Randomized Controlled Trial to Evaluate the Effect of Premedication With N-acetylcysteine and Simethicone on Mucosal Visibility During Elective Upper Gastrointestinal Endoscopy Using the TUGS Score
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 132
- 试验地点
- 2
- 主要终点
- Total score on the Toronto Upper Gastrointestinal Cleaning Score (TUGCS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Patients receiving n-acetylcysteine/simethicone
干预措施: Premedication with n-acetylcysteine (Drug)
Patients receiving n-acetylcysteine/simethicone
干预措施: Premedication with simethicone (Drug)
Patients receiving placebo
干预措施: Placebo (drinking water) (Drug)
结局指标
主要结局
Total score on the Toronto Upper Gastrointestinal Cleaning Score (TUGCS)
时间窗: 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.
次要结局
- Detection of Mucosal Lesions(During endoscopy procedure)
- Complete Esophageal Visualization(During endoscopy.)
- 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)
- 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)
- Number of histologically confirmed neoplasic lesions per patient(During the index endoscopy (Day 0) and histological confirmation up to 14 days)