Early gastrointestinal lesions in the upper gastrointestinal tract. Our study is not looking at the direct treatment of any particular condition, but the early detecton of lesions. When performing upper gastrointestinal endoscopy it is a common problem to find views obscured by mucous and foam. We therefore intend to use n-acetyl cysteine and Simeticone as a mucolytic agent, potentially improving views of the mucosa and therefore enabling early detection of small lesions. MedDRA version: 14.1
Conditions
Interventions
Trade Name: Parvolex
Product Name: Parvolex
Pharmaceutical Form: Solution for infusion
Trade Name: Infacol
Product Name: Simeticone
Pharmaceutical Form: Oral suspension
Sponsors
Portsmouth Hospitals NHS trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients undergoing upper gastrointestinal endoscopy at Portsmouth Hospitals NHS Trust Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 63 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 63
Exclusion criteria
Exclusion criteria: • Cases where there is significant oesophagitis preventing accurate assessment • Emergency cases (eg gastrointestinal bleeding) • Patients who would already receive NAC/Simethicone pre-endoscopy as part of their standard care • Patients with a known stricture or stenosis (narrowing) • Pregnant or breastfeeding women • Patients with a known upper gastrointestinal malignancy • Patients with a previous CVA resulting in pharyngeal weakness or paralysis • Patients with bulbar or pseudobulbar palsy • Patients with a history of previous oesophageal or gastric surgery • Patients who are currently in another clinical trial • Patients with a known allergy to NAC or Simeticone • Patients without the capacity to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if a pre-endoscopy drink of simeticone/n-acetylcysteine (a solution which will disperse bubbles and dissolve mucus) will improve views during upper gastrointestinal endoscopy (a flexible endoscopy camera examination of the gullet, stomach and duodenum). The solution will be compared to a simple water pre-endoscopy drink or no preparation.;Secondary Objective: To see if use of the solution of simeticone/n-acetylcysteine reduces the number of cleansing fluid flushes that need to be given during the procedure, and also reduces the duration of the procedure. ;Primary end point(s): Mean visibility mucosal score. Digital photographs will be taken at 4 pre-defined locations (Lower oesophagus/Upper body greater curve/Antrum/Fundus) during the procedure prior to any mucosal flushing. These images will be scored for mucosal visibility. Photographs will be rated for mucosal visibility by four experienced endoscopists (scorers). Visibility scores are rated on a four point scale (1 = no adherent mucus and clear views of the mucosa, 2 = a thin coating of mucus but not obscuring views of the mucosa, 3 = mucus/bubbles partially obscuring views of the mucosa, 4 = heavy mucus/bubbles obscuring views of the mucosa. Therefore total score based on 4 photographs ranges from 4 (best) to 16 (worst) for each scorer. The scorers will be trained in the use of the visibility score with photographic examples prior to scoring the study photographs. A pre-study test will be performed to check that there is sufficient inter-observer agreement before the study photographs are scored (Kappa value >0.4). The scorers will be blinded to the pre-endoscopy preparation relating to each photograph and the average of the four total scores will be used for each patient. ;Timepoint(s) of evaluation of this end point: Photgraphs will be taken during the procedure. These will rated later once all study photographs have been collected. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Total procedure duration 2) Volume of fluid flushes required to achieve adequate mucosal views;Timepoint(s) of evaluation of this end point: Duration and volume of flushes used will be documented on the CRF at the end of the procedure. | — |
Countries
United Kingdom
Outcome results
None listed