after premedication). | The Toronto Upper Gastrointestinal Cleaning Score (TUGCS) is a validated scale that assesses mucosal cleanliness/visualization across four upper GI areas (fundus, body, antrum, and duodenum). Each area is scored from 0 to 3 (0 = poorest visualization; 3 = entire mucosa visible without suctioning/washing). The total score is the sum of all four areas (range 0-12). Higher scores indicate better mucosal cleanliness/visibility. Scoring is performed by blinded assessors during the procedure using standardized criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Mucosal Lesions | During endoscopy procedure | Number of patients in whom mucosal lesions are detected during the procedure. |
| Complete Esophageal Visualization | During endoscopy. | Binary assessment (Yes/No) of whether complete esophageal visualization was achieved. |
| Histological gastritis according to the Updated Sydney System (0-3 per item) and OLGA/OLGIM staging (0-IV) | Biopsies obtained during the index endoscopy (Day 0); histopathological report within 14 days | Measurement tool: Updated Sydney System (sum of domains not mandatory). Sites and technique: 5 gastric biopsies according to the Sydney protocol (2 antrum, 2 body, 1 incisura angularis), fixed in formalin; H&E and Giemsa staining (or IHC if necessary for H. pylori). Domains and ranges (each 0-3): H. pylori density: 0 = absent, 1 = mild, 2 = moderate, 3 = marked. Chronic inflammation (mononuclear): 0-3. Activity (neutrophils): 0-3. Glandular atrophy: 0-3. Intestinal metaplasia: 0-3. Minimum-maximum range per domain: 0-3; higher scores = worse histological severity. Risk staging: OLGA (0-IV) for atrophy, OLGIM (0-IV) for intestinal metaplasia; higher stages = worse stage/higher risk. Reported measure: distribution of scores per domain (0-3) and proportion per OLGA/OLGIM stage (0-IV), comparing arms. |
| Presence and density of Helicobacter pylori by histology (Updated Sydney System 0-3) | Biopsies obtained during the index endoscopy (Day 0); report within 14 days | Measurement tool: Updated Sydney System for H. pylori. Range and direction: 0-3 (0 = not detected; 1 = mild; 2 = moderate; 3 = marked). Higher scores = higher bacterial density. Technique: H&E + Giemsa staining (or IHC if indeterminate). Reported measure: Proportion of patients positive for H. pylori (≥1 on the scale), and Distribution of categories 0-3 per arm. |
| Number of histologically confirmed neoplasic lesions per patient | During the index endoscopy (Day 0) and histological confirmation up to 14 days | Higher values reflect higher detection performance; this should be interpreted in conjunction with the detection rate (NDR) |
Countries
Mexico
Contacts
Primary ContactLuis Andre Sanchez Perez, Resident
Backup ContactJesus Alberto Camacho Escobedo, Gastroenterologist
Outcome results
None listed