Impact of Timing of Premedication on Mucosal Visibility During Endoscopy-A Randomized Controlled Trial
NCT Number: NCT06581783
Acronym: ENDO
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Endoscopy, Digestive System
Interventions: DRUG: Simethicone plus NAC
Sponsor: Asian Institute of Gastroenterology, India
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1092
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09
Completion Date: 2025-05
Locations: Asian Institute of Gastroenterology /Aig Hospitals, Hyderabad, Telangana, 500082, India

Summary:
UGI endoscopy(esophagogastroduodenoscopy) is the main diagnostic modality for direct visualization ,real time assessment and interpretation of findings encountered. The evaluation of esophagogastroduodenoscopy (EGD) quality measures encompasses several categories, such as structure, procedure, result, and adverse events. The peri-EGD period procedures fall under the procedural area, which is primarily concerned with preventing and minimising missed diagnoses.

. More aid in the identification and characterisation of gastrointestinal mucosal lesions is provided by endoscopes equipped with improved imaging technologies, such as multiband or narrow-band imaging (NBI). Despite these advancements of technological aspects, the unclean mucosal surface of the stomach can make these high-end pieces of equipment virtually useless To visualize properly and diagnose accurately there should be clear visibility of mucus apart from operator experience. Since the stage at diagnosis of upper gastrointestinal cancer is a major factor in survival, early detection is essential in improving the prognosis of patients the main factors responsible for hinderance of mucosal visibility are mucus foam and bubbles, which requires additional care for the clearance to enhance the vision and also decrease endoscopy duration by alleviating the need of repeated flushing and suctioning during endoscopy. The froth and bubbles are made of mucous secretions mixed with gastric juice and bile. Simethicone (polydimethylsiloxane and silicon dioxide) has been proven to be a promising defoaming agent as an endoscopic premedication in removing bubbles . Simethicone works by reducing the surface tension of air bubbles, and releases the trapped air by causing small bubbles to coalesce and collapse . N-acetylcysteine (nac), a mucolytic agent, has also been used as premedication acts by removing the mucous overlying the gastrointestinal mucosa 4-point scale described by Basford et al

1. No adherent mucus and clear views of the mucosa.
2. A thin coating of mucus that did not obscure views of the mucosa.
3. Some mucus/bubbles partially obscuring views of the mucosa (i. E. A small mucosal lesion might be missed without flushing
4. Heavy mucus/bubbles obscuring views of the mucosa (i. E. Extensive flushing is needed to avoid missing small mucosal lesions)

Primary Outcome Measures: comparison of mucosal visibility between 4 groups, Scores will be given based on Basford scale for esophagus, stomach (four parts: Cardia, fundus, body, antrum), Duodenum (D1, D2), score 1 indicates No adherent mucus and clear views of the mucosa, score 2 indicates A thin coating of mucus that did not obscure views of the mucosa, score 3 indicates some mucus/bubbles partially obscuring views of the mucosa score 4 indicates Heavy mucus obscuring views of the mucosa ., 10-30 minutes
Secondary Outcome Measures: To check adverse events during medication, adverse events may happen due to simethicone medicine like itching etc, 30 minutes|To identify the lesion detection rate, During endoscopy procedure with different time intervals the lesions were noted, 30 minutes