An interventional study of Upper gastrointestinal endoscopy in Gerd, Esophagogastric Junction and American Foregut Society Classification, sponsored by Mohamed Abd El-Raouf Tawfik. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Mohamed Abd El-Raouf Tawfik · Not applicable, Interventional, and Diagnostic
Brief Study Summary:
This prospective randomized controlled trial evaluates the impact of procedural sedation depth on the American Foregut Society (AFS) endoscopic grading of esophagogastric junction (EGJ) integrity and its correlation with objective gastroesophageal reflux disease (GERD) severity. A total of 192 adult patients undergoing diagnostic upper endoscopy were randomly allocated across three active sedation arms (Mild, Moderate, and Deep Sedation). Using a dual assessment protocol, AFS grades were recorded before and after sedation to assess how suppressing neuromuscular reflex tone unmasks underlying structural EGJ incompetence, with results correlated against baseline validated GerdQ scores, Los Angeles esophagitis grades, and 24-hour ambulatory pH-impedance monitoring.
1,086 studies on the registry are indexed under Gastroesophageal Reflux; 187 are open to participants now.
This study's enrollment of 192 is above the median of 72 across 724 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →This is the only study on the registry with Mohamed Abd El-Raouf Tawfik as lead sponsor.
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Inclusion criteria Age 18 to 75 years Referred for diagnostic upper gastrointestinal endoscopy for evaluation of upper gastrointestinal symptoms (such as heartburn, regurgitation, chest pain, or dyspepsia) or clinical surveillance GerdQ score \ge 6 Ability to understand and provide written informed consent Exclusion Criteria Prior upper gastrointestinal, bariatric, or antireflux surgery Known primary esophageal motility disorders (e.g., achalasia, distal esophageal spasm) Large fixed hiatal hernia (\ge 5\text{ cm} or paraesophageal hernia) Active upper gastrointestinal bleeding Severe cardiopulmonary instability Pregnancy
Propofol titration targeting an Observer's Assessment of Alertness/Sedation (MOAA/S) score of 4.
Device: Upper gastrointestinal endoscopy
Propofol plus intermittent fentanyl titration targeting an MOAA/S score of 2-3.
Device: Upper gastrointestinal endoscopy
Propofol plus dexmedetomidine infusion targeting an MOAA/S score of 1-2.
Device: Upper gastrointestinal endoscopy
EGD
Also known as: Gastroscopy
Change in American Foregut Society (AFS) Endoscopic Grade from Before to After Sedation
Evaluation of esophagogastric junction (EGJ) integrity using official AFS criteria (axial length L, aperture D, and flap valve F; overall Grades I-IV) recorded immediately upon intubation (before sedation) and at peak achieved sedation depth (after sedation).
Time frame: During the diagnostic upper gastrointestinal endoscopy procedure (baseline pre-sedation vs. peak achieved sedation depth)
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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