Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06581783
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-30
Brief Title:
Impact of Timing of Premedication on Mucosal Visibility During Endoscopy-A Randomized Controlled Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Impact of Timing of Premedication on Mucosal Visibility During Endoscopy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENDO
Brief Summary:
UGI endoscopyesophagogastroduodenoscopy 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 mucusbubbles partially obscuring views of the mucosa i E A small mucosal lesion might be missed without flushing
4 Heavy mucusbubbles obscuring views of the mucosa i E Extensive flushing is needed to avoid missing small mucosal lesions
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 mucusbubbles partially obscuring views of the mucosa i E A small mucosal lesion might be missed without flushing
4 Heavy mucusbubbles obscuring views of the mucosa i E Extensive flushing is needed to avoid missing small mucosal lesions
Detailed Description:
Procedure
Premixed medication 150mg simethicone and 600mg nac with 100ml of water was given at specified timing Primary objective - comparison of mucosal visibility between 4 groups Secondary objectives - adverse events adequate gastric mucosal visibility lesion detection rate
Premixed medication 150mg simethicone and 600mg nac with 100ml of water was given at specified timing Primary objective - comparison of mucosal visibility between 4 groups Secondary objectives - adverse events adequate gastric mucosal visibility lesion detection rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None