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A prospective, randomized, parallel controlled clinical study of endoscopic antireflux surgery (EARMI) in the treatment of reflux esophagitis

A prospective, randomized, parallel controlled clinical study of endoscopic antireflux surgery (EARMI) in the treatment of reflux esophagitis

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077698
Enrollment
Unknown
Registered
2023-11-16
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reflux esophagitis

Interventions

ARMS group:ARMS
ARMA group:ARMA
ARML group:ARML

Sponsors

Binzhou Medical University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) 18 to 75 years old (including 18 and 75 years old), regardless of gender; (2) received double dose PPI treatment for at least 6 months, but still had typical reflux symptoms at least twice a week; (3) gastroscopy and imaging examination met GERD standard; gastroscopy results before ARMI (LA standard); (3) esophageal hiatal hernia = 3cm. (4) pathological acid reflux was diagnosed by 24-hour esophageal pH monitoring before ARMI (defined as DeMeester score > 14.7 or acid exposure time (AET) > 4.2%); (5) able to understand the information provided and be able to comply with the requirements of the scheme; (6) voluntarily agreed to participate in this clinical trial and signed an informed consent form.

Exclusion criteria

Exclusion criteria: (1) giant sliding hernia of esophageal hiatal hernia (> 3cm sliding hiatal hernia, confirmed by one or more examinations, including endoscopy, imaging, and manometry); (2) severe systemic diseases such as Parkinson's disease, scleroderma, Sjogren's syndrome, etc.; (3) previous upper gastrointestinal surgery; (4) history of digestive system tumors and other malignant tumors. (5) patients with severe heart, liver, lung, kidney, blood, or serious diseases affecting their survival; those who could not tolerate gastroscopy, intubation, and severe hemagglutination tendency; (6) pregnant and lactating women; (7) could not cooperate to complete the research process; (8) participated in other clinical medical studies in the past 3 months; (9) the doctor judged that it was not suitable to participate in this researcher.

Design outcomes

Primary

MeasureTime frame
Esophagogastroduodenoscopy, EGD;High resolution pressure measurement;24-hour PH detection + impedance;

Secondary

MeasureTime frame
Evaluation of GERD-HRQL ;12-lead electrocardiogram;Symptom Assessment Questionnaire;Helicobacter pylori infection test;

Countries

China

Contacts

Public ContactChen Yan

Binzhou Medical University Hospital

chenyanfeihong0906@163.com+86 136 5543 8285

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026