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临床试验/NCT05801055
NCT05801055尚未招募3 期

Improvement in Endoscopic Mucosal Visibility Using a Pre-procedure Combination Drink of N-acetylcysteine and Simethicone: A Randomized Controlled Trial

Sanjay Gandhi Postgraduate Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
尚未招募
入组人数
200
试验地点
1
主要终点
Any change in adequate visibility between the two groups.

研究概览

简要总结

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.

详细描述

Improvement in endoscopic mucosal visibility using a pre-procedure combination drink of N-acetylcysteine and simethicone: A Randomized controlled trial

Introduction:

Upper gastrointestinal endoscopy (UGIE) is one of the most frequently performed procedures for diagnosing and treating GI and liver-related disorders. Pre-procedure preparation and reporting of adequate preparation is the standard of care for colonoscopies but there is not uniformity in preparation for UGIE. Various studies have demonstrated that the incidence of missed diagnosis in endoscopies can be brought down by improving mucosal visibility. Endoscopic mucosal visibility can be impaired by various factors like poor technique, excessive mucus, residual food, inappropriate positioning, and more importantly the presence of mucosal froth and bubbles in the GI tract. Gastro-duodenal mucosa is lined by mucus comprising 95% water and 5% cross-linked glycoprotein(GP), which keeps mucus viscous and liquid. With fasting, GP content decreases making mucus more sticky. Several mucolytic and anti-foaming agents including pronase, simethicone, and N acetyl-cysteine(NAC) have been tried for this purpose. NAC is a derivative of the natural amino acid L-cysteine. It breaks the disulfide bridges in high molecular weight glycoproteins. Simethicone (polydimethylsiloxane or dimethicone + SiO2) is an anti-foaming surface-acting agent, which acts by reducing the surface tension of air bubbles, surface viscosity, and hydrophobicity. Simethicone is virtually non-toxic, without any drug interaction or systemic toxicity. Multiple studies have been conducted showing the safety and efficacy of simethicone, NAC, and their combination for improving endoscopic visibility. These pre-medications are already used for improving endoscopic visibility to detect early esophageal and gastric cancer.

Some studies from the western countries as well as the eastern world have highlighted the significant role of mucolytic and anti-foaming agents in improving mucosal visibility.

Monrroy et al, in 2017 conducted a double-blind randomized control trial in which 230 patients were divided into 5 groups (46 each) i.e no intervention group, water 100 ml (W) group, and interventional groups comprised of simethicone alone (S), simethicone plus NAC 500 mg (S + NAC500) and simethicone plus NAC1000 group. The solution was ingested 20 minutes before the UGIE. Gastric visibility was assessed in 4 segments using a pre-validated mucosal visibility scoring system based on a Likert scale and adequate visibility was defined as a score less than 7. In this study, they found that premedication by S+NAC500 and S+NAC100 improved visibility whereas visibility was worst in the W group.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consecutive patients presenting for ambulatory diagnostic endoscopy
  • Willing Informed consent
  • Age 18-75 years

排除标准

  • 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.

研究组 & 干预措施

Arm 1

Experimental

Arm which will be randomised to get the combination drink prior to the diagnostic endoscopy

干预措施: Evaluation of gastric visibility following the combination drink of N-acetyle cysteine and simethocone (Drug)

结局指标

主要结局

Any change in adequate visibility between the two groups.

时间窗: Upto three months

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).

次要结局

  • 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)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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