About this trial
This study will recruit patients aged 18-80 with refractory gastroesophageal reflux disease (GERD). These patients had a disease course of more than six months, experienced typical symptoms such as acid reflux and heartburn, and had no symptom relief after taking a double dose of acid-suppressing medication for eight consecutive weeks. All eligible participants will undergo Endoscopic Cardial Constriction Ligation (ECCL) using a disposable endoscope. The procedure will follow a standardized protocol: mucosal and muscle layers of the cardia will be ligated at the lesser curvature, posterior wall, and greater curvature, with the ligated tissue at the greater curvature secured by a hemostatic clip. All patients will receive acid-suppressing therapy post-surgery and will be followed up at three and six months. The follow-ups will assess their GERD-Q scores, symptom relief, and incidence of complications.
Eligibility criteria
Qualifiers
(1) Age 18-80 years;
(2) Disease duration ≥6 months, with typical symptoms such as acid regurgitation and heartburn, and a confirmed diagnosis of GERD;
(3) GERD patients whose symptoms are not relieved after 8 weeks of continuous double-dose acid-suppressive therapy;
(4) Willing to participate in the study and have signed the informed consent form.
Disqualifiers
(1) Patients with precancerous lesions such as early esophageal cancer or Barrett's esophagus >3 cm, or advanced upper gastrointestinal cancer identified on endoscopy;
(2) Patients with hiatal hernia ≥2 cm, severe reflux esophagitis (LA-C or LA-D grade), esophageal or gastric varices, esophageal ulcer or stenosis, or a history of esophageal or gastric surgery;
(3) Patients with esophageal motility disorders such as achalasia or diffuse esophageal spasm, rheumatic diseases such as systemic sclerosis or Sjögren's syndrome, or eosinophilic esophagitis;
(4) Patients with a history of endoscopic or surgical anti-reflux procedures;
Trial design
Treatments tested in this trial
- endoscopic cardia constriction ligation
Treatment groups
Sponsors and collaborators
Ying Zhu
Lead sponsor
Shenzhen Hospital of Southern Medical University
Sponsor institution