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Safety and efficacy of peroral endoscopic cardiac constriction in the treatment of gastroesophageal reflux disease

Comparison of peroral endoscopic cardiac constriction and proton pump inhibitors in the treatment of gastroesophageal reflux disease: a multi-center randomized control study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064133
Enrollment
Unknown
Registered
2022-09-27
Start date
2022-09-28
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

gastroesophageal reflux disease

Interventions

experimental group:peroral endoscopic cardiac constriction
Control group:proton pump inhibitors

Sponsors

The First Affiliated Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. Classic symptoms of reflux or heartburn; 3. Esophageal impedance pH monitoring showed abnormal acid reflux; 4. Esophageal manometry showed normal or subnormal lower esophageal sphincter pressure; 5. Endoscopically confirmed normal or mild esophagitis (LA grade A/B) cardia relaxation; 6. No proton pump inhibitors and other drugs affecting gastrointestinal motility were taken within 2 weeks before enrollment.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of endoscopic or surgical anti-reflux surgery; 2. Hiatal hernia diameter greater than 2 cm; 3. Patients with Barrett's esophagus or esophageal cancer diagnosed by pathological biopsy; 4. Other esophageal esophagus Patients with movement disorders; 5. Heart, lung, liver and kidney functions are not acceptable for surgery; 6. Patients with active infection or serious systemic diseases; 7. Patients with severe coagulation disorders; 8. Pregnant patients.

Design outcomes

Primary

MeasureTime frame
gastroesophageal reflux disease-health related quality of life (GERD-HRQL) score;gastroesophageal reflux disease questionnaire (GERD-Q) score;

Secondary

MeasureTime frame
DeMeester Score;Esophageal pH;Salivary pepsin;Gastroscopy;Adverse events;

Countries

China

Contacts

Public ContactZhe Shen

The First Affiliated Hospital, College of Medicine, Zhejiang University

shenzdr@zju.edu.cn+86 13656713039

Outcome results

None listed

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