Gastroesophageal reflux disease
Conditions
Interventions
ARMS group:Endoscopic Anti-Reflux Mucosectomy (ARMS)
ARM-P/V Group:Endoscopic Anti-Reflux Mucoplasty with Valve (ARM-P/V)
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age between 18 and 75 years, diagnosed with GERD (confirmed by endoscopy, reflux monitoring, or typical symptoms responsive to acid suppressants); (2) Ineffective after taking standard or high-dose acid suppressants for more than 8 weeks, or unwilling to take long-term medication, or unable to tolerate due to drug-related adverse reactions; (3) DeMeester score > 15 in 24-hour esophageal dynamic pH monitoring, and esophageal acid exposure time (AET) (pH 6%.
Exclusion criteria
Exclusion criteria: (1) Hiatus hernia (HH) length > 2 cm; (2) Reflux esophagitis (RE) Los Angeles classification grade C or D; (3) Long-segment Barrett's esophagus; (4) Presence of esophageal dysplasia, portal hypertension and/or esophagogastric varices, esophageal stenosis, and esophageal ulcer; (5) Presence of other motility disorders and severe failure of esophageal body peristalsis assessed by preoperative manometry. (6) Severe dysfunction of vital organs (heart, liver, kidney, etc.), combined with coagulation abnormalities, combined with other systemic diseases that make it difficult to tolerate the surgery, pregnant women, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastroesophageal Reflux Disease Health-Related Quality of Life (GERD-HRQL) questionnaire scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| GERD Questionnaire (GERD-Q);reflux severity index (RSI);the 12-items Short Form Health Survey;acid suppressant dosage;Gastroesophageal flap valve morphology (endoscopic Hill classification);24-hour esophageal dynamic pH monitoring results;High-resolution esophageal manometry (HREM); | — |
Countries
China
Contacts
Public ContactYurong Tang
The First Affiliated Hospital with Nanjing Medical University
Outcome results
None listed